Risperidone
- Product NDC
- 70121-2627
- 11-digit product format
- 701212627
- Labeler code
- 70121
- Product ID
- 70121-2627_1109da94-12c2-4378-b9fb-74f94382b90a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- risperidone
- Dosage form
- KIT
- Route
- INTRAMUSCULAR
- 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 |
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| L6UH7ZF8HC | RISPERIDONE | 106266-06-2 | risperidone |
Packages
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 70121-2627-5 | 70121262705 | 1 KIT in 1 CARTON (70121-2627-5) * 2 mL in 1 VIAL (70121-1352-1) * 2 mL in 1 SYRINGE (70121-2624-2) | 1 kit | 2025-09-08 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Risperidone | Amneal Pharmaceuticals LLC | Amneal Pharmaceuticals Private Limited | 2025-07-06 | HUMAN PRESCRIPTION DRUG LABEL | 6 |