Tolvaptan
- Product NDC
- 67877-635
- 11-digit product format
- 678770635
- Labeler code
- 67877
- Product ID
- 67877-635_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
- 2022-09-07
- Substance
- TOLVAPTAN
- Active strength
- 15 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
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| 21G72T1950 | TOLVAPTAN | 150683-30-0 | TOLVAPTAN |
Packages
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 67877-635-01 | 67877063501 | 100 TABLET in 1 BOTTLE (67877-635-01) | 100 tablet | 2022-09-07 | No | No | Historical |
| 67877-635-02 | 67877063502 | 10 TABLET in 1 BOTTLE (67877-635-02) | 10 tablet | 2022-09-07 | No | No | Historical |
| 67877-635-33 | 67877063533 | 1 BLISTER PACK in 1 CARTON (67877-635-33) / 10 TABLET in 1 BLISTER PACK | 1 blister pack | 2022-09-07 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Tolvaptan | Ascend Laboratories, LLC | Alkem Laboratories Limited | 2022-09-07 | Human Prescription Drug Label | 10 |