risperidone
- Product NDC
- 65841-665
- 11-digit product format
- 658410665
- Labeler code
- 65841
- Product ID
- 65841-665_d39bd21c-64bb-4eff-8713-5a5ed9b98c9d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- risperidone
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Zydus Lifesciences Limited
- Application
- ANDA078040
- Marketing category
- ANDA
- Marketing start
- 2008-11-13
- Substance
- RISPERIDONE
- Active strength
- .25 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 | .25 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 |
|---|
| 65841-665-01 | risperidone | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | | 9 |
| 65841-665-05 | risperidone | 500 in 1 BOTTLE | TABLET, FILM COATED | 500 | | 9 |
| 65841-665-06 | risperidone | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 9 |
| 65841-665-10 | risperidone | 1000 in 1 BOTTLE | TABLET, FILM COATED | 1000 | | 9 |
| 65841-665-14 | risperidone | 60 in 1 BOTTLE | TABLET, FILM COATED | 60 | | 9 |
| 65841-665-16 | risperidone | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 9 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| RISPERIDONE | ACTIVE INGREDIENT | L6UH7ZF8HC | RISPERIDONE TABLET, FILM COATED [CADILA HEALTHCARE LIMITED] | 3 | |
| RISPERIDONE | ACTIVE MOIETY | L6UH7ZF8HC | RISPERIDONE TABLET, FILM COATED [CADILA HEALTHCARE LIMITED] | 3 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | RISPERIDONE TABLET, FILM COATED [CADILA HEALTHCARE LIMITED] | 3 | |
| D&C YELLOW NO. 10 | INACTIVE INGREDIENT | 35SW5USQ3G | RISPERIDONE TABLET, FILM COATED [CADILA HEALTHCARE LIMITED] | 3 | |
| FD&C BLUE NO. 2 | INACTIVE INGREDIENT | L06K8R7DQK | RISPERIDONE TABLET, FILM COATED [CADILA HEALTHCARE LIMITED] | 3 | |
| FD&C YELLOW NO. 6 | INACTIVE INGREDIENT | H77VEI93A8 | RISPERIDONE TABLET, FILM COATED [CADILA HEALTHCARE LIMITED] | 3 | |
| FERRIC OXIDE RED | INACTIVE INGREDIENT | 1K09F3G675 | RISPERIDONE TABLET, FILM COATED [CADILA HEALTHCARE LIMITED] | 3 | |
| FERRIC OXIDE YELLOW | INACTIVE INGREDIENT | EX438O2MRT | RISPERIDONE TABLET, FILM COATED [CADILA HEALTHCARE LIMITED] | 3 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | RISPERIDONE TABLET, FILM COATED [CADILA HEALTHCARE LIMITED] | 3 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | RISPERIDONE TABLET, FILM COATED [CADILA HEALTHCARE LIMITED] | 3 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | RISPERIDONE TABLET, FILM COATED [CADILA HEALTHCARE LIMITED] | 3 | |
| PROPYLENE GLYCOL | INACTIVE INGREDIENT | 6DC9Q167V3 | RISPERIDONE TABLET, FILM COATED [CADILA HEALTHCARE LIMITED] | 3 | |
| SODIUM LAURYL SULFATE | INACTIVE INGREDIENT | 368GB5141J | RISPERIDONE TABLET, FILM COATED [CADILA HEALTHCARE LIMITED] | 3 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | RISPERIDONE TABLET, FILM COATED [CADILA HEALTHCARE LIMITED] | 3 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | RISPERIDONE TABLET, FILM COATED [CADILA HEALTHCARE LIMITED] | 3 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 65841-665 | RISPERIDONE TABLET, FILM COATED [ZYDUS LIFESCIENCES LIMITED] | 9 | Current NDC, Legacy NDC, 6 package rows | 20240815_23993d21-80bf-41c4-b57d-88a620173b6b.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 65841-665-01 | 65841066501 | 100 TABLET, FILM COATED in 1 BOTTLE (65841-665-01) | 2008-11-13 | 0000-00-00 | No | No | Current |
| 65841-665-05 | 65841066505 | 500 TABLET, FILM COATED in 1 BOTTLE (65841-665-05) | 2008-11-13 | 0000-00-00 | No | No | Current |
| 65841-665-06 | 65841066506 | 30 TABLET, FILM COATED in 1 BOTTLE (65841-665-06) | 2008-11-13 | 0000-00-00 | No | No | Current |
| 65841-665-10 | 65841066510 | 1000 TABLET, FILM COATED in 1 BOTTLE (65841-665-10) | 2008-11-13 | 0000-00-00 | No | No | Current |
| 65841-665-14 | 65841066514 | 60 TABLET, FILM COATED in 1 BOTTLE (65841-665-14) | 2008-11-13 | 0000-00-00 | No | No | Current |
| 65841-665-16 | 65841066516 | 90 TABLET, FILM COATED in 1 BOTTLE (65841-665-16) | 2008-11-13 | 0000-00-00 | No | No | Current |