What is NDC 0615-8288?

0615-8288 is the product NDC for Risperidone, Risperidone 2 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 Risperidone?

168 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Risperidone NDC 0615-8288 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)0615-8288Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00615-8288Add 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
0615-8288-39	0061582883900615828839	30 TABLET in 1 BLISTER PACK (0615-8288-39)Marketed from Jun 5, 2019

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): Risperidone
Generic name (nonproprietary): risperidone
Active ingredients: Risperidone — 2 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 077493
Marketing start: Jun 1, 2015
Listing expires: Dec 31, 2027
Identifiers: Product ID 0615-8288_102140c8-c00e-4498-8e1a-322d5de68198SPL ID 102140c8-c00e-4498-8e1a-322d5de68198SPL set ID 7bbc37f1-6d6a-4021-8976-1f103ce1cfbdRxCUI 312828, 312829, 312830, 312831, 312832UNII L6UH7ZF8HC
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

N400615828839 followed by a unit qualifier and the quantity

Package 00615-8288-39. 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 Feb 27, 2023. This label includes a boxed warning.

Indications (excerpt from the label)

Risperidone is an atypical antipsychotic indicated for: Treatment of schizophrenia ( 1.1 ) As monotherapy or adjunctive therapy with lithium or valproate, for the treatment of acute manic or mixed episodes associated with Bipolar I Disorder ( 1.2 ) Treatment of irritability associated with autistic disorder ( 1.3 ) 1.1 Schizophrenia Risperidone is indicated for the treatment of schizophrenia. Efficacy was established in 4 short-term trials in adults, 2 short-term trials in adolescents (ages 13 to 17 years), and one long-term maintenance trial in adults [see Clinical Studies ( 14.1 )]. 1.2 Bipolar Mania Monotherapy Risperidone is indicated for the treatment of acute manic or mixed episodes as…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0615-8288

What is NDC 0615-8288?: 0615-8288 is the product NDC for Risperidone, Risperidone 2 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?: Risperidone.
What is the active ingredient?: Risperidone.
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 Risperidone?: 168 other product NDCs are listed under this name. See all Risperidone 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 Risperidone NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Risperidone	Risperidone .5 mg/1	Tablet, Orally disintegratingOral	Amerisyn LLC	87564-013	87564-0013-28
Risperidone	Risperidone 1 mg/1	Tablet, Orally disintegratingOral	Amerisyn LLC	87564-014	87564-0014-28
Risperidone	Risperidone 2 mg/1	Tablet, Orally disintegratingOral	Amerisyn LLC	87564-015	87564-0015-28
Risperidone	Risperidone 3 mg/1	Tablet, Orally disintegratingOral	Amerisyn LLC	87564-016	87564-0016-28
Risperidone	Risperidone 4 mg/1	Tablet, Orally disintegratingOral	Amerisyn LLC	87564-017	87564-0017-28
Risperidone	Risperidone .5 mg/1	TabletOral	Coupler LLC	67046-0644	67046-0644-03
Risperidone	Risperidone .25 mg/1	TabletOral	Coupler LLC	67046-2064	67046-2064-03
Risperidone	Risperidone 1 mg/1	TabletOral	Coupler LLC	67046-0635	67046-0635-03
Risperidone	Risperidone 2 mg/1	TabletOral	Coupler LLC	67046-0630	67046-0630-03
Risperidone	Risperidone .5 mg/1	Tablet, Orally disintegratingOral	Amici Pharma, Inc.	69292-571	69292-0571-30

All 169 Risperidone NDCs

Other NDCs under ANDA 077493

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

FDA NDC Directory listings under ANDA 077493
Product	Strength	Form · route	Labeler	Product NDC
Risperidone	Risperidone .25 mg/1	TabletOral	NCS HealthCare of KY, LLC dba Vangard Labs	0615-8196
Risperidone	Risperidone .5 mg/1	TabletOral	NCS HealthCare of KY, LLC dba Vangard Labs	0615-8197
Risperidone	Risperidone 1 mg/1	TabletOral	NCS HealthCare of KY, LLC dba Vangard Labs	0615-8198
Risperidone	Risperidone 3 mg/1	TabletOral	NCS HealthCare of KY, LLC dba Vangard Labs	0615-8265
Risperidone	Risperidone .25 mg/1	TabletOral	Solco Healthcare US, LLC	43547-339
Risperidone	Risperidone .5 mg/1	TabletOral	Solco Healthcare US, LLC	43547-340
Risperidone	Risperidone 1 mg/1	TabletOral	Solco Healthcare US, LLC	43547-341
Risperidone	Risperidone 2 mg/1	TabletOral	Solco Healthcare US, LLC	43547-342
Risperidone	Risperidone 3 mg/1	TabletOral	Solco Healthcare US, LLC	43547-343
Risperidone	Risperidone 4 mg/1	TabletOral	Solco Healthcare US, LLC	43547-344
Risperidone	Risperidone .25 mg/1	TabletOral	Coupler LLC	67046-2064
Risperidone	Risperidone 1 mg/1	TabletOral	NuCare Pharmaceuticals, Inc.	68071-3873
Risperidone	Risperidone 1 mg/1	TabletOral	REMEDYREPACK INC.	70518-3883
Risperidone	Risperidone 3 mg/1	TabletOral	REMEDYREPACK INC.	70518-4426
Risperidone	Risperidone 2 mg/1	TabletOral	REMEDYREPACK INC.	70518-4431
Risperidone	Risperidone 2 mg/1	TabletOral	Bryant Ranch Prepack	71335-2645
Risperidone	Risperidone 2 mg/1	TabletOral	Aphena Pharma Solutions - Tennessee, LLC	71610-259