Risperidone
- Product NDC
- 62559-981
- 11-digit product format
- 625590981
- Labeler code
- 62559
- Product ID
- 62559-981_2c44590a-6811-49fb-8cef-de7dc5bc6164
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Risperidone
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- ANI Pharmaceuticals, Inc.
- Application
- ANDA076440
- Marketing category
- ANDA
- Marketing start
- 2025-10-27
- Substance
- RISPERIDONE
- Active strength
- 1 mg/mL
- Pharmacologic classes
- Atypical Antipsychotic [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Risperidone
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| RISPERIDONE | 1 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | L6UH7ZF8HC |
| Rxcui | 199387 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 62559-981-30 | Risperidone | 30 mL in 1 BOTTLE | SOLUTION | 30 | | 2 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 62559-981-30 | 62559098130 | 30 mL in 1 BOTTLE (62559-981-30) | 30 ml | 2025-10-27 | No | No | Historical |