What is NDC 0615-8375?

0615-8375 is the product NDC for Aripiprazole, Aripiprazole 5 mg/1 tablet, listed with the FDA by NCS HealthCare of KY, LLC dba Vangard Labs. It has 1 package NDC, shown above in 10- and 11-digit form.

NCS HealthCare of KY, LLC dba Vangard Labs, NDC labeler code 0615. 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?

254 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 0615-8375 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)0615-8375Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00615-8375Add 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
0615-8375-39	0061583753900615837539	30 TABLET in 1 BLISTER PACK (0615-8375-39)Marketed from Feb 3, 2021

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): Aripiprazole
Generic name (nonproprietary): aripiprazole
Active ingredients: Aripiprazole — 5 mg/1
Dosage form: Tablet
Route: Oral
Labeler: NCS HealthCare of KY, LLC dba Vangard LabsNDC labeler code 0615
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 206383
Marketing start: Mar 16, 2020
Listing expires: Dec 31, 2027
Identifiers: Product ID 0615-8375_e8de660c-3ea9-489c-aca4-8b7c6e3f428fSPL ID e8de660c-3ea9-489c-aca4-8b7c6e3f428fSPL set ID 8da99c93-613e-4b78-9f91-3efc2dea194dRxCUI 402131UNII 82VFR53I78
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

N400615837539 followed by a unit qualifier and the quantity

Package 00615-8375-39. 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 Aug 2, 2022. This label includes a boxed warning.

Indications (excerpt from the label)

Aripiprazole tablets are indicated for the treatment of: Schizophrenia [ see CLINICAL STUDIES ( 14.1 ) ] Additional pediatric use information is approved for Otsuka America Pharmaceutical, Inc.’s ABILIFY ® (aripiprazole) product. However, due to Otsuka America Pharmaceutical, Inc.’s marketing exclusivity rights, this drug product is not labeled with that information. Aripiprazole is an atypical antipsychotic. The oral formulation is indicated for: Schizophrenia ( 14.1 )

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0615-8375

What is NDC 0615-8375?: 0615-8375 is the product NDC for Aripiprazole, Aripiprazole 5 mg/1 tablet, listed with the FDA by NCS HealthCare of KY, LLC dba Vangard Labs. It has 1 package NDC, 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?: NCS HealthCare of KY, LLC dba Vangard Labs, NDC labeler code 0615. 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?: 254 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 255 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	50228-475
Aripiprazole	Aripiprazole 5 mg/1	TabletOral	ScieGen Pharmaceuticals Inc	50228-476
Aripiprazole	Aripiprazole 10 mg/1	TabletOral	ScieGen Pharmaceuticals Inc	50228-477
Aripiprazole	Aripiprazole 15 mg/1	TabletOral	ScieGen Pharmaceuticals Inc	50228-478
Aripiprazole	Aripiprazole 20 mg/1	TabletOral	ScieGen Pharmaceuticals Inc	50228-479
Aripiprazole	Aripiprazole 30 mg/1	TabletOral	ScieGen Pharmaceuticals Inc	50228-480
Aripiprazole	Aripiprazole 2 mg/1	TabletOral	Dr.Reddys Laboratories Inc	43598-965
Aripiprazole	Aripiprazole 15 mg/1	TabletOral	Dr.Reddys Laboratories Inc	43598-968
Aripiprazole	Aripiprazole 5 mg/1	TabletOral	Dr.Reddys Laboratories Inc	43598-966
Aripiprazole	Aripiprazole 10 mg/1	TabletOral	Dr.Reddys Laboratories Inc	43598-967
Aripiprazole	Aripiprazole 20 mg/1	TabletOral	Dr.Reddys Laboratories Inc	43598-969
Aripiprazole	Aripiprazole 30 mg/1	TabletOral	Dr.Reddys Laboratories Inc	43598-970
Aripiprazole	Aripiprazole 2 mg/1	TabletOral	NCS HealthCare of KY, LLC dba Vangard Labs	0615-8524
Aripiprazole	Aripiprazole 10 mg/1	TabletOral	NCS HealthCare of KY, LLC dba Vangard Labs	0615-8525
Aripiprazole	Aripiprazole 15 mg/1	TabletOral	Dr.Reddys Laboratories Inc	43598-557
Aripiprazole	Aripiprazole 2 mg/1	TabletOral	Dr.Reddys Laboratories Inc	43598-554
Aripiprazole	Aripiprazole 5 mg/1	TabletOral	Dr.Reddys Laboratories Inc	43598-555
Aripiprazole	Aripiprazole 10 mg/1	TabletOral	Dr.Reddys Laboratories Inc	43598-556
Aripiprazole	Aripiprazole 20 mg/1	TabletOral	Dr.Reddys Laboratories Inc	43598-558
Aripiprazole	Aripiprazole 30 mg/1	TabletOral	Dr.Reddys Laboratories Inc	43598-559

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