What is NDC 50228-478?

50228-478 is the product NDC for Aripiprazole, Aripiprazole 15 mg/1 tablet, 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 Aripiprazole?

251 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Aripiprazole NDC 50228-478 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)50228-478Labeler and product segments. Claims need a package NDC.

Product NDC at billing width50228-0478Add 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
50228-478-10	50228047810	1000 TABLET in 1 BOTTLE (50228-478-10)Marketed from Feb 25, 2020
50228-478-30	50228047830	30 TABLET in 1 BOTTLE (50228-478-30)Marketed from Feb 25, 2020

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): Aripiprazole
Generic name (nonproprietary): aripiprazole
Active ingredients: Aripiprazole — 15 mg/1
Dosage form: Tablet
Route: Oral
Labeler: ScieGen Pharmaceuticals IncNDC labeler code 50228
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 206383
Marketing start: Feb 24, 2020
Listing expires: Dec 31, 2026
Identifiers: Product ID 50228-478_f52587a6-f60d-515d-e053-2995a90aadb8SPL ID f52587a6-f60d-515d-e053-2995a90aadb8SPL set ID a7d9d5d1-25ba-4f4e-a990-398c0bf09c7eRxCUI 349490, 349545, 349547, 349553, 402131, 602964UNII 82VFR53I78UPC 0350228480307, 0350228475303, 0350228480109, 0350228479103, 0350228478106, 0350228477307, 0350228475105, 0350228476102, 0350228477109, 0350228479301, 0350228476300, 0350228478304
Pharmacologic class: Atypical Antipsychotic

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

N450228047810 followed by a unit qualifier and the quantity

Package 50228-0478-10. 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 Feb 20, 2023. This label includes a boxed warning.

Indications (excerpt from the label)

Aripiprazole tablets are indicated for the treatment of: Schizophrenia Irritability Associated with Autistic Disorder Treatment of Tourette’s Disorder Aripiprazole is an atypical antipsychotic. The oral formulation is indicated for: Schizophrenia ( 14.1 ) Irritability Associated with Autistic Disorder ( 14.4 ) Treatment of Tourette’s disorder ( 14.5 )

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 50228-478

What is NDC 50228-478?: 50228-478 is the product NDC for Aripiprazole, Aripiprazole 15 mg/1 tablet, 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?: Aripiprazole.
What is the active ingredient?: Aripiprazole.
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 Aripiprazole?: 251 other product NDCs are listed under this name. See all Aripiprazole 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 Aripiprazole NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Aripiprazole	Aripiprazole 15 mg/1	TabletOral	REMEDYREPACK INC.	70518-4745	70518-4745-00
Aripiprazole	Aripiprazole 10 mg/1	TabletOral	Coupler LLC	67046-0873	67046-0873-03
Aripiprazole	Aripiprazole 2 mg/1	TabletOral	Coupler LLC	67046-1052	67046-1052-03
Aripiprazole	Aripiprazole 15 mg/1	TabletOral	Coupler LLC	67046-2046	67046-2046-03
Aripiprazole	Aripiprazole 5 mg/1	TabletOral	Unit Dose Solutions, Inc.	87441-006	87441-0006-01
Aripiprazole	Aripiprazole 20 mg/1	TabletOral	Coupler LLC	67046-1085	67046-1085-03
Aripiprazole	Aripiprazole 5 mg/1	TabletOral	Coupler LLC	67046-0885	67046-0885-03
Aripiprazole	Aripiprazole 15 mg/1	TabletOral	Coupler LLC	67046-1017	67046-1017-03
Aripiprazole	Aripiprazole 10 mg/1	TabletOral	Coupler LLC	67046-0492	67046-0492-03
Aripiprazole	Aripiprazole 10 mg/1	Tablet, Orally disintegratingOral	Aurobindo Pharma Limited	59651-514	59651-0514-0359651-0514-30

All 252 Aripiprazole NDCs

Other NDCs under ANDA 206383

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

FDA NDC Directory listings under ANDA 206383
Product	Strength	Form · route	Labeler	Product NDC
Aripiprazole	Aripiprazole 2 mg/1	TabletOral	ScieGen Pharmaceuticals Inc	50228-324
Aripiprazole	Aripiprazole 2 mg/1	TabletOral	NCS HealthCare of KY, LLC dba Vangard Labs	0615-8524
Aripiprazole	Aripiprazole 20 mg/1	TabletOral	ScieGen Pharmaceuticals Inc	50228-328
Aripiprazole	Aripiprazole 30 mg/1	TabletOral	ScieGen Pharmaceuticals Inc	50228-329
Aripiprazole	Aripiprazole 5 mg/1	TabletOral	Dr.Reddys Laboratories Inc	43598-555
Aripiprazole	Aripiprazole 2 mg/1	TabletOral	Dr.Reddys Laboratories Inc	43598-554
Aripiprazole	Aripiprazole 30 mg/1	TabletOral	Dr.Reddys Laboratories Inc	43598-559
Aripiprazole	Aripiprazole 10 mg/1	TabletOral	Dr.Reddys Laboratories Inc	43598-556
Aripiprazole	Aripiprazole 15 mg/1	TabletOral	Dr.Reddys Laboratories Inc	43598-557
Aripiprazole	Aripiprazole 20 mg/1	TabletOral	Dr.Reddys Laboratories Inc	43598-558
Aripiprazole	Aripiprazole 5 mg/1	TabletOral	ScieGen Pharmaceuticals Inc	50228-476
Aripiprazole	Aripiprazole 2 mg/1	TabletOral	ScieGen Pharmaceuticals Inc	50228-475
Aripiprazole	Aripiprazole 30 mg/1	TabletOral	ScieGen Pharmaceuticals Inc	50228-480
Aripiprazole	Aripiprazole 10 mg/1	TabletOral	ScieGen Pharmaceuticals Inc	50228-477
Aripiprazole	Aripiprazole 20 mg/1	TabletOral	ScieGen Pharmaceuticals Inc	50228-479
Aripiprazole	Aripiprazole 15 mg/1	TabletOral	ScieGen Pharmaceuticals Inc	50228-327
Aripiprazole	Aripiprazole 5 mg/1	TabletOral	ScieGen Pharmaceuticals Inc	50228-325
Aripiprazole	Aripiprazole 10 mg/1	TabletOral	NCS HealthCare of KY, LLC dba Vangard Labs	0615-8525
Aripiprazole	Aripiprazole 10 mg/1	TabletOral	ScieGen Pharmaceuticals Inc	50228-326
Aripiprazole	Aripiprazole 5 mg/1	TabletOral	NCS HealthCare of KY, LLC dba Vangard Labs	0615-8375

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