Prescription drug · ANDA
Pirfenidone NDC 69238-1642
Pirfenidone 267 mg/1 · Capsule · Oral · Amneal Pharmaceuticals NY LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 69238-1642-7 | 69238164207 | 1 BOTTLE in 1 CARTON (69238-1642-7) / 270 CAPSULE in 1 BOTTLEMarketed from Jan 7, 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 — 267 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 212569
- Marketing start
- Listing expires
- Other FDA classes
- Pyridones (Chemical structure)
- Identifiers
- Product ID 69238-1642_d7214722-7cee-4a8a-9b9e-8955333a1146SPL ID d7214722-7cee-4a8a-9b9e-8955333a1146SPL set ID ea26490e-fd32-4807-8556-eb6f5f963c23RxCUI 1592279UNII 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
N469238164207followed by a unit qualifier and the quantityPackage 69238-1642-07. 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 capsules are 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 212569
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 | CapsuleOral | AvKARE | 42291-490 |
| Pirfenidone | Pirfenidone 267 mg/1 | CapsuleOral | Amneal Pharmaceuticals NY LLC | 60219-1642 |