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Alternate items available Phase out Items no longer stocked Withdrawn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
Copyright © 2018 TraceLink
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
Copyright © 2018 TraceLink
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
Copyright © 2018 TraceLink
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
Copyright © 2018 TraceLink
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
Copyright © 2018 TraceLink
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
Copyright © 2018 TraceLink
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
Copyright © 2018 TraceLink
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)
Copyright © 2018 TraceLink
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)
Copyright © 2018 TraceLink
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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
Copyright © 2018 TraceLink
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