TOLVAPTAN
- Product NDC
- 72205-131
- 11-digit product format
- 722050131
- Labeler code
- 72205
- Product ID
- 72205-131_92ce12f1-eae0-4c83-9a4e-a5181e08fa92
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- TOLVAPTAN
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Novadoz Pharmaceuticals 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
- 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 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 72205-131-11 | TOLVAPTAN | 1 in 1 CARTON | TABLET | 1 | | 1 |
| 72205-131-11 | TOLVAPTAN | 10 in 1 BLISTER PACK | TABLET | 10 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 72205-131 | TOLVAPTAN TABLET [NOVADOZ PHARMACEUTICALS LLC] | 1 | Current NDC, 2 package rows | 20231004_92ce12f1-eae0-4c83-9a4e-a5181e08fa92.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 72205-131-11 | 72205013111 | 1 BLISTER PACK in 1 CARTON (72205-131-11) / 10 TABLET in 1 BLISTER PACK | 1 blister pack | 2023-09-26 | No | No | Current |