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United States · US · US:54766-590_431426e8-80d4-a4e2-e063-6394a90af918
IMURAN
Orange BookUNIISPLATC L04AX01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerSebela Pharmaceuticals Inc.
CountryUS (United States)
ATC codeL04AX01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc115476659010100 TABLET in 1 BOTTLE (54766-590-10)
Annotations
UNII (FDA Substance ID)
MRK240IY2L
AZATHIOPRINE
RxCUI 1256
Orange Book
N016324
AB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "MRK240IY2L",
"rxcui": "1256",
"inchikey": "LMEKQMALGUDUQG-UHFFFAOYSA-N",
"display_name": "AZATHIOPRINE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"606101a0-6244-7eff-e053-2a91aa0acadd": {
"match": "brand_token",
"title": "IMURAN (AZATHIOPRINE) TABLET [SEBELA PHARMACEUTICALS INC.]",
"spl_version": "6",
"published_date": "2025-11-17"
}
},
"productid": "54766-590_431426e8-80d4-a4e2-e063-6394a90af918",
"productndc": "54766-590",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "016324",
"products": [
{
"rs": true,
"rld": true,
"te_code": "AB",
"strength": "50MG",
"product_no": "001",
"approval_date": "Approved Prior to Jan 1, 1982"
},
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",
"product_no": "002",
"approval_date": "Approved Prior to Jan 1, 1982"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "AZATHIOPRINE",
"proprietary_name": "IMURAN",
"active_ingred_unit": "mg/1",
"application_number": "NDA016324",
"marketing_category": "NDA",
"nonproprietary_name": "azathioprine",
"start_marketing_date": "20171201",
"active_numerator_strength": "50"
}Related drugs
Other records sharing ATC code L04AX01.
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