Pirfenidone NDC 0781-8086

NDC codes

FDA NDC Directory

Product NDC (as listed)0781-8086Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00781-8086Add 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
0781-8086-92	00781808692	90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0781-8086-92)Marketed from May 2, 2022

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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 — 801 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: Sandoz Inc
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 212560
Marketing start: May 2, 2022
Listing expires: Dec 31, 2026
Other FDA classes: Pyridones (Chemical structure)
Identifiers: Product ID 0781-8086_b22f432a-14bf-44b2-bb86-63dc277ce7edSPL ID b22f432a-14bf-44b2-bb86-63dc277ce7edSPL set ID 7f5f7cc9-394e-4da0-87eb-84cfff9707a3RxCUI 1868014, 1868018UNII 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

N400781808692 followed by a unit qualifier and the quantity

Package 00781-8086-92. 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 Apr 30, 2023.

Indications (excerpt from the label)

Pirfenidone tablets are indicated for the treatment of idiopathic pulmonary fibrosis (IPF). Pirfenidone tablets are 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 212560

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

FDA NDC Directory listings under ANDA 212560
Product	Strength	Form · route	Labeler	Product NDC
Pirfenidone	Pirfenidone 267 mg/1	Tablet, Film coatedOral	Sandoz Inc	0781-8085