Prescription drug · ANDA
Risperidone NDC 49884-315
Risperidone 1 mg/1 · Tablet, Orally disintegrating · Oral · Par Health USA, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 49884-315-55 | 49884031555 | 5 BLISTER PACK in 1 CARTON (49884-315-55) / 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACKMarketed from Oct 26, 2009 | |
| 49884-315-91 | 49884031591 | 7 BLISTER PACK in 1 CARTON (49884-315-91) / 4 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (49884-315-52)Marketed from Oct 26, 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 — 1 mg/1
- Dosage form
- Tablet, Orally disintegrating
- Route
- Oral
- Labeler
- Par Health USA, LLCNDC labeler code 49884
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 077494
- Marketing start
- Listing expires
- Identifiers
- Product ID 49884-315_9cdd0a9e-9266-49f0-bbf6-73f7285ce144SPL ID 9cdd0a9e-9266-49f0-bbf6-73f7285ce144SPL set ID d0ef6df3-67e5-47b1-bcf7-f67aa030cacaRxCUI 401953, 401954, 403825, 616698, 616705, 645037UNII L6UH7ZF8HCUPC 0349884402525, 0349884315917, 0349884401917, 0349884315528, 0349884401528, 0349884402914, 0349884403522, 0349884311520
- 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
N449884031555followed by a unit qualifier and the quantityPackage 49884-0315-55. 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 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 assoc…
Excerpt only. Read the full label for complete information.
About NDC 49884-315
- What is NDC 49884-315?
- 49884-315 is the product NDC for Risperidone, Risperidone 1 mg/1 tablet, orally disintegrating, listed with the FDA by Par Health USA, LLC. It has 2 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?
- Par Health USA, LLC, NDC labeler code 49884. 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 077494
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 | Tablet, Orally disintegratingOral | Par Health USA, LLC | 49884-212 |
| Risperidone | Risperidone .5 mg/1 | Tablet, Orally disintegratingOral | Par Health USA, LLC | 49884-311 |
| Risperidone | Risperidone 2 mg/1 | Tablet, Orally disintegratingOral | Par Health USA, LLC | 49884-401 |
| Risperidone | Risperidone 3 mg/1 | Tablet, Orally disintegratingOral | Par Health USA, LLC | 49884-402 |
| Risperidone | Risperidone 4 mg/1 | Tablet, Orally disintegratingOral | Par Health USA, LLC | 49884-403 |