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NDC 00781-2158-32 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 Sandoz Inc. The primary component is PIRFENIDONE.
Product Information
| NDC | 00781-2158 |
|---|---|
| Product ID | 0781-2158_32529e77-3c54-4bee-ab7b-086e73d6a9af |
| 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 | Sandoz Inc |
| Pharmaceutical Class | Pyridone [EPC], Pyridones [CS] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA212600 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 00781-2158-32 (00781215832)
| NDC Package Code | 0781-2158-32 |
|---|---|
| Billing NDC | 00781215832 |
| Package | 270 CAPSULE in 1 BOTTLE, PLASTIC (0781-2158-32) |
| Marketing Start Date | 2023-01-09 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |