Risperidone NDC 59746-050

NDC codes

FDA NDC Directory

Product NDC (as listed)59746-050Labeler and product segments. Claims need a package NDC.

Product NDC at billing width59746-0050Add 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
59746-050-22	59746005022	7 BLISTER PACK in 1 CARTON (59746-050-22) / 4 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACKMarketed from Nov 4, 2011

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, Orally disintegrating
Route: Oral
Labeler: Jubilant Cadista Pharmacuticals Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 090839
Marketing start: Nov 4, 2011
Listing expires: Dec 31, 2026
Identifiers: Product ID 59746-050_90b80768-87f7-4fb1-8142-909dba9555e2SPL ID 90b80768-87f7-4fb1-8142-909dba9555e2SPL set ID 739dcf8a-ed73-5eb0-899b-7e51cb73c335RxCUI 401953, 401954, 403825, 616698, 616705UNII L6UH7ZF8HCUPC 0359746020224, 0359746030223, 0359746010324, 0359746040222, 0359746050221
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

N459746005022 followed by a unit qualifier and the quantity

Package 59746-0050-22. 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 Oct 8, 2025. This label includes a boxed warning.

Indications (excerpt from the label)

Risperidone orally disintegrating tablets are 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)

Other NDCs under ANDA 090839

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

FDA NDC Directory listings under ANDA 090839
Product	Strength	Form · route	Labeler	Product NDC
Risperidone	Risperidone .5 mg/1	Tablet, Orally disintegratingOral	Jubilant Cadista Pharmacuticals Inc.	59746-010
Risperidone	Risperidone 3 mg/1	Tablet, Orally disintegratingOral	Jubilant Cadista Pharmacuticals Inc.	59746-040
Risperidone	Risperidone 1 mg/1	Tablet, Orally disintegratingOral	Jubilant Cadista Pharmacuticals Inc.	59746-020
Risperidone	Risperidone 2 mg/1	Tablet, Orally disintegratingOral	Jubilant Cadista Pharmacuticals Inc.	59746-030