What is NDC 69238-1641?

69238-1641 is the product NDC for Pirfenidone, Pirfenidone 801 mg/1 tablet, film coated, listed with the FDA by Amneal Pharmaceuticals NY LLC. It has 1 package NDC, shown above in 10- and 11-digit form.

Amneal Pharmaceuticals NY LLC, NDC labeler code 69238. 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 69238-1641 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)69238-1641Labeler and product segments. Claims need a package NDC.

Product NDC at billing width69238-1641Add 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
69238-1641-9	6923816410969238164109	1 BOTTLE, PLASTIC in 1 CARTON (69238-1641-9) / 90 TABLET, FILM COATED in 1 BOTTLE, PLASTICMarketed from Feb 28, 2023

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 — 801 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: Amneal Pharmaceuticals NY LLCNDC labeler code 69238
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 212570
Marketing start: Feb 28, 2023
Listing expires: Dec 31, 2027
Other FDA classes: Pyridones (Chemical structure)
Identifiers: Product ID 69238-1641_08b2264e-d081-4558-9893-0a11d25e7a39SPL ID 08b2264e-d081-4558-9893-0a11d25e7a39SPL set ID a235768d-d26d-4ded-ae75-53e93310ff6aRxCUI 1868014, 1868018UNII D7NLD2JX7U
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

N469238164109 followed by a unit qualifier and the quantity

Package 69238-1641-09. 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 Apr 10, 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)

About NDC 69238-1641

What is NDC 69238-1641?: 69238-1641 is the product NDC for Pirfenidone, Pirfenidone 801 mg/1 tablet, film coated, listed with the FDA by Amneal Pharmaceuticals NY LLC. 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?: Amneal Pharmaceuticals NY LLC, NDC labeler code 69238. 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 212570

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

FDA NDC Directory listings under ANDA 212570
Product	Strength	Form · route	Labeler	Product NDC
Pirfenidone	Pirfenidone 267 mg/1	Tablet, Film coatedOral	AvKARE	42291-491
Pirfenidone	Pirfenidone 801 mg/1	Tablet, Film coatedOral	AvKARE	42291-492
Pirfenidone	Pirfenidone 267 mg/1	Tablet, Film coatedOral	Amneal Pharmaceuticals NY LLC	60219-1640
Pirfenidone	Pirfenidone 801 mg/1	Tablet, Film coatedOral	Amneal Pharmaceuticals NY LLC	60219-1641
Pirfenidone	Pirfenidone 267 mg/1	Tablet, Film coatedOral	Amneal Pharmaceuticals NY LLC	69238-1640