Risperidone
- Product NDC
- 50458-596
- 11-digit product format
- 504580596
- Labeler code
- 50458
- Product ID
- 50458-596_3b408b5f-285c-68a9-e063-6294a90ad609
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- risperidone
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- Janssen Pharmaceutical, Inc.
- Application
- NDA020588
- Marketing category
- NDA
- Marketing start
- 1996-06-10
- Substance
- RISPERIDONE
- Active strength
- 1 mg/mL
- Pharmacologic classes
- Atypical Antipsychotic [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Risperidone
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| RISPERIDONE | 1 mg/mL |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | L6UH7ZF8HC |
| Rxcui | 199387, 312829, 312830, 312831, 312832, 314211, 401953, 401954, 403825, 616698, 616705 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 6ab2126a-0ca2-c16c-ab6d-b3a031ba7ac6 | Product name | 5 | 20250303 |
| 0efa9fd6-2fb6-4cd3-8b0f-2a2bf9c4a09e | Product name | 1 | 20250128 |
| e457a910-2c3a-4bfd-90b9-0310982c50dd | Product name | 1 | 20241218 |
| 42b1a2d5-888a-4386-ab9f-0979e0d7b4aa | Product name | 1 | 20231010 |
| 66685e90-862d-4873-a0c5-2be73b803c36 | Product name | 1 | 20230921 |
| 92d220a1-2a4c-4393-9080-7335ca8223cc | Product name | 1 | 20230823 |
| c6f86816-7da6-43ea-8c25-ac9758311cc5 | Product name | 1 | 20220118 |
| f52be47f-7aa7-46c0-b1fa-50c18dd50206 | Product name | 1 | 20201029 |
| 252e11b6-1a9a-4283-a242-df2c129c496d | Product name | 3 | 20170717 |
| 0ca1d589-929b-4b33-bc5b-1d84abdafa6a | Product name | 1 | 20150324 |
| fc363c46-397b-4476-ac0f-70e43e8e4592 | Product name | 1 | 20150324 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 50458-596-01 | Risperidone | 30 mL in 1 BOTTLE | SOLUTION | 30 | 33 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 50458-596-01 | ML - Milliliter | 50458-596 | 8d38ac9c-8c4f-42bf-b9ef-604ace482fd0 | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 50458-596 | RISPERIDONE TABLET RISPERIDONE SOLUTION RISPERIDONE M-TAB (RISPERIDONE) TABLET, ORALLY DISINTEGRATING [JANSSEN PHARMACEUTICAL, INC.] | 32 | Current NDC, Legacy NDC, 1 package rows | 20250302_701e1cd8-2868-4d29-85a9-a2212c88165f.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 403825 | risperiDONE 0.5 MG Disintegrating Oral Tablet | PSN | 701e1cd8-2868-4d29-85a9-a2212c88165f | 33 |
| 312829 | risperiDONE 0.5 MG Oral Tablet | PSN | 701e1cd8-2868-4d29-85a9-a2212c88165f | 33 |
| 401953 | risperiDONE 1 MG Disintegrating Oral Tablet | PSN | 701e1cd8-2868-4d29-85a9-a2212c88165f | 33 |
| 199387 | risperiDONE 1 MG in 1 mL Oral Solution | PSN | 701e1cd8-2868-4d29-85a9-a2212c88165f | 33 |
| 312830 | risperiDONE 1 MG Oral Tablet | PSN | 701e1cd8-2868-4d29-85a9-a2212c88165f | 33 |
| 401954 | risperiDONE 2 MG Disintegrating Oral Tablet | PSN | 701e1cd8-2868-4d29-85a9-a2212c88165f | 33 |
| 312831 | risperiDONE 2 MG Oral Tablet | PSN | 701e1cd8-2868-4d29-85a9-a2212c88165f | 33 |
| 616698 | risperiDONE 3 MG Disintegrating Oral Tablet | PSN | 701e1cd8-2868-4d29-85a9-a2212c88165f | 33 |
| 312832 | risperiDONE 3 MG Oral Tablet | PSN | 701e1cd8-2868-4d29-85a9-a2212c88165f | 33 |
| 616705 | risperiDONE 4 MG Disintegrating Oral Tablet | PSN | 701e1cd8-2868-4d29-85a9-a2212c88165f | 33 |
| 314211 | risperiDONE 4 MG Oral Tablet | PSN | 701e1cd8-2868-4d29-85a9-a2212c88165f | 33 |
| 403825 | risperidone 0.5 MG Disintegrating Oral Tablet | SCD | 701e1cd8-2868-4d29-85a9-a2212c88165f | 33 |
| 312829 | risperidone 0.5 MG Oral Tablet | SCD | 701e1cd8-2868-4d29-85a9-a2212c88165f | 33 |
| 401953 | risperidone 1 MG Disintegrating Oral Tablet | SCD | 701e1cd8-2868-4d29-85a9-a2212c88165f | 33 |
| 312830 | risperidone 1 MG Oral Tablet | SCD | 701e1cd8-2868-4d29-85a9-a2212c88165f | 33 |
| 199387 | risperidone 1 MG/ML Oral Solution | SCD | 701e1cd8-2868-4d29-85a9-a2212c88165f | 33 |
| 401954 | risperidone 2 MG Disintegrating Oral Tablet | SCD | 701e1cd8-2868-4d29-85a9-a2212c88165f | 33 |
| 312831 | risperidone 2 MG Oral Tablet | SCD | 701e1cd8-2868-4d29-85a9-a2212c88165f | 33 |
| 616698 | risperidone 3 MG Disintegrating Oral Tablet | SCD | 701e1cd8-2868-4d29-85a9-a2212c88165f | 33 |
| 312832 | risperidone 3 MG Oral Tablet | SCD | 701e1cd8-2868-4d29-85a9-a2212c88165f | 33 |
| 616705 | risperidone 4 MG Disintegrating Oral Tablet | SCD | 701e1cd8-2868-4d29-85a9-a2212c88165f | 33 |
| 314211 | risperidone 4 MG Oral Tablet | SCD | 701e1cd8-2868-4d29-85a9-a2212c88165f | 33 |
| 199387 | risperidone 1 MG per 1 ML Oral Solution | SY | 701e1cd8-2868-4d29-85a9-a2212c88165f | 33 |
| 199387 | risperiDONE 1 MG in 1 mL Oral Solution | PSN | ab1cf6fd-9932-47fc-8736-476cc53a13fa | 5 |
| 199387 | risperidone 1 MG/ML Oral Solution | SCD | ab1cf6fd-9932-47fc-8736-476cc53a13fa | 5 |
| 199387 | risperidone 1 MG per 1 ML Oral Solution | SY | ab1cf6fd-9932-47fc-8736-476cc53a13fa | 5 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 50458-596-01 | 50458059601 | 30 mL in 1 BOTTLE (50458-596-01) | 30 ml | 1996-06-10 | 0000-00-00 | No | No | Current |