Pirfenidone NDC 46708-480

NDC codes

FDA NDC Directory

Product NDC (as listed)46708-480Labeler and product segments. Claims need a package NDC.

Product NDC at billing width46708-0480Add 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
46708-480-71	46708048071	500 TABLET, COATED in 1 BOTTLE (46708-480-71)Marketed from Jun 10, 2022
46708-480-90	46708048090	90 TABLET, COATED in 1 BOTTLE (46708-480-90)Marketed from Jun 10, 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 — 801 mg/1
Dosage form: Tablet, Coated
Route: Oral
Labeler: Alembic Pharmaceuticals Limited
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 212708
Marketing start: Jun 10, 2022
Listing expires: Dec 31, 2026
Other FDA classes: Pyridones (Chemical structure)
Identifiers: Product ID 46708-480_5dd2966d-35b0-4a80-a677-bca6f4c69311SPL ID 5dd2966d-35b0-4a80-a677-bca6f4c69311SPL set ID 6e4f991a-c9e3-4121-97d0-d07954f17336RxCUI 1868014, 1868018UNII D7NLD2JX7UUPC 0346708479718
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

N446708048071 followed by a unit qualifier and the quantity

Package 46708-0480-71. 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 Mar 30, 2023.

Indications (excerpt from the label)

Pirfenidone tablets are 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 212708

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

FDA NDC Directory listings under ANDA 212708
Product	Strength	Form · route	Labeler	Product NDC
Pirfenidone	Pirfenidone 267 mg/1	Tablet, CoatedOral	Alembic Pharmaceuticals Inc.	62332-479
Pirfenidone	Pirfenidone 801 mg/1	Tablet, CoatedOral	Alembic Pharmaceuticals Inc.	62332-480
Pirfenidone	Pirfenidone 267 mg/1	Tablet, CoatedOral	Alembic Pharmaceuticals Limited	46708-479
Pirfenidone	Pirfenidone 267 mg/1	Tablet, CoatedOral	Bryant Ranch Prepack	72162-2465
Pirfenidone	Pirfenidone 801 mg/1	Tablet, CoatedOral	Bryant Ranch Prepack	72162-2466
Pirfenidone	Pirfenidone 267 mg/1	Tablet, CoatedOral	Bryant Ranch Prepack	71335-2944
Pirfenidone	Pirfenidone 801 mg/1	Tablet, CoatedOral	Bryant Ranch Prepack	71335-2984