RISPERDAL
- Product NDC
- 50458-300
- 11-digit product format
- 504580300
- Labeler code
- 50458
- Product ID
- 50458-300_43556c05-69ec-1276-e063-6294a90a968e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- risperidone
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Janssen Pharmaceuticals, Inc.
- Application
- NDA020272
- Marketing category
- NDA
- Marketing start
- 1993-12-29
- Substance
- RISPERIDONE
- Active strength
- 1 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
- RISPERDAL
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| RISPERIDONE | 1 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | L6UH7ZF8HC |
| Rxcui | 104781, 104782, 104783, 104784, 199387, 211489, 262222, 312829, 312830, 312831, 312832, 314211, 401953, 401954, 403825, 616698, 616705, 630890, 630974, 806297 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 50458-300-01 | RISPERDAL | 10 in 1 BLISTER PACK | TABLET | 10 | | 42 |
| 50458-300-01 | RISPERDAL | 10 in 1 BOX, UNIT-DOSE | TABLET | 10 | | 42 |
| 50458-300-06 | RISPERDAL | 60 in 1 BOTTLE | TABLET | 60 | | 42 |
| 50458-300-50 | RISPERDAL | 500 in 1 BOTTLE | TABLET | 500 | | 42 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 50458-300 | RISPERDAL (RISPERIDONE) TABLET RISPERDAL M-TAB (RISPERIDONE) TABLET, ORALLY DISINTEGRATING RISPERDAL (RISPERIDONE) SOLUTION [JANSSEN PHARMACEUTICALS, INC.] | 40 | Current NDC, Legacy NDC, 4 package rows | 20250228_7e117c7e-02fc-4343-92a1-230061dfc5e0.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 |
|---|
| 50458-300-01 | 50458030001 | 10 BLISTER PACK in 1 BOX, UNIT-DOSE (50458-300-01) / 10 TABLET in 1 BLISTER PACK | 10 blister pack | 1993-12-29 | 0000-00-00 | No | No | Current |
| 50458-300-06 | 50458030006 | 60 TABLET in 1 BOTTLE (50458-300-06) | 60 tablet | 1993-12-29 | 0000-00-00 | No | No | Current |
| 50458-300-50 | 50458030050 | 500 in 1 BOTTLE | | | | | | Historical |