Risperidone
- Product NDC
- 65162-673
- 11-digit product format
- 651620673
- Labeler code
- 65162
- Product ID
- 65162-673_bdd3de74-828c-406b-a179-343b4c24d1d3
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Risperidone
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- Amneal Pharmaceuticals LLC
- Application
- ANDA091384
- Marketing category
- ANDA
- Marketing start
- 2011-05-31
- 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
- 2026-12-31
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 |
|---|
| 65162-673-84 | Risperidone | 30 mL in 1 BOTTLE | SOLUTION | 30 | | 23 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 65162-673 | RISPERIDONE SOLUTION [AMNEAL PHARMACEUTICALS LLC] | 22 | Current NDC, Legacy NDC, 1 package rows | 20250223_bc55f60a-8121-44bb-bdfc-1d311879ba4f.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 65162-673-84 | 65162067384 | 30 mL in 1 BOTTLE (65162-673-84) | 30 ml | 2011-05-31 | 0000-00-00 | No | No | Current |