What is NDC 50228-441?

50228-441 is the product NDC for Pirfenidone, Pirfenidone 267 mg/1 capsule, listed with the FDA by ScieGen Pharmaceuticals, Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.

ScieGen Pharmaceuticals, Inc., NDC labeler code 50228. 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 50228-441 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)50228-441Labeler and product segments. Claims need a package NDC.

Product NDC at billing width50228-0441Add 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
50228-441-05	5022804410550228044105	500 CAPSULE in 1 BOTTLE (50228-441-05)Marketed from Aug 1, 2022
50228-441-30	5022804413050228044130	30 CAPSULE in 1 BOTTLE (50228-441-30)Marketed from Aug 1, 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: ScieGen Pharmaceuticals, Inc.NDC labeler code 50228
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 212077
Marketing start: Aug 1, 2022
Listing expires: Dec 31, 2027
Other FDA classes: Pyridones (Chemical structure)
Identifiers: Product ID 50228-441_09c07f37-fe44-f211-e063-6394a90aae02SPL ID 09c07f37-fe44-f211-e063-6394a90aae02SPL set ID 1fbdb556-b164-4e0b-a95e-6004d50e3364RxCUI 1592279UNII 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

N450228044105 followed by a unit qualifier and the quantity

Package 50228-0441-05. 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 Nov 9, 2023.

Indications (excerpt from the label)

Pirfenidone is 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 50228-441

What is NDC 50228-441?: 50228-441 is the product NDC for Pirfenidone, Pirfenidone 267 mg/1 capsule, listed with the FDA by ScieGen Pharmaceuticals, Inc.. It has 2 package NDCs, 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?: ScieGen Pharmaceuticals, Inc., NDC labeler code 50228. 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 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	Cipla USA Inc.	69097-940
Pirfenidone	Pirfenidone 267 mg/1	CapsuleOral	EXELAN PHARMACEUTICALS INC.	76282-715