Search by Drug Name or NDC
NDC 42385-0923-54 Pirfenidone 267 mg/1 Details
Pirfenidone 267 mg/1
Pirfenidone is a ORAL CAPSULE in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Laurus Labs Limited. 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: 42385-0923-54Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Pirfenidone
Product Information
| NDC | 42385-0923 |
|---|---|
| Product ID | 42385-923_cf17d5b2-c169-4671-a819-803409d48b1a |
| Associated GPIs | |
| GCN Sequence Number | 070889 |
| GCN Sequence Number Description | pirfenidone CAPSULE 267 MG ORAL |
| HIC3 | Z1M |
| HIC3 Description | ANTIFIBROTIC THERAPY - PYRIDONE ANALOGS |
| GCN | 34553 |
| 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 | CAPSULE |
| Route | ORAL |
| Active Ingredient Strength | 267 |
| Active Ingredient Units | mg/1 |
| Substance Name | PIRFENIDONE |
| Labeler Name | Laurus Labs Limited |
| Pharmaceutical Class | Pyridone [EPC], Pyridones [CS] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA212724 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 42385-0923-54 (42385092354)
| NDC Package Code | 42385-923-54 |
|---|---|
| Billing NDC | 42385092354 |
| Package | 4 BLISTER PACK in 1 CARTON (42385-923-54) / 63 CAPSULE in 1 BLISTER PACK |
| Marketing Start Date | 2022-07-19 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |