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United States · US · US:59651-238_50958060-c904-4374-997d-59df54007fa4
Pirfenidone
Orange BookUNIISPLATC L04AX05
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAurobindo Pharma Limited
CountryUS (United States)
ATC codeL04AX05
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1159651238273 BOTTLE in 1 CARTON (59651-238-27) / 90 TABLET in 1 BOTTLE (59651-238-90)
Annotations
UNII (FDA Substance ID)
D7NLD2JX7U
PIRFENIDONE
RxCUI 1592254
Orange Book
A212596
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": "59651-238_50958060-c904-4374-997d-59df54007fa4",
"productndc": "59651-238",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "212596",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "267MG",
"product_no": "001",
"approval_date": "Aug 11, 2025"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "801MG",
"product_no": "002",
"approval_date": "Aug 11, 2025"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "PIRFENIDONE",
"proprietary_name": "Pirfenidone",
"active_ingred_unit": "mg/1",
"application_number": "ANDA212596",
"marketing_category": "ANDA",
"nonproprietary_name": "Pirfenidone",
"start_marketing_date": "20250811",
"active_numerator_strength": "267"
}Related drugs
Other records sharing ATC code L04AX05.
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