Risperidone NDC 13668-039

NDC codes

FDA NDC Directory

Product NDC (as listed)13668-039Labeler and product segments. Claims need a package NDC.

Product NDC at billing width13668-0039Add 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
13668-039-01	13668003901	100 TABLET in 1 BOTTLE (13668-039-01)Marketed from Jan 1, 2009
13668-039-05	13668003905	500 TABLET in 1 BOTTLE (13668-039-05)Marketed from Jan 1, 2009
13668-039-56	13668003956	2750 TABLET in 1 BOTTLE (13668-039-56)Marketed from Jan 1, 2009
13668-039-60	13668003960	60 TABLET in 1 BOTTLE (13668-039-60)Marketed from Jan 1, 2009

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 — 3 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Torrent Pharmaceuticals Limited
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 079088
Marketing start: Jan 1, 2009
Listing expires: Dec 31, 2027
Identifiers: Product ID 13668-039_cd8bfb14-7054-4c69-b27f-8a960b5ecb5fSPL ID cd8bfb14-7054-4c69-b27f-8a960b5ecb5fSPL set ID a6347895-5f16-43b4-92a0-b9904ac81937RxCUI 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

N413668003901 followed by a unit qualifier and the quantity

Package 13668-0039-01. 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 Mar 3, 2026. 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 tablets are 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 tablets are indicated for the treatment of acute manic o…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 079088

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

FDA NDC Directory listings under ANDA 079088
Product	Strength	Form · route	Labeler	Product NDC
Risperidone	Risperidone .5 mg/1	TabletOral	Torrent Pharmaceuticals Limited	13668-036
Risperidone	Risperidone .25 mg/1	TabletOral	Torrent Pharmaceuticals Limited	13668-035
Risperidone	Risperidone 4 mg/1	TabletOral	Torrent Pharmaceuticals Limited	13668-040
Risperidone	Risperidone 1 mg/1	TabletOral	Torrent Pharmaceuticals Limited	13668-037
Risperidone	Risperidone 2 mg/1	TabletOral	Torrent Pharmaceuticals Limited	13668-038
Risperidone	Risperidone 1 mg/1	TabletOral	PD-Rx Pharmaceuticals, Inc.	43063-254