Risperidone
- Product NDC
- 13668-039
- 11-digit product format
- 136680039
- Labeler code
- 13668
- Product ID
- 13668-039_cd8bfb14-7054-4c69-b27f-8a960b5ecb5f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Risperidone
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Torrent Pharmaceuticals Limited
- Application
- ANDA079088
- Marketing category
- ANDA
- Marketing start
- 2009-01-01
- 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#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 13668-039-01 | Risperidone | 100 in 1 BOTTLE | TABLET | 100 | | 25 |
| 13668-039-05 | Risperidone | 500 in 1 BOTTLE | TABLET | 500 | | 25 |
| 13668-039-56 | Risperidone | 2750 in 1 BOTTLE | TABLET | 2750 | | 25 |
| 13668-039-60 | Risperidone | 60 in 1 BOTTLE | TABLET | 60 | | 25 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 13668-039 | RISPERIDONE TABLET [TORRENT PHARMACEUTICALS LIMITED] | 24 | Current NDC, Legacy NDC, 4 package rows | 20250227_a6347895-5f16-43b4-92a0-b9904ac81937.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 |
|---|
| 13668-039-01 | 13668003901 | 100 TABLET in 1 BOTTLE (13668-039-01) | 100 tablet | 2009-01-01 | 0000-00-00 | No | No | Current |
| 13668-039-05 | 13668003905 | 500 TABLET in 1 BOTTLE (13668-039-05) | 500 tablet | 2009-01-01 | 0000-00-00 | No | No | Current |
| 13668-039-56 | 13668003956 | 2750 TABLET in 1 BOTTLE (13668-039-56) | 2750 tablet | 2009-01-01 | 0000-00-00 | No | No | Current |
| 13668-039-60 | 13668003960 | 60 TABLET in 1 BOTTLE (13668-039-60) | 60 tablet | 2009-01-01 | 0000-00-00 | No | No | Current |
| 13668-039-74 | 13668003974 | 100 TABLET in 1 CARTON (13668-039-74) | 100 tablet | 2009-01-01 | 0000-00-00 | No | No | Current |