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United States · US · US:46708-479_5dd2966d-35b0-4a80-a677-bca6f4c69311
Pirfenidone
Orange BookUNIISPLATC L04AX05
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAlembic Pharmaceuticals Limited
CountryUS (United States)
ATC codeL04AX05
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc114670847927270 TABLET, COATED in 1 BOTTLE (46708-479-27)
- ndc1146708479643 BOTTLE in 1 CARTON (46708-479-64) / 90 TABLET, COATED in 1 BOTTLE
- ndc114670847971500 TABLET, COATED in 1 BOTTLE (46708-479-71)
Annotations
UNII (FDA Substance ID)
D7NLD2JX7U
PIRFENIDONE
RxCUI 1592254
Orange Book
A212708
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": "46708-479_5dd2966d-35b0-4a80-a677-bca6f4c69311",
"productndc": "46708-479",
"dosage_form": "TABLET, COATED",
"orange_book": {
"appl_no": "212708",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "267MG",
"product_no": "001",
"approval_date": "May 20, 2022"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "801MG",
"product_no": "002",
"approval_date": "May 20, 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": "ANDA212708",
"marketing_category": "ANDA",
"nonproprietary_name": "Pirfenidone",
"start_marketing_date": "20220610",
"active_numerator_strength": "267"
}Related drugs
Other records sharing ATC code L04AX05.
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