Pirfenidone NDC 76282-715

NDC codes

FDA NDC Directory

Product NDC (as listed)76282-715Labeler and product segments. Claims need a package NDC.

Product NDC at billing width76282-0715Add 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
76282-715-27	76282071527	270 CAPSULE in 1 BOTTLE (76282-715-27)Marketed from Aug 2, 2022
76282-715-90	76282071590	90 CAPSULE in 1 BOTTLE (76282-715-90)Marketed from Aug 2, 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: Capsule
Route: Oral
Labeler: EXELAN PHARMACEUTICALS INC.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 212077
Marketing start: Aug 2, 2022
Listing expires: Dec 31, 2026
Other FDA classes: Pyridones (Chemical structure)
Identifiers: Product ID 76282-715_2696c9c1-fdbb-4135-862e-ab4cd18ad2aaSPL ID 2696c9c1-fdbb-4135-862e-ab4cd18ad2aaSPL set ID 1709582c-9975-4dc1-8181-2501ee670eefRxCUI 1592279UNII D7NLD2JX7UUPC 0376282715902, 0376282715278
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

N476282071527 followed by a unit qualifier and the quantity

Package 76282-0715-27. 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 Jan 20, 2023.

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 212077

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

FDA NDC Directory listings under ANDA 212077
Product	Strength	Form · route	Labeler	Product NDC
Pirfenidone	Pirfenidone 267 mg/1	CapsuleOral	ScieGen Pharmaceuticals, Inc.	50228-441
Pirfenidone	Pirfenidone 267 mg/1	CapsuleOral	Cipla USA Inc.	69097-940