Pirfenidone NDC 69097-940

NDC codes

FDA NDC Directory

Product NDC (as listed)69097-940Labeler and product segments. Claims need a package NDC.

Product NDC at billing width69097-0940Add 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
69097-940-04	69097094004	90 CAPSULE in 1 BOTTLE (69097-940-04)Marketed from Aug 2, 2022
69097-940-93	69097094093	270 CAPSULE in 1 BOTTLE (69097-940-93)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: Cipla USA 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 69097-940_160109da-da53-45a8-840a-e41384710033SPL ID 160109da-da53-45a8-840a-e41384710033SPL set ID 16fca4fc-b641-4ee8-a2ee-a35189ce1f3bRxCUI 1592279UNII D7NLD2JX7UUPC 0369097940935, 0369097940041
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

N469097094004 followed by a unit qualifier and the quantity

Package 69097-0940-04. 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

Label details couldn’t be retrieved right now. Open the label on DailyMed.

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	EXELAN PHARMACEUTICALS INC.	76282-715
Pirfenidone	Pirfenidone 267 mg/1	CapsuleOral	ScieGen Pharmaceuticals, Inc.	50228-441