RISPERIDONE
- Product NDC
- 43063-908
- 11-digit product format
- 430630908
- Labeler code
- 43063
- Product ID
- 43063-908_32d6d5a1-fa47-3097-e063-6294a90ac4e0
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- RISPERIDONE
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- PD-Rx Pharmaceuticals, Inc.
- Application
- ANDA201003
- Marketing category
- ANDA
- Marketing start
- 2014-03-28
- Substance
- RISPERIDONE
- Active strength
- 1 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 | 1 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | L6UH7ZF8HC |
| Rxcui | 312830 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 43063-908-07 | RISPERIDONE | 7 in 1 BOTTLE, PLASTIC | TABLET | 7 | | 20 |
| 43063-908-30 | RISPERIDONE | 30 in 1 BOTTLE, PLASTIC | TABLET | 30 | | 20 |
| 43063-908-60 | RISPERIDONE | 60 in 1 BOTTLE, PLASTIC | TABLET | 60 | | 20 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 43063-908 | RISPERIDONE TABLET [PD-RX PHARMACEUTICALS, INC.] | 20 | Current NDC, Legacy NDC, 3 package rows | 20250417_be388943-fe0c-4c82-ac8e-3df9f77b2891.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 |
|---|
| 43063-908-07 | 43063090807 | 7 TABLET in 1 BOTTLE, PLASTIC (43063-908-07) | 7 tablet | 2022-08-11 | 0000-00-00 | No | No | Current |
| 43063-908-30 | 43063090830 | 30 TABLET in 1 BOTTLE, PLASTIC (43063-908-30) | 30 tablet | 2018-11-27 | 0000-00-00 | No | No | Current |
| 43063-908-60 | 43063090860 | 60 TABLET in 1 BOTTLE, PLASTIC (43063-908-60) | 60 tablet | 2018-11-27 | 0000-00-00 | No | No | Current |