Pirfenidone NDC 42571-335

NDC codes

FDA NDC Directory

Product NDC (as listed)42571-335Labeler and product segments. Claims need a package NDC.

Product NDC at billing width42571-0335Add 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
42571-335-39	42571033539	3 TABLET, FILM COATED in 1 CARTON (42571-335-39)Marketed from Dec 1, 2022
42571-335-90	42571033590	90 BOTTLE in 1 CARTON (42571-335-90) / 90 TABLET, FILM COATED in 1 BOTTLEMarketed from Dec 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: Tablet, Film coated
Route: Oral
Labeler: Micro Labs Limited
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 212680
Marketing start: Dec 1, 2022
Listing expires: Dec 31, 2026
Other FDA classes: Pyridones (Chemical structure)
Identifiers: Product ID 42571-335_36ba36c4-7b9d-e62c-e063-6394a90acdabSPL ID 36ba36c4-7b9d-e62c-e063-6394a90acdabSPL set ID 1abc06c7-6a45-4a0b-b2da-c228aaa137edRxCUI 1868014, 1868018UNII D7NLD2JX7UUPC 0342571335908, 0342571336905, 0342571335397
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

N442571033539 followed by a unit qualifier and the quantity

Package 42571-0335-39. 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 Jun 4, 2025.

Indications (excerpt from the label)

Pirfenidone tablet is indicated for the treatment of idiopathic pulmonary fibrosis (IPF). Pirfenidone tablet 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 212680

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

FDA NDC Directory listings under ANDA 212680
Product	Strength	Form · route	Labeler	Product NDC
Pirfenidone	Pirfenidone 801 mg/1	Tablet, Film coatedOral	Micro Labs Limited	42571-336