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United States · US · US:42385-925_487408e2-1370-400a-a513-8de1d662defa
Pirfenidone
Orange BookUNIISPLATC L04AX05
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerLaurus Labs Limited
CountryUS (United States)
ATC codeL04AX05
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11423859259090 TABLET, FILM COATED in 1 BOTTLE (42385-925-90)
Annotations
UNII (FDA Substance ID)
D7NLD2JX7U
PIRFENIDONE
RxCUI 1592254
Orange Book
A212722
ABABAB
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": "42385-925_487408e2-1370-400a-a513-8de1d662defa",
"productndc": "42385-925",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "212722",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "267MG",
"product_no": "001",
"approval_date": "Jul 19, 2022"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "534MG",
"product_no": "002",
"approval_date": "Jul 19, 2022"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "801MG",
"product_no": "003",
"approval_date": "Jul 19, 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": "ANDA212722",
"marketing_category": "ANDA",
"nonproprietary_name": "Pirfenidone",
"start_marketing_date": "20220719",
"active_numerator_strength": "534"
}Related drugs
Other records sharing ATC code L04AX05.
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