Prescription drug · ANDA
Pirfenidone NDC 51407-914
Pirfenidone 801 mg/1 · Tablet · Oral · Golden State Medical Supply, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 51407-914-90 | 51407091490 | 90 TABLET in 1 BOTTLE (51407-914-90)Marketed from Apr 30, 2024 |
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
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 212709
- Marketing start
- Listing expires
- Other FDA classes
- Pyridones (Chemical structure)
- Identifiers
- Product ID 51407-914_445b8f7f-9ec4-5f1d-e063-6394a90a098bSPL ID 445b8f7f-9ec4-5f1d-e063-6394a90a098bSPL set ID 1b3261fe-c066-6e86-e063-6294a90a675cRxCUI 1868014, 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
N451407091490followed by a unit qualifier and the quantityPackage 51407-0914-90. 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 tablets are 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 212709
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 | TabletOral | Golden State Medical Supply, Inc. | 51407-913 |
| Pirfenidone | Pirfenidone 801 mg/1 | TabletOral | Apotex Corp. | 60505-4682 |
| Pirfenidone | Pirfenidone 267 mg/1 | TabletOral | Apotex Corp. | 60505-4681 |