Risperidone
- Product NDC
- 69339-182
- 11-digit product format
- 693390182
- Labeler code
- 69339
- Product ID
- 69339-182_856d65dc-f330-4195-b271-d0bdbe99519d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Risperidone
- Dosage form
- TABLET, ORALLY DISINTEGRATING
- Route
- ORAL
- Labeler
- Natco Pharma USA LLC
- Application
- ANDA091537
- Marketing category
- ANDA
- Marketing start
- 2023-10-14
- Substance
- RISPERIDONE
- Active strength
- .5 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 | .5 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | L6UH7ZF8HC |
| Rxcui | 401953, 401954, 403825, 616698, 616705, 645037 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 69339-182-03 | Risperidone | 30 in 1 BOTTLE | TABLET, ORALLY DISINTEGRATING | 30 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 69339-182 | RISPERIDONE TABLET, ORALLY DISINTEGRATING [NATCO PHARMA USA LLC] | 1 | Current NDC, 1 package rows | 20231122_856d65dc-f330-4195-b271-d0bdbe99519d.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 69339-182-03 | 69339018203 | 30 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (69339-182-03) | 2023-10-14 | No | No | Current |