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United States · US · US:50268-477_47e6f1e5-f12c-c5d1-e063-6294a90a78b2
LEFLUNOMIDE
Orange BookUNIISPLATC L04AK01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAvPAK
CountryUS (United States)
ATC codeL04AK01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11502684771550 BLISTER PACK in 1 BOX (50268-477-15) / 1 TABLET in 1 BLISTER PACK (50268-477-11)
Annotations
UNII (FDA Substance ID)
G162GK9U4W
LEFLUNOMIDE
RxCUI 27169
Orange Book
A077090
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": "50268-477_47e6f1e5-f12c-c5d1-e063-6294a90a78b2",
"productndc": "50268-477",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "077090",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "10MG",
"product_no": "001",
"approval_date": "Sep 13, 2005"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "20MG",
"product_no": "002",
"approval_date": "Sep 13, 2005"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "LEFLUNOMIDE",
"proprietary_name": "LEFLUNOMIDE",
"active_ingred_unit": "mg/1",
"application_number": "ANDA077090",
"marketing_category": "ANDA",
"nonproprietary_name": "LEFLUNOMIDE",
"start_marketing_date": "20200917",
"active_numerator_strength": "10"
}Related drugs
Other records sharing ATC code L04AK01.
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