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United States · US · US:10702-277_3843c448-c1bf-a403-e063-6394a90a3e77
Leflunomide
Orange BookUNIISPLATC L04AK01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerKVK-Tech, Inc.
CountryUS (United States)
ATC codeL04AK01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11107022770330 TABLET in 1 BOTTLE (10702-277-03)
Annotations
UNII (FDA Substance ID)
G162GK9U4W
LEFLUNOMIDE
RxCUI 27169
Orange Book
A212453
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": "10702-277_3843c448-c1bf-a403-e063-6394a90a3e77",
"productndc": "10702-277",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "212453",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "10MG",
"product_no": "001",
"approval_date": "Jun 3, 2019"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "20MG",
"product_no": "002",
"approval_date": "Jun 3, 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": "ANDA212453",
"marketing_category": "ANDA",
"nonproprietary_name": "Leflunomide",
"start_marketing_date": "20200723",
"active_numerator_strength": "10"
}Related drugs
Other records sharing ATC code L04AK01.
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