Risperidone
- Product NDC
- 69367-371
- 11-digit product format
- 693670371
- Labeler code
- 69367
- Product ID
- 69367-371_4559701f-b153-5434-e063-6294a90a6d1d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Risperidone
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Westminster Pharmaceuticals, LLC
- Application
- ANDA078707
- Marketing category
- ANDA
- Marketing start
- 2024-09-09
- Substance
- RISPERIDONE
- Active strength
- 2 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 | 2 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 |
|---|
| 69367-371-05 | Risperidone | 500 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 500 | | 6 |
| 69367-371-60 | Risperidone | 60 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 60 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 69367-371 | RISPERIDONE TABLET, FILM COATED [WESTMINSTER PHARMACEUTICALS, LLC] | 5 | Current NDC, 2 package rows | 20250511_07d43bf6-a695-453a-a5c7-9581effe585c.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 69367-371-05 | 69367037105 | 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (69367-371-05) | 2024-09-09 | No | No | Current |
| 69367-371-60 | 69367037160 | 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (69367-371-60) | 2025-04-21 | No | No | Current |