Risperidone
- Product NDC
- 42291-978
- 11-digit product format
- 422910978
- Labeler code
- 42291
- Product ID
- 42291-978_3d4c5818-d71d-e4d0-e063-6394a90a9679
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Risperidone
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- AvKARE
- Application
- ANDA078707
- Marketing category
- ANDA
- Marketing start
- 2025-08-27
- Substance
- RISPERIDONE
- Active strength
- 3 mg/1
- 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
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| RISPERIDONE | 3 mg/1 |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | L6UH7ZF8HC |
| Rxcui | 312831, 312832, 314211 |
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 |
| 362d7abb-94e6-4c60-9a58-266894157713 | Product name | 1 | 20231023 |
| 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 |
| 816b97af-edc5-4060-aff1-b814bdbcad50 | Product name | 1 | 20190415 |
| 419aab54-5d5a-4146-9453-026d4a9991be | Product name | 2 | 20170525 |
| 89dac932-b90a-4410-9ab1-84c53e57de25 | Product name | 1 | 20150316 |
| d723478e-ad4a-ec23-6bd7-cfe33e1e3840 | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 42291-978-50 | Risperidone | 500 in 1 BOTTLE | TABLET, FILM COATED | 500 | 1 | |
| 42291-978-60 | Risperidone | 60 in 1 BOTTLE | TABLET, FILM COATED | 60 | 1 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 42291-978-50 | EA - Each | 42291-978 | c2db57e4-f2ce-40db-a09b-d08018387a07 | 1 | 2025-10-14 |
| 42291-978-60 | EA - Each | 42291-978 | 8c8be576-19df-445d-80d2-e621ac03c0f8 | 1 | 2025-10-14 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 312831 | risperiDONE 2 MG Oral Tablet | PSN | 3d4c51e2-b09b-9fd0-e063-6294a90ae699 | 1 |
| 312832 | risperiDONE 3 MG Oral Tablet | PSN | 3d4c51e2-b09b-9fd0-e063-6294a90ae699 | 1 |
| 314211 | risperiDONE 4 MG Oral Tablet | PSN | 3d4c51e2-b09b-9fd0-e063-6294a90ae699 | 1 |
| 312831 | risperidone 2 MG Oral Tablet | SCD | 3d4c51e2-b09b-9fd0-e063-6294a90ae699 | 1 |
| 312832 | risperidone 3 MG Oral Tablet | SCD | 3d4c51e2-b09b-9fd0-e063-6294a90ae699 | 1 |
| 314211 | risperidone 4 MG Oral Tablet | SCD | 3d4c51e2-b09b-9fd0-e063-6294a90ae699 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|
| 42291-978-50 | 42291097850 | 500 TABLET, FILM COATED in 1 BOTTLE (42291-978-50) | 2025-08-27 | No | No | Current |
| 42291-978-60 | 42291097860 | 60 TABLET, FILM COATED in 1 BOTTLE (42291-978-60) | 2025-08-27 | No | No | Current |