Risperidone
- Product NDC
- 70518-3760
- 11-digit product format
- 705183760
- Labeler code
- 70518
- Product ID
- 70518-3760_4f8356fa-4c24-9f88-e063-6294a90a09d6
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- risperidone
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- REMEDYREPACK INC.
- Application
- NDA020588
- Marketing category
- NDA
- Marketing start
- 2023-06-12
- Substance
- RISPERIDONE
- Active strength
- 1 mg/mL
- 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 | 1 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | L6UH7ZF8HC |
| Rxcui | 199387 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 70518-3760-0 | Risperidone | 10 in 1 BOX | SOLUTION | 10 | | 5 |
| 70518-3760-1 | Risperidone | 2 mL in 1 CUP, UNIT-DOSE | SOLUTION | 2 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70518-3760 | RISPERIDONE SOLUTION [REMEDYREPACK INC.] | 2 | Current NDC, 2 package rows | 20240331_ab1cf6fd-9932-47fc-8736-476cc53a13fa.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 |
|---|
| 70518-3760-0 | 70518376000 | 10 CUP, UNIT-DOSE in 1 BOX (70518-3760-0) / 2 mL in 1 CUP, UNIT-DOSE (70518-3760-1) | | 2023-06-12 | No | No | Historical |
| 70518-3760-1 | 70518376001 | 2 mL in 1 CUP, UNIT-DOSE | 2 ml | | | | Historical |