Prescription drug · ANDA
Pirfenidone NDC 62332-480
Pirfenidone 801 mg/1 · Tablet, Coated · Oral · Alembic Pharmaceuticals Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 62332-480-71 | 62332048071 | 500 TABLET, COATED in 1 BOTTLE (62332-480-71)Marketed from Jun 10, 2022 | |
| 62332-480-90 | 62332048090 | 90 TABLET, COATED in 1 BOTTLE (62332-480-90)Marketed from Jun 10, 2022 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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
- Alembic Pharmaceuticals Inc.
- 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 62332-480_9f41a23e-cc34-4b25-871d-deeef997fe8dSPL ID 9f41a23e-cc34-4b25-871d-deeef997fe8dSPL set ID 9214862e-9ef7-4370-856a-f5697978270aRxCUI 1868014, 1868018UNII D7NLD2JX7UUPC 0362332479719
- 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
N462332048071followed by a unit qualifier and the quantityPackage 62332-0480-71. 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 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 |
| Pirfenidone | Pirfenidone 801 mg/1 | Tablet, CoatedOral | Bryant Ranch Prepack | 71335-2984 |