Risperidone
- Product NDC
- 42291-912
- 11-digit product format
- 422910912
- Labeler code
- 42291
- Product ID
- 42291-912_48ec0cc0-9916-db6b-e063-6294a90a4bea
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Risperidone
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- AvKARE
- Application
- ANDA078071
- Marketing category
- ANDA
- Marketing start
- 2021-09-10
- Substance
- RISPERIDONE
- Active strength
- 3 mg/1
- 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 | 3 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | L6UH7ZF8HC |
| Rxcui | 312828, 312829, 312830, 312831, 312832, 314211 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 42291-912-50 | Risperidone | 500 in 1 BOTTLE | TABLET | 500 | | 4 |
| 42291-912-60 | Risperidone | 60 in 1 BOTTLE | TABLET | 60 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 42291-912 | RISPERIDONE TABLET [AVKARE] | 3 | Current NDC, Legacy NDC, 1 package rows | 20230111_cc97c0d4-4690-62be-e053-2a95a90a3a0c.zip |
| 42291-912 | RISPERIDONE TABLET [AVKARE] | 2 | Current NDC, Legacy NDC, 1 package rows | 20230111_cba7628c-30b2-5d26-e053-2a95a90a3e57.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 |
|---|
| 42291-912-50 | 42291091250 | 500 TABLET in 1 BOTTLE (42291-912-50) | 500 tablet | 2021-09-10 | 0000-00-00 | No | No | Current |
| 42291-912-60 | 42291091260 | 60 TABLET in 1 BOTTLE (42291-912-60) | 60 tablet | 2021-09-22 | 0000-00-00 | No | No | Current |