Pirfenidone NDC 60219-1642

NDC codes

FDA NDC Directory

Product NDC (as listed)60219-1642Labeler and product segments. Claims need a package NDC.

Product NDC at billing width60219-1642Add 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
60219-1642-7	60219164207	1 BOTTLE in 1 CARTON (60219-1642-7) / 270 CAPSULE in 1 BOTTLEMarketed from Jan 7, 2022

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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: Amneal Pharmaceuticals NY LLC
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 212569
Marketing start: Jan 7, 2022
Listing expires: Dec 31, 2026
Other FDA classes: Pyridones (Chemical structure)
Identifiers: Product ID 60219-1642_7e3cb259-54a9-45b5-b2c4-3edc4a515d54SPL ID 7e3cb259-54a9-45b5-b2c4-3edc4a515d54SPL set ID 1d4d7aa2-1248-4639-baf5-5e2ae72cbcd8RxCUI 1592279UNII D7NLD2JX7UUPC 0360219164277
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

N460219164207 followed by a unit qualifier and the quantity

Package 60219-1642-07. 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 Feb 28, 2025.

Indications (excerpt from the label)

Pirfenidone capsules 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 212569

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

FDA NDC Directory listings under ANDA 212569
Product	Strength	Form · route	Labeler	Product NDC
Pirfenidone	Pirfenidone 267 mg/1	CapsuleOral	AvKARE	42291-490
Pirfenidone	Pirfenidone 267 mg/1	CapsuleOral	Amneal Pharmaceuticals NY LLC	69238-1642