Risperidone
- Product NDC
- 43547-340
- 11-digit product format
- 435470340
- Labeler code
- 43547
- Product ID
- 43547-340_96d2f276-6bf9-4dfd-8831-888ca0c5c5b0
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Risperidone
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Solco Healthcare US, LLC
- Application
- ANDA077493
- Marketing category
- ANDA
- Marketing start
- 2014-06-01
- Substance
- RISPERIDONE
- Active strength
- .5 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 | .5 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | L6UH7ZF8HC |
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 |
|---|
| 43547-340-06 | Risperidone | 60 in 1 BOTTLE | TABLET | 60 | | 14 |
| 43547-340-50 | Risperidone | 500 in 1 BOTTLE | TABLET | 500 | | 14 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 43547-340 | RISPERIDONE TABLET [SOLCO HEALTHCARE US, LLC] | 13 | Current NDC, Legacy NDC, 2 package rows | 20250328_43aa2a4f-1123-4f86-800b-9218882f7bcd.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 |
|---|
| 43547-340-06 | 43547034006 | 60 TABLET in 1 BOTTLE (43547-340-06) | 60 tablet | 2014-06-01 | 0000-00-00 | No | No | Current |
| 43547-340-50 | 43547034050 | 500 TABLET in 1 BOTTLE (43547-340-50) | 500 tablet | 2014-06-01 | 0000-00-00 | No | No | Current |