Prescription drug · ANDA
Pirfenidone NDC 71335-2984
Pirfenidone 801 mg/1 · Tablet, Coated · Oral · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71335-2984-1 | 71335298401 | 90 TABLET, COATED in 1 BOTTLE (71335-2984-1)Marketed from Oct 30, 2025 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Pirfenidone
- Generic name (nonproprietary)
- pirfenidone
- Active ingredients
- Pirfenidone — 801 mg/1
- Dosage form
- Tablet, Coated
- Route
- Oral
- Labeler
- Bryant Ranch Prepack
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 212708
- Marketing start
- Listing expires
- Other FDA classes
- Pyridones (Chemical structure)
- Identifiers
- Product ID 71335-2984_c7d17735-c06d-435d-93da-52935e61442cSPL ID c7d17735-c06d-435d-93da-52935e61442cSPL set ID bd3483bf-96e9-4d6b-a844-63bd002c48a4RxCUI 1868018UNII D7NLD2JX7U
- Pharmacologic class
- Pyridone
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N471335298401followed by a unit qualifier and the quantityPackage 71335-2984-01. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
Pirfenidone tablets are indicated for the treatment of idiopathic pulmonary fibrosis (IPF). Pirfenidone is a pyridone indicated for the treatment of idiopathic pulmonary fibrosis (IPF). (1)
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 212708
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Pirfenidone | Pirfenidone 267 mg/1 | Tablet, CoatedOral | Alembic Pharmaceuticals Inc. | 62332-479 |
| Pirfenidone | Pirfenidone 801 mg/1 | Tablet, CoatedOral | Alembic Pharmaceuticals Inc. | 62332-480 |
| Pirfenidone | Pirfenidone 801 mg/1 | Tablet, CoatedOral | Alembic Pharmaceuticals Limited | 46708-480 |
| Pirfenidone | Pirfenidone 267 mg/1 | Tablet, CoatedOral | Alembic Pharmaceuticals Limited | 46708-479 |
| Pirfenidone | Pirfenidone 267 mg/1 | Tablet, CoatedOral | Bryant Ranch Prepack | 72162-2465 |
| Pirfenidone | Pirfenidone 801 mg/1 | Tablet, CoatedOral | Bryant Ranch Prepack | 72162-2466 |
| Pirfenidone | Pirfenidone 267 mg/1 | Tablet, CoatedOral | Bryant Ranch Prepack | 71335-2944 |