US Product Master Data Quick Reference

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US Product Master Data Quick Reference The following tables specify the Product Master Data required for compliance regulations. You can enter the data in the user interface or by uploading a CSV file. The first column shows the user interface field name for the data, as well as the CSV column name. Product Information Fields Field Name / CSV Column Name

Description

Product Group Code

Category code your company uses for this product.

ProductGroupCode

Values

* Required for all countries. Data Status DataStatus

Status of the product in the system. Set to Active to ensure that transaction feeds are successful.

Active Inactive

* Required for all countries. Item Status

Production status of the product.

Released

ItemStatus

* Required for all countries.

Alternate items available Phase out Items no longer stocked Withdrawn

Item Code Fields Field Name / CSV Column Name

Description

Values

Item Code Type

The item code type your company uses to identify products, for example, Internal Product Code or Country Drug Code.

See Item Code Types on page 8.

ItemCodeType Item Code Value ItemCodeValue

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The item code corresponding to the item code type you selected.

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Field Name / CSV Column Name

Description

Values

Primary Item Code

Indicates whether or not the item code is the primary item code.

Yes

ItemCodePrimary

No

For uploading using a CSV file, the first item code must be the primary item code. (ItemCodePrimary must be set to Yes.)

Target Markets Fields Field Name / CSV Column Name

Description

Values

Country Market Code

Country code of the target market. Click the

See Country Codes on page 9.

CountryMarket

drop-down icon

and

select a country. You can enter the first few characters of the country to filter the list. Note: The required fields change based on the Country Market Code. Point of Dispense Verification CountryMarketPointofDispenseVerification

Indicates whether the target market requires verification when it is dispensed.

Not Required

For the US market, enter Not Required.

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Field Name / CSV Column Name

Description

Values

Traceability Required

Indicates whether traceability laws apply to the product.

Required

CountryMarketTraceabilityRequired

Not Required

* Required field if Country Market Code is US. Set Traceability Required to Required for US products unless a product is exempt from DSCSA traceability, for example, an over-thecounter product or medical device.

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Field Name / CSV Column Name

Description

Values

Product Origin

Indicates the relationship of the purchaser to the originator of the product. Regulatory laws require different data for sales transactions depending on whether a company is the product originator,

Direct Purchase from Exclusive Distributor: Choose if you are purchasing the product from an exclusive distributor, who purchased from the originator of the product.

CountryMarketProductOrigin

has purchased directly from the product originator, or has purchased from an intermediary. * Required field if Country Market Code is US.

Direct Purchase from Manufacturer: Choose if you are purchasing the product from a manufacturer, who purchased from the originator of the product. Direct Purchase from Repackager: Choose if you are purchasing the product from a repackager, who purchased from the originator of the product. Indirect Purchase: Select if the company is not purchasing from the originator of the product, but instead, through an intermediary. Originator (Exclusive Distributor): Choose if you are the exclusive distributor, the originator of the product. Originator (Manufacturer): Choose if you are the manufacturer, the originator of the product.

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Item Information Fields Field Name / CSV Column Name

Description

Values

Language Code

The language in which the item information is defined.

English

ItemInfoLanguageCode

* Must include English for US, IN [India] and EU FMD compliant countries. Product Description

A description that typically

ItemInfoProductDescription

includes the product name and strength * Required for all countries.

Product Name ItemInfoDrugName

The name of the product as it appears on the packaging. * For EU FMD compliant countries, this should include the name + strength + dosage form . * Required for all countries.

Generic Name ItemInfoGenericName

The generic (non-proprietary) item name. * Required field if the Target Markets tab includes US (United States). You add a target market by using the Country Market Code on the Target Markets tab.

Manufacturer ItemInfoManufacturer

The company name of the manufacturer. * Required for all countries.

Strength ItemInfoStrength

Specify the strength of product, for example, 20MG. * Required field if the Target Markets tab includes US (United States).

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Field Name / CSV Column Name

Description

Dosage Form

The unit dose of the product, for example, tablet, capsule, syrup.

ItemInfoDosageForm

Values

* Required field if the Target Markets tab includes US and the Language Code is English and the Product Type is not Medical Device, OTC Drug, Nutritional Product, or Derivative Product. Package Size / Spec

The number of units in a package.

ItemInfoPackageSize

* Required field if the Target Markets tab includes US and the Language Code is English and the Product Type is not Medical Device, OTC Drug, Nutritional Product, or Derivative Product.

