Pirfenidone NDC 60505-4681

NDC codes

FDA NDC Directory

Product NDC (as listed)60505-4681Labeler and product segments. Claims need a package NDC.

Product NDC at billing width60505-4681Add 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
60505-4681-7	60505468107	270 TABLET in 1 BOTTLE (60505-4681-7)Marketed from Apr 9, 2024
60505-4681-9	60505468109	90 TABLET in 1 BOTTLE (60505-4681-9)Marketed from Apr 9, 2024

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: Tablet
Route: Oral
Labeler: Apotex Corp.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 212709
Marketing start: Apr 9, 2024
Listing expires: Dec 31, 2027
Other FDA classes: Pyridones (Chemical structure)
Identifiers: Product ID 60505-4681_9fc7c490-3a02-c87d-8ecf-a7ad374237bfSPL ID 9fc7c490-3a02-c87d-8ecf-a7ad374237bf
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

N460505468107 followed by a unit qualifier and the quantity

Package 60505-4681-07. 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

The FDA listing for this product does not reference a label (SPL) set.

Other NDCs under ANDA 212709

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

FDA NDC Directory listings under ANDA 212709
Product	Strength	Form · route	Labeler	Product NDC
Pirfenidone	Pirfenidone 267 mg/1	TabletOral	Golden State Medical Supply, Inc.	51407-913
Pirfenidone	Pirfenidone 801 mg/1	TabletOral	Golden State Medical Supply, Inc.	51407-914
Pirfenidone	Pirfenidone 801 mg/1	TabletOral	Apotex Corp.	60505-4682