Risperidone
- Product NDC
- 70121-2625
- 11-digit product format
- 701212625
- Labeler code
- 70121
- Product ID
- 70121-2625_1109da94-12c2-4378-b9fb-74f94382b90a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- risperidone
- Dosage form
- KIT
- Route
- SUBCUTANEOUS
- Labeler
- Amneal Pharmaceuticals LLC
- Application
- ANDA218586
- Marketing category
- ANDA
- Marketing start
- 2025-09-08
- 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
Harmonized Identifiers#
| Field | Values |
|---|---|
| Rxcui | 402010, 402011, 402012, 706822 |
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 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 70121-1350-1 | Risperidone | 2 mL in 1 VIAL | INJECTION, POWDER, FOR SUSPENSIO | 2 mL | 12.5 mg in 2mL | 6 |
| 70121-2625-5 | Risperidone | 1 in 1 CARTON | KIT | 1 | 6 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 70121-2625-5 | EA - Each | 70121-2625 | 5aa02550-714b-48c2-b4cc-0c6a7e9971b0 | 1 | 2026-03-17 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 706822 | risperiDONE 12.5 MG Extended Release Injection | PSN | d526af85-ee70-4657-a27e-d451027ffd9e | 6 |
| 402010 | risperiDONE 25 MG Extended Release Injection | PSN | d526af85-ee70-4657-a27e-d451027ffd9e | 6 |
| 402011 | risperiDONE 37.5 MG Extended Release Injection | PSN | d526af85-ee70-4657-a27e-d451027ffd9e | 6 |
| 402012 | risperiDONE 50 MG Extended Release Injection | PSN | d526af85-ee70-4657-a27e-d451027ffd9e | 6 |
| 706822 | risperidone 12.5 MG Injection | SCD | d526af85-ee70-4657-a27e-d451027ffd9e | 6 |
| 402010 | risperidone 25 MG Injection | SCD | d526af85-ee70-4657-a27e-d451027ffd9e | 6 |
| 402011 | risperidone 37.5 MG Injection | SCD | d526af85-ee70-4657-a27e-d451027ffd9e | 6 |
| 402012 | risperidone 50 MG Injection | SCD | d526af85-ee70-4657-a27e-d451027ffd9e | 6 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 70121-1350-1 | 70121135001 | 2 mL in 1 VIAL | 2 ml | Historical | |||
| 70121-2625-5 | 70121262505 | 1 KIT in 1 CARTON (70121-2625-5) * 2 mL in 1 VIAL (70121-1350-1) * 2 mL in 1 SYRINGE (70121-2624-2) | 1 kit | 2025-09-08 | No | No | Current |