Prescription drug · ANDA
Pirfenidone NDC 60219-1641
Pirfenidone 801 mg/1 · Tablet, Film coated · Oral · Amneal Pharmaceuticals NY LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 60219-1641-9 | 60219164109 | 1 BOTTLE, PLASTIC in 1 CARTON (60219-1641-9) / 90 TABLET, FILM COATED in 1 BOTTLE, PLASTICMarketed from Mar 29, 2022 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 212570
- Marketing start
- Listing expires
- Other FDA classes
- Pyridones (Chemical structure)
- Identifiers
- Product ID 60219-1641_0d60ec15-427d-43a3-87f0-d83c33221fe1SPL ID 0d60ec15-427d-43a3-87f0-d83c33221fe1SPL set ID 94362a07-7c64-42ce-adef-f49585af55d6RxCUI 1868014, 1868018UNII D7NLD2JX7UUPC 0360219164192, 0360219164086
- 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
N460219164109followed by a unit qualifier and the quantityPackage 60219-1641-09. 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
Label details couldn’t be retrieved right now. Open the label on DailyMed.
Other NDCs under ANDA 212570
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 | Amneal Pharmaceuticals NY LLC | 60219-1640 |
| Pirfenidone | Pirfenidone 267 mg/1 | Tablet, Film coatedOral | AvKARE | 42291-491 |
| Pirfenidone | Pirfenidone 801 mg/1 | Tablet, Film coatedOral | AvKARE | 42291-492 |
| Pirfenidone | Pirfenidone 267 mg/1 | Tablet, Film coatedOral | Amneal Pharmaceuticals NY LLC | 69238-1640 |
| Pirfenidone | Pirfenidone 801 mg/1 | Tablet, Film coatedOral | Amneal Pharmaceuticals NY LLC | 69238-1641 |