Pirfenidone NDC 42385-925

NDC codes

FDA NDC Directory

Product NDC (as listed)42385-925Labeler and product segments. Claims need a package NDC.

Product NDC at billing width42385-0925Add 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
42385-925-90	42385092590	90 TABLET, FILM COATED in 1 BOTTLE (42385-925-90)Marketed from Jul 19, 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 — 534 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: Laurus Labs Limited
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 212722
Marketing start: Jul 19, 2022
Listing expires: Dec 31, 2026
Other FDA classes: Pyridones (Chemical structure)
Identifiers: Product ID 42385-925_487408e2-1370-400a-a513-8de1d662defaSPL ID 487408e2-1370-400a-a513-8de1d662defaSPL set ID 29b0fd0e-5a2b-4da7-8524-177dc28bf55eRxCUI 1592279, 1868014, 1868018, 2606490, 2606491UNII D7NLD2JX7UUPC 0342385923292
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

N442385092590 followed by a unit qualifier and the quantity

Package 42385-0925-90. 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 Jul 22, 2025.

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.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 212722

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

FDA NDC Directory listings under ANDA 212722
Product	Strength	Form · route	Labeler	Product NDC
Pirfenidone	Pirfenidone 267 mg/1	Tablet, Film coatedOral	ANI Pharmaceuticals, Inc.	70954-869
Pirfenidone	Pirfenidone 801 mg/1	Tablet, Film coatedOral	ANI Pharmaceuticals, Inc.	70954-870
Pirfenidone	Pirfenidone 801 mg/1	Tablet, Film coatedOral	Laurus Labs Limited	42385-926
Pirfenidone	Pirfenidone 267 mg/1	Tablet, Film coatedOral	Laurus Labs Limited	42385-924