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United States · US · US:70771-1491_e96c4125-a2bf-420c-8ffe-6d7ddb7dd645
leflunomide
Orange BookUNIISPLATC L04AK01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerZydus Lifesciences Limited
CountryUS (United States)
ATC codeL04AK01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc117077114911100 TABLET, FILM COATED in 1 BOTTLE (70771-1491-1)
- ndc11707711491330 TABLET, FILM COATED in 1 BOTTLE (70771-1491-3)
- ndc117077114915500 TABLET, FILM COATED in 1 BOTTLE (70771-1491-5)
Annotations
UNII (FDA Substance ID)
G162GK9U4W
LEFLUNOMIDE
RxCUI 27169
Orange Book
A212308
ABAB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "G162GK9U4W",
"rxcui": "27169",
"inchikey": "VHOGYURTWQBHIL-UHFFFAOYSA-N",
"display_name": "LEFLUNOMIDE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"e76d7767-744f-4e52-956d-e59f7a924826": {
"match": "brand_token",
"title": "LEFLUNOMIDE TABLET [BRYANT RANCH PREPACK]",
"spl_version": "102",
"published_date": "2026-03-18"
}
},
"productid": "70771-1491_e96c4125-a2bf-420c-8ffe-6d7ddb7dd645",
"productndc": "70771-1491",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "212308",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "10MG",
"product_no": "001",
"approval_date": "Apr 24, 2019"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "20MG",
"product_no": "002",
"approval_date": "Apr 24, 2019"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "LEFLUNOMIDE",
"proprietary_name": "leflunomide",
"active_ingred_unit": "mg/1",
"application_number": "ANDA212308",
"marketing_category": "ANDA",
"nonproprietary_name": "leflunomide",
"start_marketing_date": "20190426",
"active_numerator_strength": "10"
}Related drugs
Other records sharing ATC code L04AK01.
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