Pirfenidone NDC 70954-869

NDC codes

FDA NDC Directory

Product NDC (as listed)70954-869Labeler and product segments. Claims need a package NDC.

Product NDC at billing width70954-0869Add 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
70954-869-10	70954086910	3 BOTTLE in 1 CARTON (70954-869-10) / 90 TABLET, FILM COATED in 1 BOTTLEMarketed from Jul 19, 2022
70954-869-30	70954086930	270 TABLET, FILM COATED in 1 BOTTLE (70954-869-30)Marketed from Feb 28, 2024

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: ANI Pharmaceuticals, Inc.
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 70954-869_fd354df5-de31-47d3-a67b-a45ad121153eSPL ID fd354df5-de31-47d3-a67b-a45ad121153eSPL set ID 976620bb-c10e-4b13-8a97-7025fda6b7d5RxCUI 1868014, 1868018UNII D7NLD2JX7UUPC 0370954870104, 0370954869306
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

N470954086910 followed by a unit qualifier and the quantity

Package 70954-0869-10. 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 Sep 17, 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 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
Pirfenidone	Pirfenidone 534 mg/1	Tablet, Film coatedOral	Laurus Labs Limited	42385-925