RISPERIDONE
- Product NDC
- 65862-167
- 11-digit product format
- 658620167
- Labeler code
- 65862
- Product ID
- 65862-167_95217dea-1f5b-4645-b55f-09a5d0e6960e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- RISPERIDONE
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- Aurobindo Pharma Limited
- Application
- ANDA078452
- Marketing category
- ANDA
- Marketing start
- 2019-03-25
- 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 |
|---|
| 65862-167-01 | RISPERIDONE | 30 mL in 1 BOTTLE | SOLUTION | 30 | | 23 |
| 65862-167-01 | RISPERIDONE | 1 in 1 CARTON | SOLUTION | 1 | | 23 |
| 65862-167-30 | RISPERIDONE | 1 in 1 CARTON | SOLUTION | 1 | | 23 |
| 65862-167-30 | RISPERIDONE | 30 mL in 1 BOTTLE, GLASS | SOLUTION | 30 | | 23 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 65862-167 | RISPERIDONE SOLUTION [AUROBINDO PHARMA LIMITED] | 23 | Current NDC, Legacy NDC, 4 package rows | 20250308_c4582bdf-5eda-438c-98b4-0517500501e8.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 |
|---|
| 65862-167-01 | 65862016701 | 1 BOTTLE in 1 CARTON (65862-167-01) / 30 mL in 1 BOTTLE | 1 bottle | 2019-03-25 | 0000-00-00 | No | No | Current |
| 65862-167-30 | 65862016730 | 1 BOTTLE, GLASS in 1 CARTON (65862-167-30) / 30 mL in 1 BOTTLE, GLASS | | 2019-03-25 | 0000-00-00 | No | No | Current |