Prescription drug · ANDA
Pirfenidone NDC 50228-441
Pirfenidone 267 mg/1 · Capsule · Oral · ScieGen Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50228-441-05 | 50228044105 | 500 CAPSULE in 1 BOTTLE (50228-441-05)Marketed from Aug 1, 2022 | |
| 50228-441-30 | 50228044130 | 30 CAPSULE in 1 BOTTLE (50228-441-30)Marketed from Aug 1, 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 — 267 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 212077
- Marketing start
- Listing expires
- Other FDA classes
- Pyridones (Chemical structure)
- Identifiers
- Product ID 50228-441_09c07f37-fe44-f211-e063-6394a90aae02SPL ID 09c07f37-fe44-f211-e063-6394a90aae02SPL set ID 1fbdb556-b164-4e0b-a95e-6004d50e3364RxCUI 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
N450228044105followed by a unit qualifier and the quantityPackage 50228-0441-05. 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 212077
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 | EXELAN PHARMACEUTICALS INC. | 76282-715 |
| Pirfenidone | Pirfenidone 267 mg/1 | CapsuleOral | Cipla USA Inc. | 69097-940 |