Packaging Information Fields

Note: To track lot-level operations, you do not need to complete the Packaging Information fields. Complete these fields only if you are tracking serialized operations. Field Name / CSV Column Name

Description

Packaging Code Type

The packaging code type used GTIN-12 to specify the packaging code. GTIN-13 Select what’s appropriate for the locale where you are selling GTIN-14 the product and for the packaging level.

PackagingCodeType

Values

When you select a packaging code type, the fields required for that code type are displayed. * If you use the Packaging Information tab, the Packaging Code Type field is required. Packaging Code PackagingCode

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The value for the selected Packaging Code Type.

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Field Name / CSV Column Name

Description

Values

Packaging UOM

A unit of measure for the item depending on the Packaging Code Type you entered.

Each

PackagingUOM

* If you use the Packaging Information tab, the Packaging UOM field is required. Packaging Ratio PackagingRatio

Batch Size Max / Acceptable / Min BatchSizeMaximum AcceptableYield MinimumYield

Serialization Type PackagingSerializationType

Inner Pack/Bundle Case/Shipper Pallet

A ratio of the number of units in each packaging level. For example, if an inner pack is made of 12 eaches and a case is made of 16 inner packs, the Packaging Ratio is: 1:16:192. Thus a case contains 192 eaches. Batch threshold parameters that Max is an integer. can be assigned for the Each Acceptable and Min are unit of measure. percentages. * Batch Size Max required if Acceptable Yield or Minimum Yield Percentage are entered. Indicates the order in which TraceLink will generate serial numbers.

None Random Sequential

Requires Aggregation PackagingRequiresAggregation Filter Value PackagingFilterValue

Indicates whether the product will be configured for aggregation when serialized.

Aggregated

A value 0 -7 sometimes used to represent a packaging level. Your company defines which values correspond to which packaging levels. For example, you might use 0 for eaches, 1 for cases, and so on.

0-7

Not Aggregated

* Required field for GTIN-14

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Field Name / CSV Column Name

Description

GS1 Company Prefix

Your company’s GS1 Company Prefix.

PackagingGS1CompanyPrefix

Values

* Required field for GTIN-13, GTIN-14, NTIN Data Status

Enter Active if the product is currently being sold; otherwise, enter Inactive.

PackagingDataStatus

Active Inactive

Item Code Types This table lists item code types and their value lengths. If uploading Master Data using a CSV file, enter the value from the Item Code Type column into the ItemCodeType column. The ItemCodeValue must be in the format indicated in the Item Code Value Length column. Item Code Type

Used in

Item Code Value Length

AT – PZN

Austria

13 digits.

BE – ABP Code

Belgium

16 digits.

BR – Anvisa Registration Number*

Brazil

13 digits. Can include hyphens. Hyphens are stripped out to ensure there are 13 digits.

CA – DIN

Canada

8 digits.

CH – Swissmedic

Switzerland

13 digits.

CN – Subtype Code*

China

10 digits

DE – PPN

Germany

12 digits

DE – PZN

Germany

8 digits

EAN13

International

13 digits

ES – Codigo National

Spain

13 digits

FR – CIP-13 Code

France

13 digits

IN – Product Code*

India

12 digits

Internal Material Number

Used internally by your company and partners

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Item Code Type

Used in

Item Code Value Length

IT – Bollino

Italy

9 digits

KR – KFDA Code*

South Korea

13 digits

NL – KNMP

Netherlands

8 digits

NRD – Nordic VNR Drug Code

Finland, Sweden, Denmark, Norway, Iceland

6 digits

PT – AIM Number

Portugal

7 digits

SA – Saudi Drug Code

Saudi Arabia

10 digits

US – NDC442**

United States

10 (without hyphens) or 12 (with hyphens)

US – NDC532**

United States

10 (without hyphens) or 12 (with hyphens)

US – NDC541**

United States

10 (without hyphens) or 12 (with hyphens)

US – NDC542**

United States

11 (without hyphens) or 13 (with hyphens)

* Indicates the code is required for that country’s Compliance Reports. ** For the US, at least one of these codes needs to be used to comply with DSCSA.

Country Codes This table lists the Country and the two-letter country code. The third column indicates if the country is part of the European Union. If uploading the Master Data using a CSV file, enter the two-letter country code in all country code fields in the CSV file. Country Codes Country Code

Country

AE

United Arab Emirates

AF

Afghanistan

AG

Antigua and Barbuda

AI

Anguilla

AL

Albania

AM

Armenia

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EU FMD Compliant?

