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United States · US · US:62332-061_44a1c7ce-ff50-43a8-8593-a0f506eca838
Leflunomide
Orange BookUNIISPLATC L04AK01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAlembic Pharmaceuticals Inc.
CountryUS (United States)
ATC codeL04AK01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 4
- ndc11623320613030 TABLET in 1 BOTTLE (62332-061-30)
- ndc116233206131100 TABLET in 1 BOTTLE (62332-061-31)
- ndc11623320616060 TABLET in 1 BOTTLE (62332-061-60)
- ndc116233206171500 TABLET in 1 BOTTLE (62332-061-71)
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": "62332-061_44a1c7ce-ff50-43a8-8593-a0f506eca838",
"productndc": "62332-061",
"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": "10"
}Related drugs
Other records sharing ATC code L04AK01.
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