What is NDC 63304-951?

63304-951 is the product NDC for Risperidone, Risperidone 2 mg/1 tablet, orally disintegrating, listed with the FDA by Sun Pharmaceutical Industries, Inc.. It has 3 package NDCs, shown above in 10- and 11-digit form.

Sun Pharmaceutical Industries, Inc., NDC labeler code 63304. 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 63304-951 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)63304-951Labeler and product segments. Claims need a package NDC.

Product NDC at billing width63304-0951Add 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
63304-951-05	63304095105	500 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (63304-951-05)Marketed from Aug 6, 2010
63304-951-17	63304095117	10 POUCH in 1 BOX, UNIT-DOSE (63304-951-17) / 1 TABLET, ORALLY DISINTEGRATING in 1 POUCH (63304-951-11)Marketed from Aug 6, 2010
63304-951-30	63304095130	30 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (63304-951-30)Marketed from Aug 6, 2010

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 — 2 mg/1
Dosage form: Tablet, Orally disintegrating
Route: Oral
Labeler: Sun Pharmaceutical Industries, Inc.NDC labeler code 63304
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 077542
Marketing start: Aug 6, 2010
Listing expires: Dec 31, 2026
Identifiers: Product ID 63304-951_8c155c45-e5c8-4358-90da-8f6d193ad88bSPL ID 8c155c45-e5c8-4358-90da-8f6d193ad88bSPL set ID f91f551e-926f-440d-83d2-357e9d7484feRxCUI 401953, 401954, 403825, 616698, 616705UNII L6UH7ZF8HCUPC 0363304949308
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

N463304095105 followed by a unit qualifier and the quantity

Package 63304-0951-05. 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 Jul 13, 2022. This label includes a boxed warning.

Indications (excerpt from the label)

Risperidone orally disintegrating tablet 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 orally disintegrating 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 orally d…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 63304-951

What is NDC 63304-951?: 63304-951 is the product NDC for Risperidone, Risperidone 2 mg/1 tablet, orally disintegrating, listed with the FDA by Sun Pharmaceutical Industries, Inc.. It has 3 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?: Sun Pharmaceutical Industries, Inc., NDC labeler code 63304. 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 077542

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

FDA NDC Directory listings under ANDA 077542
Product	Strength	Form · route	Labeler	Product NDC
Risperidone	Risperidone .5 mg/1	Tablet, Orally disintegratingOral	Sun Pharmaceutical Industries, Inc.	63304-949
Risperidone	Risperidone 1 mg/1	Tablet, Orally disintegratingOral	Sun Pharmaceutical Industries, Inc.	63304-950