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United States · US · US:68071-3763_2b5ca657-3fa5-8704-e063-6394a90a9f26
Leflunomide
Orange BookUNIISPLATC L04AK01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerNuCare Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeL04AK01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1168071376391 BOTTLE in 1 CARTON (68071-3763-9) / 90 TABLET, FILM COATED in 1 BOTTLE
Annotations
UNII (FDA Substance ID)
G162GK9U4W
LEFLUNOMIDE
RxCUI 27169
Orange Book
A211863
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": "68071-3763_2b5ca657-3fa5-8704-e063-6394a90a9f26",
"productndc": "68071-3763",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "211863",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "10MG",
"product_no": "001",
"approval_date": "Feb 4, 2020"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "20MG",
"product_no": "002",
"approval_date": "Feb 4, 2020"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "LEFLUNOMIDE",
"proprietary_name": "Leflunomide",
"active_ingred_unit": "mg/1",
"application_number": "ANDA211863",
"marketing_category": "ANDA",
"nonproprietary_name": "Leflunomide",
"start_marketing_date": "20200831",
"active_numerator_strength": "10"
}Related drugs
Other records sharing ATC code L04AK01.
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