Prescription drug · ANDA
Pirfenidone NDC 72603-259
Pirfenidone 801 mg/1 · Tablet, Film coated · Oral · Northstar Rx LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72603-259-01 | 72603025901 | 90 TABLET, FILM COATED in 1 BOTTLE (72603-259-01)Marketed from Jul 1, 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, Film coated
- Route
- Oral
- Labeler
- Northstar Rx LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 212772
- Marketing start
- Listing expires
- Other FDA classes
- Pyridones (Chemical structure)
- Identifiers
- Product ID 72603-259_5d0eee8c-dc7d-4444-8684-e9c9335291c8SPL ID 5d0eee8c-dc7d-4444-8684-e9c9335291c8SPL set ID 5d0eee8c-dc7d-4444-8684-e9c9335291c8RxCUI 1868014, 1868018UNII D7NLD2JX7UUPC 0372603259018, 0372603258011
- 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
N472603025901followed by a unit qualifier and the quantityPackage 72603-0259-01. 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 tablet is indicated for the treatment of idiopathic pulmonary fibrosis (IPF). Pirfenidone tablet 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 212772
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, Film coatedOral | Novadoz Pharmaceuticals LLC | 72205-181 |
| Pirfenidone | Pirfenidone 801 mg/1 | Tablet, Film coatedOral | Novadoz Pharmaceuticals LLC | 72205-182 |
| Pirfenidone | Pirfenidone 267 mg/1 | Tablet, Film coatedOral | MAJOR PHARMACEUTICALS | 0904-7397 |
| Pirfenidone | Pirfenidone 801 mg/1 | Tablet, Film coatedOral | MAJOR PHARMACEUTICALS | 0904-7398 |
| Pirfenidone | Pirfenidone 267 mg/1 | Tablet, Film coatedOral | Northstar Rx LLC | 72603-258 |