Prescription drug · NDA
Risperdal Consta (Risperidone) NDC 50458-308
Kit · Janssen Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50458-308-11 | 5045803081150458030811 | 1 KIT in 1 BOX (50458-308-11) * 2 mL in 1 VIAL * 2 mL in 1 SYRINGE (50458-308-01)Marketed from Oct 29, 2003 |
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)
- Risperdal Consta
- Generic name (nonproprietary)
- risperidone
- Dosage form
- Kit
- Labeler
- Janssen Pharmaceuticals, Inc.NDC labeler code 50458
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 021346
- Marketing start
- Listing expires
- Identifiers
- Product ID 50458-308_42dc490b-4117-142a-e063-6294a90aeb21SPL ID 42dc490b-4117-142a-e063-6294a90aeb21SPL set ID bb34ee82-d2c2-43b8-ba21-2825c0954691RxCUI 402010, 402011, 402012, 706822, 706825, 706827, 706829, 706831
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 drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.
- NDC on a medical claim
N450458030811followed by a unit qualifier and the quantityPackage 50458-0308-11. 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)
RISPERDAL CONSTA is an atypical antipsychotic indicated: for the treatment of schizophrenia. ( 1.1 ) as monotherapy or as adjunctive therapy to lithium or valproate for the maintenance treatment of Bipolar I Disorder. ( 1.2 ) 1.1 Schizophrenia RISPERDAL CONSTA (risperidone) is indicated for the treatment of schizophrenia [see Clinical Studies (14.1) ]. 1.2 Bipolar Disorder RISPERDAL CONSTA is indicated as monotherapy or as adjunctive therapy to lithium or valproate for the maintenance treatment of Bipolar I Disorder [see Clinical Studies (14.2 , 14.3) ] .
Excerpt only. Read the full label for complete information.
About NDC 50458-308
- What is NDC 50458-308?
- 50458-308 is the product NDC for Risperdal Consta (risperidone) kit, listed with the FDA by Janssen Pharmaceuticals, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Risperdal Consta (Risperidone).
- Who is the labeler?
- Janssen Pharmaceuticals, Inc., NDC labeler code 50458. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Risperdal Consta?
- 3 other product NDCs are listed under this name. See all Risperdal Consta NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Risperdal Consta products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Risperdal Constarisperidone | — | Kit | Janssen Pharmaceuticals, Inc. | 50458-306 | 50458-0306-11 |
| Risperdal Constarisperidone | — | Kit | Janssen Pharmaceuticals, Inc. | 50458-307 | 50458-0307-11 |
| Risperdal Constarisperidone | — | Kit | Janssen Pharmaceuticals, Inc. | 50458-309 | 50458-0309-11 |
Other NDCs under NDA 021346
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 |
|---|---|---|---|---|
| Risperdal Constarisperidone | — | Kit | Janssen Pharmaceuticals, Inc. | 50458-306 |
| Risperdal Constarisperidone | — | Kit | Janssen Pharmaceuticals, Inc. | 50458-307 |
| Risperdal Constarisperidone | — | Kit | Janssen Pharmaceuticals, Inc. | 50458-309 |