🇺🇸
United States · US · US:42385-923_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 · 3
- ndc114238592329270 CAPSULE in 1 BOTTLE (42385-923-29)
- ndc1142385923544 BLISTER PACK in 1 CARTON (42385-923-54) / 63 CAPSULE in 1 BLISTER PACK
- ndc1142385923632 BLISTER PACK in 1 CARTON (42385-923-63) / 21 BLISTER PACK in 1 BLISTER PACK / 42 CAPSULE in 1 BLISTER PACK
Annotations
UNII (FDA Substance ID)
D7NLD2JX7U
PIRFENIDONE
RxCUI 1592254
Orange Book
A212724
AB
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": "42385-923_487408e2-1370-400a-a513-8de1d662defa",
"productndc": "42385-923",
"dosage_form": "CAPSULE",
"orange_book": {
"appl_no": "212724",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "267MG",
"product_no": "001",
"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": "ANDA212724",
"marketing_category": "ANDA",
"nonproprietary_name": "Pirfenidone",
"start_marketing_date": "20220719",
"active_numerator_strength": "267"
}Related drugs
Other records sharing ATC code L04AX05.
Access this data programmatically
Query Pirfenidone and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.