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United States · US · US:60219-1641_0d60ec15-427d-43a3-87f0-d83c33221fe1
Pirfenidone
Orange BookUNIISPLATC L04AX05
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAmneal Pharmaceuticals NY LLC
CountryUS (United States)
ATC codeL04AX05
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1160219164191 BOTTLE, PLASTIC in 1 CARTON (60219-1641-9) / 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
Annotations
UNII (FDA Substance ID)
D7NLD2JX7U
PIRFENIDONE
RxCUI 1592254
Orange Book
A212570
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": "60219-1641_0d60ec15-427d-43a3-87f0-d83c33221fe1",
"productndc": "60219-1641",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "212570",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "267MG",
"product_no": "001",
"approval_date": "Mar 25, 2022"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "801MG",
"product_no": "002",
"approval_date": "Mar 25, 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": "ANDA212570",
"marketing_category": "ANDA",
"nonproprietary_name": "Pirfenidone",
"start_marketing_date": "20220329",
"active_numerator_strength": "801"
}Related drugs
Other records sharing ATC code L04AX05.
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