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United States · US · US:72603-258_5d0eee8c-dc7d-4444-8684-e9c9335291c8
PIRFENIDONE
Orange BookUNIISPLATC L04AX05
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerNorthstar Rx LLC
CountryUS (United States)
ATC codeL04AX05
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1172603258033 BOTTLE in 1 CARTON (72603-258-03) / 90 TABLET, FILM COATED in 1 BOTTLE (72603-258-01)
Annotations
UNII (FDA Substance ID)
D7NLD2JX7U
PIRFENIDONE
RxCUI 1592254
Orange Book
A212772
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": "72603-258_5d0eee8c-dc7d-4444-8684-e9c9335291c8",
"productndc": "72603-258",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "212772",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "267MG",
"product_no": "001",
"approval_date": "May 24, 2022"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "801MG",
"product_no": "002",
"approval_date": "May 24, 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": "ANDA212772",
"marketing_category": "ANDA",
"nonproprietary_name": "PIRFENIDONE",
"start_marketing_date": "20220524",
"active_numerator_strength": "267"
}Related drugs
Other records sharing ATC code L04AX05.
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