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Country Code

Country

AN

Netherland Antilles

AO

Angola

AQ

Antarctica

AR

Argentina

AS

American Samoa

AT

Austria

AU

Australia

AW

Aruba

AX

Aland Islands

AZ

Azerbaijan

BA

Bosnia and Herzegovina

BB

Barbados

BD

Bangladesh

BE

Belgium

BF

Burkina Faso

BG

Bulgaria

BH

Bahrain

BI

Burundi

BJ

Benin

BL

Saint Barthelemy

BM

Bermuda

BN

Brunei Darussalam

BO

Bolivia, Plurinational State of

BQ

Bonaire, Sint Eustatius and Saba

BR

Brazil

BS

Bahamas

BT

Bhutan

BV

Bouvet Island

BW

Botswana

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EU FMD Compliant?

Yes

Yes

Yes

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Country Code

Country

BY

Belarus

BZ

Belize

CA

Canada

CC

Cocos (Keeling) islands

CD

Congo, the Democratic Republic of the

CF

Central African Republic

CG

Congo

CH

Switzerland

CI

Cote d’Ivoire

CK

Cook Islands

CL

Chile

CM

Cameroon

CN

China

CO

Colombia

CR

Costa Rica

CU

Cuba

CV

Cape Verde

CW

Curacao

CX

Christmas Island

CY

Cyprus

Yes

CZ

Czech Republic

Yes

DE

Germany

Yes

DJ

Dijbouti

DK

Denmark

DM

Dominica

DO

Dominican Republic

DZ

Algeria

EC

Ecuador

EE

Estonia

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EU FMD Compliant?

Yes

Yes

Yes

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Country Code

Country

EG

Egypt

EH

Western Sahara

ER

Eritrea

ES

Spain

ET

Ethiopia

FI

Finland

FJ

Fiji

FK

Falkland Islands (Malvinas)

FM

Micronesia, Federated States of

FO

Faroe Islands

FR

France

GA

Gabon

GB

United Kingdom

GD

Grenada

GE

Georgia

GF

French Guiana

GG

Guernsey

GH

Ghana

GI

Gibraltar

GL

Greenland

GM

Gambia

GN

Guinea

GP

Guadeloupe

GQ

Equatorial Guinea

GR

Greece

GS

South Georgia and the South Sandwich Islands

GT

Guatemala

GU

Guam

GY

Guyana

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EU FMD Compliant?

Yes

Yes

Yes

Yes

Yes

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Country Code

Country

HK

Hong Kong

HN

Honduras

HM

Heard Island and McDonald Islands

HN

Honduras

HR

Croatia

HT

Haiti

HU

Hungary

ID

Indonesia

IE

Ireland

IL

Israel

IM

Isle of Man

IN

India

IO

British Indian Ocean Territory

IQ

Iraq

IR

Iran, Islamic Republic of

IS

Iceland

Yes

IT

Italy

Yes

JE

Jersey

JM

Jamaica

JO

Jordan

JP

Japan

KE

Kenya

KG

Kyrgyzstan

KH

Cambodia

KM

Comoros

KN

Saint Kitts and Nevis

KP

Korea, Democratic People’s Republic of

KR

Korea, Republic of

KW

Kuwait

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EU FMD Compliant?

Yes

Yes

Yes

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Country Code

Country

KY

Cayman Islands

KZ

Kazakhstan

LA

Lao People’s Democratic Republic

LB

Lebanon

LC

Saint Lucia

LI

Liechtenstein

LK

Sri Lanka

LR

Liberia

LS

Lesotho

LT

Lithuania

Yes

LU

Luxembourg

Yes

LV

Latvia

Yes

LY

Libya

MA

Morocco

MC

Monaco

MD

Moldova, Republic of

ME

Montenegro

MF

Saint Martin (French side)

MG

Madagascar

MH

Marshall Islands

MK

Macedonia (the former Yugoslav, Republic of)

ML

Mali

MN

Myanmar

MN

Mongolia

MO

Macao

MP

Northern Mariana Islands

MQ

Martinique

MR

Mauritania

MS

Montserrat

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EU FMD Compliant?

Yes

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Country Code

Country

EU FMD Compliant?

