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NDC 42291-0492-09 Pirfenidone 801 mg/1 Details
Pirfenidone 801 mg/1
Pirfenidone is a ORAL TABLET, FILM COATED in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by AvKARE. The primary component is PIRFENIDONE.
MedlinePlus Drug Summary
Pirfenidone is used for the treatment of idiopathic pulmonary fibrosis (scarring of the lungs with an unknown cause). Pirfenidone is in a class of medications called pyridones. It works by blocking the action of a certain natural substance in the body that is involved in causing fibrosis.
Related Packages: 42291-0492-09Last Updated: 04/07/2024
MedLinePlus Full Drug Details: Pirfenidone
Product Information
| NDC | 42291-0492 |
|---|---|
| Product ID | 42291-492_080468d8-d76a-42a9-e063-6394a90a5353 |
| Associated GPIs | |
| GCN Sequence Number | 077034 |
| GCN Sequence Number Description | pirfenidone TABLET 801 MG ORAL |
| HIC3 | Z1M |
| HIC3 Description | ANTIFIBROTIC THERAPY - PYRIDONE ANALOGS |
| GCN | 42905 |
| HICL Sequence Number | 040237 |
| HICL Sequence Number Description | PIRFENIDONE |
| Brand/Generic | Generic |
| Proprietary Name | Pirfenidone |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Pirfenidone |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | TABLET, FILM COATED |
| Route | ORAL |
| Active Ingredient Strength | 801 |
| Active Ingredient Units | mg/1 |
| Substance Name | PIRFENIDONE |
| Labeler Name | AvKARE |
| Pharmaceutical Class | Pyridone [EPC], Pyridones [CS] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA212570 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 42291-0492-09 (42291049209)
| NDC Package Code | 42291-492-09 |
|---|---|
| Billing NDC | 42291049209 |
| Package | 1 BOTTLE in 1 CARTON (42291-492-09) / 90 TABLET, FILM COATED in 1 BOTTLE |
| Marketing Start Date | 2023-10-18 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |