Risperidone
- Product NDC
- 0615-8196
- 11-digit product format
- 006158196
- Labeler code
- 0615
- Product ID
- 0615-8196_102140c8-c00e-4498-8e1a-322d5de68198
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Risperidone
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- NCS HealthCare of KY, LLC dba Vangard Labs
- Application
- ANDA077493
- Marketing category
- ANDA
- Marketing start
- 2015-06-01
- 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 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0615-8196-05 | Risperidone | 15 in 1 BLISTER PACK | TABLET | 15 | | 13 |
| 0615-8196-30 | Risperidone | 5 in 1 BLISTER PACK | TABLET | 5 | | 13 |
| 0615-8196-30 | Risperidone | 6 in 1 BOX, UNIT-DOSE | TABLET | 6 | | 13 |
| 0615-8196-39 | Risperidone | 30 in 1 BLISTER PACK | TABLET | 30 | | 13 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0615-8196 | RISPERIDONE TABLET [NCS HEALTHCARE OF KY, LLC DBA VANGARD LABS] | 13 | Current NDC, Legacy NDC, 4 package rows | 20230301_7bbc37f1-6d6a-4021-8976-1f103ce1cfbd.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 |
|---|
| 0615-8196-05 | 00615819605 | 15 TABLET in 1 BLISTER PACK (0615-8196-05) | 15 tablet | 2018-02-02 | 0000-00-00 | No | No | Current |
| 0615-8196-30 | 00615819630 | 6 BLISTER PACK in 1 BOX, UNIT-DOSE (0615-8196-30) > 5 TABLET in 1 BLISTER PACK | 6 blister pack | 2018-02-01 | 0000-00-00 | No | No | Current |
| 0615-8196-39 | 00615819639 | 30 TABLET in 1 BLISTER PACK (0615-8196-39) | 30 tablet | 2018-02-02 | 0000-00-00 | No | No | Current |