SAMSCA
- Product NDC
- 59148-021
- 11-digit product format
- 591480021
- Labeler code
- 59148
- Product ID
- 59148-021_701668e3-9542-46eb-b6c9-f7553d33385d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- tolvaptan
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Otsuka America Pharmaceutical, Inc.
- Application
- NDA022275
- Marketing category
- NDA
- Marketing start
- 2009-05-19
- Substance
- TOLVAPTAN
- Active strength
- 30 mg/1
- Pharmacologic classes
- Vasopressin V2 Receptor Antagonist [EPC], Vasopressin V2 Receptor Antagonists [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- SAMSCA
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| TOLVAPTAN | 30 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 21G72T1950 |
| Rxcui | 849827, 849831, 849833, 849835 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 59148-021-50 | SAMSCA | 10 in 1 BLISTER PACK | TABLET | 10 | | 22 |
| 59148-021-50 | SAMSCA | 1 in 1 CARTON | TABLET | 1 | | 22 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 59148-021 | SAMSCA (TOLVAPTAN) TABLET [OTSUKA AMERICA PHARMACEUTICAL, INC.] | 21 | Current NDC, Legacy NDC, 2 package rows | 20221119_5526617c-c7b9-4556-886d-729bbabbc566.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 |
|---|
| 59148-021-50 | 59148002150 | 1 BLISTER PACK in 1 CARTON (59148-021-50) / 10 TABLET in 1 BLISTER PACK | 1 blister pack | 2009-05-19 | 0000-00-00 | No | No | Current |