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United States · US · US:46708-437_aa5c1860-7668-433b-bc17-c6de2b772e0f
Leflunomide
Orange BookUNIISPLATC L04AK01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAlembic Pharmaceuticals Limited
CountryUS (United States)
ATC codeL04AK01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 4
- ndc11467084373030 TABLET in 1 BOTTLE (46708-437-30)
- ndc114670843731100 TABLET in 1 BOTTLE (46708-437-31)
- ndc11467084376060 TABLET in 1 BOTTLE (46708-437-60)
- ndc114670843771500 TABLET in 1 BOTTLE (46708-437-71)
Annotations
UNII (FDA Substance ID)
G162GK9U4W
LEFLUNOMIDE
RxCUI 27169
Orange Book
A091369
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": "46708-437_aa5c1860-7668-433b-bc17-c6de2b772e0f",
"productndc": "46708-437",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "091369",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "10MG",
"product_no": "001",
"approval_date": "Nov 21, 2011"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "20MG",
"product_no": "002",
"approval_date": "Nov 21, 2011"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "LEFLUNOMIDE",
"proprietary_name": "Leflunomide",
"active_ingred_unit": "mg/1",
"application_number": "ANDA091369",
"marketing_category": "ANDA",
"nonproprietary_name": "Leflunomide",
"start_marketing_date": "20161201",
"active_numerator_strength": "20"
}Related drugs
Other records sharing ATC code L04AK01.
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