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United States · US · US:33342-461_3e8acd31-bbc7-48d5-956d-6cb04cbdc96c
Pirfenidone Capsule, 267 mg
Orange BookUNIISPLATC L04AX05
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerMacleods Pharmaceuticals Limited
CountryUS (United States)
ATC codeL04AX05
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc1133342461381 BLISTER PACK in 1 CARTON (33342-461-38) / 63 CAPSULE in 1 BLISTER PACK
- ndc113334246158270 CAPSULE in 1 BOTTLE (33342-461-58)
- ndc1133342461821 BLISTER PACK in 1 CARTON (33342-461-82) / 252 CAPSULE in 1 BLISTER PACK
Annotations
UNII (FDA Substance ID)
D7NLD2JX7U
PIRFENIDONE
RxCUI 1592254
Orange Book
A212748
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": "33342-461_3e8acd31-bbc7-48d5-956d-6cb04cbdc96c",
"productndc": "33342-461",
"dosage_form": "CAPSULE",
"orange_book": {
"appl_no": "212748",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "267MG",
"product_no": "001",
"approval_date": "Dec 18, 2024"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "PIRFENIDONE",
"proprietary_name": "Pirfenidone Capsule, 267 mg",
"active_ingred_unit": "mg/1",
"application_number": "ANDA212748",
"marketing_category": "ANDA",
"nonproprietary_name": "Pirfenidone Capsule, 267 mg",
"start_marketing_date": "20200720",
"active_numerator_strength": "267"
}Related drugs
Other records sharing ATC code L04AX05.
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