What is NDC 68382-117?

68382-117 is the product NDC for risperidone, Risperidone 4 mg/1 tablet, film coated, listed with the FDA by Zydus Pharmaceuticals USA Inc.. It has 6 package NDCs, shown above in 10- and 11-digit form.

Zydus Pharmaceuticals USA Inc., NDC labeler code 68382. 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 68382-117 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)68382-117Labeler and product segments. Claims need a package NDC.

Product NDC at billing width68382-0117Add 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
68382-117-01	68382011701	100 TABLET, FILM COATED in 1 BOTTLE (68382-117-01)Marketed from Nov 13, 2008
68382-117-05	68382011705	500 TABLET, FILM COATED in 1 BOTTLE (68382-117-05)Marketed from Nov 13, 2008
68382-117-06	68382011706	30 TABLET, FILM COATED in 1 BOTTLE (68382-117-06)Marketed from Nov 13, 2008
68382-117-10	68382011710	1000 TABLET, FILM COATED in 1 BOTTLE (68382-117-10)Marketed from Nov 13, 2008
68382-117-14	68382011714	60 TABLET, FILM COATED in 1 BOTTLE (68382-117-14)Marketed from Nov 13, 2008
68382-117-16	68382011716	90 TABLET, FILM COATED in 1 BOTTLE (68382-117-16)Marketed from Nov 13, 2008

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): risperidone
Generic name (nonproprietary): risperidone
Active ingredients: Risperidone — 4 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: Zydus Pharmaceuticals USA Inc.NDC labeler code 68382
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 078040
Marketing start: Nov 13, 2008
Listing expires: Dec 31, 2026
Identifiers: Product ID 68382-117_2af53e64-46a6-4b12-9ac8-8f8031a8bd97SPL ID 2af53e64-46a6-4b12-9ac8-8f8031a8bd97SPL set ID 713b5ac7-53d6-4139-8599-3028f789de4bRxCUI 312828, 312829, 312830, 312831, 312832, 314211UNII 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

N468382011701 followed by a unit qualifier and the quantity

Package 68382-0117-01. 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 Jun 14, 2025. 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 a…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 68382-117

What is NDC 68382-117?: 68382-117 is the product NDC for risperidone, Risperidone 4 mg/1 tablet, film coated, listed with the FDA by Zydus Pharmaceuticals USA Inc.. It has 6 package NDCs, 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?: Zydus Pharmaceuticals USA Inc., NDC labeler code 68382. 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 078040

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

FDA NDC Directory listings under ANDA 078040
Product	Strength	Form · route	Labeler	Product NDC
risperidone	Risperidone .25 mg/1	Tablet, Film coatedOral	Major Pharmaceuticals	0904-7360
risperidone	Risperidone .5 mg/1	Tablet, Film coatedOral	Major Pharmaceuticals	0904-7361
risperidone	Risperidone 1 mg/1	Tablet, Film coatedOral	Major Pharmaceuticals	0904-7362
risperidone	Risperidone 2 mg/1	Tablet, Film coatedOral	Major Pharmaceuticals	0904-7363
risperidone	Risperidone 3 mg/1	Tablet, Film coatedOral	Major Pharmaceuticals	0904-7364
risperidone	Risperidone 4 mg/1	Tablet, Film coatedOral	Major Pharmaceuticals	0904-7365
risperidone	Risperidone .5 mg/1	Tablet, Film coatedOral	Cardinal Health 107, LLC	55154-0180
risperidone	Risperidone 1 mg/1	Tablet, Film coatedOral	Cardinal Health 107, LLC	55154-2634
risperidone	Risperidone .25 mg/1	Tablet, Film coatedOral	Proficient Rx LP	63187-418
risperidone	Risperidone .25 mg/1	Tablet, Film coatedOral	Zydus Lifesciences Limited	65841-665
risperidone	Risperidone .5 mg/1	Tablet, Film coatedOral	Zydus Lifesciences Limited	65841-666
risperidone	Risperidone 1 mg/1	Tablet, Film coatedOral	Zydus Lifesciences Limited	65841-667
risperidone	Risperidone 2 mg/1	Tablet, Film coatedOral	Zydus Lifesciences Limited	65841-668
risperidone	Risperidone 3 mg/1	Tablet, Film coatedOral	Zydus Lifesciences Limited	65841-669
risperidone	Risperidone 4 mg/1	Tablet, Film coatedOral	Zydus Lifesciences Limited	65841-670
Risperidone	Risperidone .25 mg/1	Tablet, Film coatedOral	American Health Packaging	68084-270
Risperidone	Risperidone .5 mg/1	Tablet, Film coatedOral	American Health Packaging	68084-271
Risperidone	Risperidone 1 mg/1	Tablet, Film coatedOral	American Health Packaging	68084-272
Risperidone	Risperidone 2 mg/1	Tablet, Film coatedOral	American Health Packaging	68084-273
Risperidone	Risperidone 3 mg/1	Tablet, Film coatedOral	American Health Packaging	68084-274

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