Prescription drug · ANDA
Risperidone NDC 13668-036
Risperidone .5 mg/1 · Tablet · Oral · Torrent Pharmaceuticals Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 13668-036-01 | 1366800360113668003601 | 100 TABLET in 1 BOTTLE (13668-036-01)Marketed from Jan 1, 2009 | |
| 13668-036-05 | 1366800360513668003605 | 500 TABLET in 1 BOTTLE (13668-036-05)Marketed from Jan 1, 2009 | |
| 13668-036-30 | 1366800363013668003630 | 30 TABLET in 1 BOTTLE (13668-036-30)Marketed from Jan 1, 2009 | |
| 13668-036-54 | 1366800365413668003654 | 8500 TABLET in 1 BOTTLE (13668-036-54)Marketed from Jan 1, 2009 | |
| 13668-036-60 | 1366800366013668003660 | 60 TABLET in 1 BOTTLE (13668-036-60)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 — .5 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Torrent Pharmaceuticals LimitedNDC labeler code 13668
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 079088
- Marketing start
- Listing expires
- Identifiers
- Product ID 13668-036_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
N413668003601followed by a unit qualifier and the quantityPackage 13668-0036-01. 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 . 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.
About NDC 13668-036
- What is NDC 13668-036?
- 13668-036 is the product NDC for Risperidone, Risperidone .5 mg/1 tablet, listed with the FDA by Torrent Pharmaceuticals Limited. It has 5 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?
- Torrent Pharmaceuticals Limited, NDC labeler code 13668. 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.
Related NDCs: other Risperidone products
Other finished products listed under the same name: strengths, forms and labelers.
| 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 |
Other NDCs under ANDA 079088
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Risperidone | Risperidone .25 mg/1 | TabletOral | Torrent Pharmaceuticals Limited | 13668-035 |
| Risperidone | Risperidone 1 mg/1 | TabletOral | Torrent Pharmaceuticals Limited | 13668-037 |
| Risperidone | Risperidone 2 mg/1 | TabletOral | Torrent Pharmaceuticals Limited | 13668-038 |
| Risperidone | Risperidone 3 mg/1 | TabletOral | Torrent Pharmaceuticals Limited | 13668-039 |
| Risperidone | Risperidone 4 mg/1 | TabletOral | Torrent Pharmaceuticals Limited | 13668-040 |
| Risperidone | Risperidone 1 mg/1 | TabletOral | PD-Rx Pharmaceuticals, Inc. | 43063-254 |