Risperidone
- Product NDC
- 69238-2109
- 11-digit product format
- 692382109
- Labeler code
- 69238
- Product ID
- 69238-2109_a852094f-1084-4916-a185-e7ea35080780
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Risperidone
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Amneal Pharmaceuticals NY LLC
- Application
- ANDA078071
- Marketing category
- ANDA
- Marketing start
- 2021-08-01
- Substance
- RISPERIDONE
- Active strength
- .5 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 table| Ingredient | Strength |
|---|
| RISPERIDONE | .5 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | L6UH7ZF8HC |
| Rxcui | 312828, 312829, 312830, 312831, 312832, 314211 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 69238-2109-5 | Risperidone | 500 in 1 BLISTER PACK | TABLET | 500 | | 6 |
| 69238-2109-6 | Risperidone | 60 in 1 BOTTLE | TABLET | 60 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 69238-2109 | RISPERIDONE TABLET [AMNEAL PHARMACEUTICALS NY LLC] | 6 | Current NDC, Legacy NDC, 2 package rows | 20250223_e90c886c-132a-4df6-8604-cfe5ffa49d5b.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 |
|---|
| 69238-2109-5 | 69238210905 | 500 TABLET in 1 BLISTER PACK (69238-2109-5) | 500 tablet | 2021-08-01 | 0000-00-00 | No | No | Current |
| 69238-2109-6 | 69238210906 | 60 TABLET in 1 BOTTLE (69238-2109-6) | 60 tablet | 2021-08-01 | 0000-00-00 | No | No | Current |