Tolvaptan
- Product NDC
- 67877-636
- 11-digit product format
- 678770636
- Labeler code
- 67877
- Product ID
- 67877-636_f75355a8-50ef-4a88-aaa0-c85c0ae5c23d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Tolvaptan
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Ascend Laboratories, LLC
- Application
- ANDA211891
- Marketing category
- ANDA
- Marketing start
- 2020-05-21
- 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
- Tolvaptan
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| TOLVAPTAN | 30 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 21G72T1950 |
| Rxcui | 849827, 849833, 2044363 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 67877-636-01 | Tolvaptan | 100 in 1 BOTTLE | TABLET | 100 | | 10 |
| 67877-636-02 | Tolvaptan | 10 in 1 BOTTLE | TABLET | 10 | | 10 |
| 67877-636-33 | Tolvaptan | 1 in 1 CARTON | TABLET | 1 | | 10 |
| 67877-636-33 | Tolvaptan | 10 in 1 BLISTER PACK | TABLET | 10 | | 10 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 67877-636 | TOLVAPTAN TABLET [ASCEND LABORATORIES, LLC] | 10 | Current NDC, Legacy NDC, 4 package rows | 20220909_dd71ee70-9435-4715-bee5-edbb5a8d7d7b.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 |
|---|
| 67877-636-01 | 67877063601 | 100 TABLET in 1 BOTTLE (67877-636-01) | 100 tablet | 2020-05-21 | 0000-00-00 | No | No | Current |
| 67877-636-02 | 67877063602 | 10 TABLET in 1 BOTTLE (67877-636-02) | 10 tablet | 2020-05-21 | 0000-00-00 | No | No | Current |
| 67877-636-33 | 67877063633 | 1 BLISTER PACK in 1 CARTON (67877-636-33) / 10 TABLET in 1 BLISTER PACK | 1 blister pack | 2020-05-21 | 0000-00-00 | No | No | Current |