What is NDC 0904-7397?

0904-7397 is the product NDC for Pirfenidone, Pirfenidone 267 mg/1 tablet, film coated, listed with the FDA by MAJOR PHARMACEUTICALS. It has 1 package NDC, shown above in 10- and 11-digit form.

MAJOR PHARMACEUTICALS, NDC labeler code 0904. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Pirfenidone?

54 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Pirfenidone NDC 0904-7397 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)0904-7397Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00904-7397Add 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
0904-7397-53	0090473975300904739753	3 BOTTLE in 1 CARTON (0904-7397-53) / 90 TABLET, FILM COATED in 1 BOTTLE (0904-7397-89)Marketed from Mar 2, 2024

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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: Tablet, Film coated
Route: Oral
Labeler: MAJOR PHARMACEUTICALSNDC labeler code 0904
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 212772
Marketing start: May 24, 2022
Listing expires: Dec 31, 2027
Other FDA classes: Pyridones (Chemical structure)
Identifiers: Product ID 0904-7397_24b60d05-c1f7-4fba-ba4f-009eceb0c409SPL ID 24b60d05-c1f7-4fba-ba4f-009eceb0c409
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

N400904739753 followed by a unit qualifier and the quantity

Package 00904-7397-53. 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.

About NDC 0904-7397

What is NDC 0904-7397?: 0904-7397 is the product NDC for Pirfenidone, Pirfenidone 267 mg/1 tablet, film coated, listed with the FDA by MAJOR PHARMACEUTICALS. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Pirfenidone.
What is the active ingredient?: Pirfenidone.
Who is the labeler?: MAJOR PHARMACEUTICALS, NDC labeler code 0904. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Pirfenidone?: 54 other product NDCs are listed under this name. See all Pirfenidone NDCs.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Pirfenidone NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Pirfenidone	Pirfenidone 267 mg/1	CapsuleOral	Aurobindo Pharma Limited	59651-244	59651-0244-2759651-0244-2859651-0244-42
Pirfenidone	Pirfenidone 267 mg/1	TabletOral	Aurobindo Pharma Limited	59651-238	59651-0238-27
Pirfenidone	Pirfenidone 801 mg/1	TabletOral	Aurobindo Pharma Limited	59651-239	59651-0239-90
Pirfenidone	Pirfenidone 267 mg/1	TabletOral	Apotex Corp.	60505-4681	60505-4681-0760505-4681-09
Pirfenidone	Pirfenidone 801 mg/1	TabletOral	Apotex Corp.	60505-4682	60505-4682-09
Pirfenidone	Pirfenidone 267 mg/1	CapsuleOral	AvKARE	42291-490	42291-0490-27
Pirfenidone	Pirfenidone 267 mg/1	Tablet, Film coatedOral	AvKARE	42291-491	42291-0491-27
Pirfenidone	Pirfenidone 801 mg/1	Tablet, Film coatedOral	AvKARE	42291-492	42291-0492-09
Pirfenidone	Pirfenidone 267 mg/1	TabletOral	Golden State Medical Supply, Inc.	51407-913	51407-0913-27
Pirfenidone	Pirfenidone 801 mg/1	TabletOral	Golden State Medical Supply, Inc.	51407-914	51407-0914-90

All 55 Pirfenidone NDCs

Other NDCs under ANDA 212772

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

FDA NDC Directory listings under ANDA 212772
Product	Strength	Form · route	Labeler	Product NDC
Pirfenidone	Pirfenidone 801 mg/1	Tablet, Film coatedOral	MAJOR PHARMACEUTICALS	0904-7398
Pirfenidone	Pirfenidone 267 mg/1	Tablet, Film coatedOral	Novadoz Pharmaceuticals LLC	72205-181
Pirfenidone	Pirfenidone 801 mg/1	Tablet, Film coatedOral	Novadoz Pharmaceuticals LLC	72205-182
Pirfenidone	Pirfenidone 267 mg/1	Tablet, Film coatedOral	Northstar Rx LLC	72603-258
Pirfenidone	Pirfenidone 801 mg/1	Tablet, Film coatedOral	Northstar Rx LLC	72603-259