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United States · US · US:50228-442_09af4fec-e2cf-2c8d-e063-6294a90af999
PIRFENIDONE
Orange BookUNIISPLATC L04AX05
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerScieGen Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeL04AX05
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc1150228442101000 TABLET in 1 BOTTLE (50228-442-10)
- ndc11502284423030 TABLET in 1 BOTTLE (50228-442-30)
Annotations
UNII (FDA Substance ID)
D7NLD2JX7U
PIRFENIDONE
RxCUI 1592254
Orange Book
A212078
ABAB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "D7NLD2JX7U",
"rxcui": "1592254",
"inchikey": "ISWRGOKTTBVCFA-UHFFFAOYSA-N",
"display_name": "PIRFENIDONE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"3115f15f-171c-4266-8dc8-5655f56e6acc": {
"match": "brand_token",
"title": "PIRFENIDONE CAPSULE [AUROBINDO PHARMA LIMITED]",
"spl_version": "1",
"published_date": "2026-04-29"
}
},
"productid": "50228-442_09af4fec-e2cf-2c8d-e063-6294a90af999",
"productndc": "50228-442",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "212078",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "267MG",
"product_no": "001",
"approval_date": "Aug 1, 2022"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "801MG",
"product_no": "002",
"approval_date": "Aug 1, 2022"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "PIRFENIDONE",
"proprietary_name": "PIRFENIDONE",
"active_ingred_unit": "mg/1",
"application_number": "ANDA212078",
"marketing_category": "ANDA",
"nonproprietary_name": "PIRFENIDONE",
"start_marketing_date": "20220801",
"active_numerator_strength": "267"
}Related drugs
Other records sharing ATC code L04AX05.
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