Pirfenidone NDC 42291-490

NDC codes

FDA NDC Directory

Product NDC (as listed)42291-490Labeler and product segments. Claims need a package NDC.

Product NDC at billing width42291-0490Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
42291-490-27	42291049027	1 BOTTLE in 1 CARTON (42291-490-27) / 270 CAPSULE in 1 BOTTLEMarketed from Oct 18, 2023

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
Labeler: AvKARE
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 212569
Marketing start: Oct 18, 2023
Listing expires: Dec 31, 2027
Other FDA classes: Pyridones (Chemical structure)
Identifiers: Product ID 42291-490_485f7793-cdba-9e5d-e063-6294a90a5674SPL ID 485f7793-cdba-9e5d-e063-6294a90a5674SPL set ID 07ff87b3-0a88-15b4-e063-6294a90a72abRxCUI 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

N442291049027 followed by a unit qualifier and the quantity

Package 42291-0490-27. 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 Jan 14, 2026.

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.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 212569

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 212569
Product	Strength	Form · route	Labeler	Product NDC
Pirfenidone	Pirfenidone 267 mg/1	CapsuleOral	Amneal Pharmaceuticals NY LLC	60219-1642
Pirfenidone	Pirfenidone 267 mg/1	CapsuleOral	Amneal Pharmaceuticals NY LLC	69238-1642