RISPERDAL M-TAB
- Product NDC
- 50458-355
- 11-digit product format
- 504580355
- Labeler code
- 50458
- Product ID
- 50458-355_43556c05-69ec-1276-e063-6294a90a968e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- risperidone
- Dosage form
- TABLET, ORALLY DISINTEGRATING
- Route
- ORAL
- Labeler
- Janssen Pharmaceuticals, Inc.
- Application
- NDA021444
- Marketing category
- NDA
- Marketing start
- 2003-04-02
- Substance
- RISPERIDONE
- Active strength
- 4 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 M-TAB
- 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 | 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 |
|---|
| 50458-355-28 | RISPERDAL M-TAB | 7 in 1 BOX | TABLET, ORALLY DISINTEGRATING | 7 | | 42 |
| 50458-355-28 | RISPERDAL M-TAB | 4 in 1 BLISTER PACK | TABLET, ORALLY DISINTEGRATING | 4 | | 42 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 50458-355 | RISPERDAL (RISPERIDONE) TABLET RISPERDAL M-TAB (RISPERIDONE) TABLET, ORALLY DISINTEGRATING RISPERDAL (RISPERIDONE) SOLUTION [JANSSEN PHARMACEUTICALS, INC.] | 40 | Current NDC, Legacy NDC, 2 package rows | 20250228_7e117c7e-02fc-4343-92a1-230061dfc5e0.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 50458-355-28 | 50458035528 | 7 in 1 BOX | Historical |