Prescription drug · ANDA
Pirfenidone NDC 76282-716
Pirfenidone 801 mg/1 · Tablet, Coated · Oral · EXELAN PHARMACEUTICALS INC.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 76282-716-27 | 76282071627 | 270 TABLET, COATED in 1 BOTTLE (76282-716-27)Marketed from Aug 2, 2022 | |
| 76282-716-90 | 76282071690 | 90 TABLET, COATED in 1 BOTTLE (76282-716-90)Marketed from Aug 2, 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
- EXELAN PHARMACEUTICALS INC.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 212078
- Marketing start
- Listing expires
- Other FDA classes
- Pyridones (Chemical structure)
- Identifiers
- Product ID 76282-716_3449172d-fe07-4924-ad05-89b854600aebSPL ID 3449172d-fe07-4924-ad05-89b854600aebSPL set ID c171e4af-1619-4712-958f-ef96adfede37RxCUI 1868014, 1868018UNII D7NLD2JX7UUPC 0376282717272, 0376282716909, 0376282716275, 0376282717906
- 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
N476282071627followed by a unit qualifier and the quantityPackage 76282-0716-27. 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 is 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 212078
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 | Cipla USA Inc. | 69097-987 |
| Pirfenidone | Pirfenidone 801 mg/1 | Tablet, CoatedOral | Cipla USA Inc. | 69097-988 |
| Pirfenidone | Pirfenidone 267 mg/1 | Tablet, CoatedOral | EXELAN PHARMACEUTICALS INC. | 76282-717 |
| Pirfenidone | Pirfenidone 267 mg/1 | TabletOral | ScieGen Pharmaceuticals, Inc. | 50228-442 |
| Pirfenidone | Pirfenidone 801 mg/1 | TabletOral | ScieGen Pharmaceuticals, Inc. | 50228-443 |