MT

Malta

Yes

MU

Mauritius

MW

Malawi

MX

Mexico

MY

Malaysia

MZ

Mozambique

NA

Namibia

NC

New Caledonia

NE

Niger

NF

Norfolk Island

NG

Nigeria

NI

Nicaragua

NL

Netherlands

Yes

NO

Norway

Yes

NP

Nepal

NR

Nauru

NU

Niue

NZ

New Zealand

OM

Oman

PA

Panama

PE

Peru

PF

French Polynesia

PG

Papua New Guinea

PH

Philippines

PK

Pakistan

PL

Poland

PM

Saint Pierre and Miquelon

PN

Pitcairn

PR

Puerto Rico

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Yes

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Country Code

Country

PS

Palestinian Territory, Occupied

PT

Portugal

PW

Palau

PY

Paraguay

QA

Qatar

RE

Reunion

RO

Romania

RS

Serbia

RU

Russian Federation

RW

Rwanda

SA

Saudi Arabia

SB

Solomon Islands

SC

Seychelles

SD

Sudan

SE

Sweden

SG

Singapore

SH

Saint Helena, Ascension and Tristan de Cunha

SI

Slovenia

SJ

Svalbard and Jan Mayen

SK

Slovakia

SL

Sierra Leone

SM

San Marino

SN

Senegal

SQ

Somalia

SR

Suriname

SS

South Sudan

ST

Sao Tome and Principe

SV

El Salvador

SX

Sint Maarten (Dutch part)

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EU FMD Compliant?

Yes

Yes

Yes

Yes

Yes

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Country Code

Country

SY

Syrian Arab Republic

SZ

Swaziland

TC

Turks and Caicos Islands

TD

Chad

TF

French Southern Territories

TG

Togo

TH

Thailand

TJ

Tajikistan

TK

Tokelau

TL

Timor-Leste

TM

Turkmenistan

TN

Tunisia

TO

Tonga

TR

Turkey

TT

Trinidad and Tobago

TV

Tuvalu

TW

Taiwan, Province of China

TZ

Tanzania, United Republic of

UA

Ukraine

UG

Uganda

UM

United States Minor Outlying Islands

US

United States

UY

Uruguay

UZ

Uzbekistan

VA

Holy See (Vatican City State)

VC

Saint Vincent and Grenadines

VE

Venezuela, Bolivarian Republic of

VG

Virgin Islands, British

VI

Virgin Islands, U.S.

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EU FMD Compliant?

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Country Code

Country

VN

Viet Nam

VU

Vanuatu

WF

Wallis and Futuna

WS

Samoa

YE

Yemen

YT

Mayotte

ZA

South Africa

ZM

Zambia

ZW

Zimbabwe

EU FMD Compliant?

Currency Codes The following table lists the possible currency values. If uploading Master Data using a CSV file, use the three letter currency code. Currency Code Currency Name AED

United Arab Emirates dirham

AFN

Afghan afghani

ALL

Albanian lek

AMD

American dram

ANG

Netherlands Antillean guilder

AOA

Angolan kwanza

ARS

Argentine peso

AUD

Australian dollar

AWG

Aruban florin

AZN

Azerbaijani manat

BAM

Bosnia and Herzegovina convertible

BBD

Barbados dollar

BDT

Bangladeshi taka

BGN

Bulgarian lev

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Currency Code Currency Name BHD

Bahraini dinar

BIF

Burundian franc

BMD

Bermudian dollar

BND

Brunei dollar

BOB

Boliviano

BOV

Bolivian Mvdol (funds code)

BRL

Brazilian real

BSD

Bahamian dollar

BTN

Bhutanese ngultrum

BWP

Botswana pula

BYR

Belarusian ruble

BZD

Belize dollar

CAD

Canadian dollar

CDF

Congolese franc

CHE

WIR Euro (complementary currency)

CHF

Swiss franc

CHW

WIR Franc (complementary currency)

CLF

Unidad de Fomento (funds code)

CLP

Chilean peso

CNY

Chinese yuan

COP

Colombian peso

COU

Unidad de Valor Real (UVR) (funds code)

CRC

Costa Rican colon

CUC

Cuban convertible peso

CUP

Cuban peso

CVE

Cape Verde escudo

CZK

Czech koruna

DJF

Dijboutian franc

DKK

Danish krone

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Currency Code Currency Name DOP

