Prescription drug · ANDA
Pirfenidone NDC 31722-873
Pirfenidone 801 mg/1 · Tablet, Film coated · Oral · Camber Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 31722-873-90 | 31722087390 | 90 TABLET, FILM COATED in 1 BOTTLE (31722-873-90)Marketed from Sep 21, 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, Film coated
- Route
- Oral
- Labeler
- Camber Pharmaceuticals, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 212674
- Marketing start
- Listing expires
- Other FDA classes
- Pyridones (Chemical structure)
- Identifiers
- Product ID 31722-873_fb680aba-6d5a-2676-e053-6294a90a467fSPL ID fb680aba-6d5a-2676-e053-6294a90a467fSPL set ID a7f3485e-9dcc-45db-9b9c-74c70e22c4bbRxCUI 1868014, 1868018UNII D7NLD2JX7UUPC 0331722872270, 0331722873901
- 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
N431722087390followed by a unit qualifier and the quantityPackage 31722-0873-90. 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 212674
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 | Camber Pharmaceuticals, Inc. | 31722-872 |