Pirfenidone NDC 0781-2158

NDC codes

FDA NDC Directory

Product NDC (as listed)0781-2158Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00781-2158Add 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
0781-2158-32	00781215832	270 CAPSULE in 1 BOTTLE, PLASTIC (0781-2158-32)Marketed from Jan 9, 2023

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 — 267 mg/1
Dosage form: Capsule
Route: Oral
Labeler: Sandoz Inc
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 212600
Marketing start: Jan 9, 2023
Listing expires: Dec 31, 2026
Other FDA classes: Pyridones (Chemical structure)
Identifiers: Product ID 0781-2158_dec54143-b962-4f6c-a59c-578d93ca1142SPL ID dec54143-b962-4f6c-a59c-578d93ca1142SPL set ID 945d4337-7d18-4d84-807b-8ae13750c76dRxCUI 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

N400781215832 followed by a unit qualifier and the quantity

Package 00781-2158-32. 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 Oct 30, 2024.

Indications (excerpt from the label)

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