Dominican peso

DZD

Algerian dinar

EGP

Egyptian pound

ERN

Eritrean nakfa

ETB

Ethiopian birr

EUR

Euro

FJD

Fiji dollar

FKP

Falkland Islands pound

GBP

Pound sterling

GEL

Georgian lari

GHS

Ghanaian cedi

GIP

Gibraltar pound

GMD

Gambian dalasi

GNF

Guinean franc

GTQ

Guatemalan quetzal

GYD

Guyanese dollar

HKD

Hong Kong dollar

HNL

Honduran lempira

HRK

Croatian kuna

HTG

Haitian gourde

HUF

Hungarian forint

IDR

Indonesian rupiah

ILS

Israeli new shekel

INR

Indian rupee

IQD

Iraqi dinar

IRR

Iranian rial

ISK

Icelandic krona

JMD

Jamaican dollar

JOD

Jordanian dinar

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Currency Code Currency Name JPY

Japanese yen

KES

Kenyan shilling

KGS

Kyrgyzstani som

KHR

Cambodian riel

KMF

Comoro franc

KPW

North Korean won

KRW

South Korean won

KWD

Kuwaiti dinar

KYD

Cayman Islands dollar

KZT

Kazakhstani tenge

LAK

Lao kip

LBP

Lebanese pound

LKR

Sri Lankan rupee

LRD

Liberian dollar

LSL

Lesotho loti

LYD

Libyan dinar

MAD

Moroccan dirham

MDL

Moldovan leu

MGA

Malagasy ariary

MKD

Macedonian denar

MMK

Myanmar kyat

MNT

Mongolian togrog

MOP

Macanese pataca

MRO

Mauritanian ouguiya

MUR

Mauritian rupee

MVR

Maldivian rufiyaa

MWK

Malawian kwacha

MXN

Mexican peso

MXV

Mexican Unidad de Inversion (UDI)

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Currency Code Currency Name MYR

Malaysian ringgit

MZN

Mozambican metical

NAD

Namibian dollar

NGN

Nigerian naira

NIO

Nicaraguan cordoba

NOK

Norwegian krone

NPR

Nepalese rupee

NZD

New Zealand dollar

OMR

Omani rial

PAB

Panamanian balboa

PEN

Peruvian nuevo sol

PGK

Papua New Guinean kina

PHP

Philippine peso

PKR

Pakistani rupee

PLN

Polish zloty

PYG

Paraguayan guarani

QAR

Qatar riyal

RON

Romanian leu

RSD

Serbian dinar

RUB

Russian ruble

RWF

Rwandan franc

SAR

Saudi riyal

SBD

Solomon Islands dollar

SCR

Seychelles rupee

SDG

Sudanese pound

SEK

Swedish krona/kronor

SGD

Singapore dollar

SHP

Saint Helena pound

SLL

Sierra Leonean leone

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Currency Code Currency Name SOS

Somali shilling

SRD

Surinamese dollar

SSP

South Sudanese pound

STD

Sao Tome and Principe dobra

SYP

Syrian pound

SZL

Swazi lilangeni

THB

Thai baht

TJS

Tajikistani somoni

TMT

Turkmenistani manat

TND

Tunisian dinar

TOP

Tongan pa’anga

TRY

Turkish lira

TTD

Trinidad and Tobago dolla

TWD

New Taiwan dollar

TZS

Tanzanian shilling

UAH

Ukrainian hryvnia

UGX

Ugandan shilling

USD

United States dollar

USN

United States dollar (next day)

USS

United States dollar (same day)

UYI

Uruguay Peso en Unidades

UYU

Uruguayan peso

UZS

Uzbekistan som

VEF

Venezuelan bolivar

VND

Vietnamese dong

VUV

Vanuatu vatu

WST

Samoan tala

XAF

CFA franc BEAC

XAG

Silver (one troy ounce)

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Currency Code Currency Name XAU

Gold (one troy ounce)

XBA

European Composite Unit (EURCO) (bond market unit)

XBB

European Monetary Unit (E.M.U.-6) (bond market unit)

XBC

European Unit of Account (E.U.A.-9) (bond market unit)

XBD

European Unit of Account (E.U.A.-17) (bond market unit)

XCD

East Caribbean dollar

XDR

Special drawing rights

XFU

UIC franc (special settlement)

XOF

CFA franc BCEAO

XPD

Palladium (one troy ounce)

XPF

CFO franc (franc Pacifique)

XPT

Platinum (one troy ounce)

XSU

SUCRE

XUA

ADB Unit of Account

YER

Yemeni rial

ZAR

South African rand

ZMW

Zambian kwacha

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