TOLVAPTAN
- Product NDC
- 72603-933
- 11-digit product format
- 726030933
- Labeler code
- 72603
- Product ID
- 72603-933_3dd69146-6f15-4c54-a6d9-7408e6c41548
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- TOLVAPTAN
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Northstar Rx LLC
- Application
- ANDA216949
- Marketing category
- ANDA
- Marketing start
- 2023-06-21
- 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
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- TOLVAPTAN
- 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, 849833 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 72603-933-01 | TOLVAPTAN | 10 in 1 BLISTER PACK | TABLET | 10 | | 3 |
| 72603-933-01 | TOLVAPTAN | 1 in 1 CARTON | TABLET | 1 | | 3 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 72603-933-01 | 72603093301 | 10 in 1 BLISTER PACK | Historical |