risperidone
- Product NDC
- 0904-7365
- 11-digit product format
- 009047365
- Labeler code
- 0904
- Product ID
- 0904-7365_41d98aaf-a69e-414d-af3f-2c815cd1f43a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- risperidone
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Major Pharmaceuticals
- Application
- ANDA078040
- Marketing category
- ANDA
- Marketing start
- 2008-11-13
- Substance
- RISPERIDONE
- Active strength
- 4 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 | 4 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 |
|---|
| 0904-7365-61 | risperidone | 1 in 1 BLISTER PACK | TABLET, FILM COATED | 1 | | 4 |
| 0904-7365-61 | risperidone | 100 in 1 CARTON | TABLET, FILM COATED | 100 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0904-7365 | RISPERIDONE TABLET, FILM COATED [MAJOR PHARMACEUTICALS] | 3 | Current NDC, 2 package rows | 20250509_d5abd75f-7f4a-4a7d-b849-82fce88f5ff7.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 0904-7365-61 | 00904736561 | 100 BLISTER PACK in 1 CARTON (0904-7365-61) / 1 TABLET, FILM COATED in 1 BLISTER PACK | 100 blister pack | 2023-10-27 | No | No | Current |