tolvaptan
- Product NDC
- 60505-4318
- 11-digit product format
- 605054318
- Labeler code
- 60505
- Product ID
- 60505-4318_690cc374-8439-3e20-77d1-acade3cad332
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- tolvaptan
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Apotex Corp.
- Application
- ANDA207605
- Marketing category
- ANDA
- Marketing start
- 2022-07-05
- 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
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 |
|---|
| 60505-4318-0 | 60505431800 | 1 BLISTER PACK in 1 CARTON (60505-4318-0) / 10 TABLET in 1 BLISTER PACK | 1 blister pack | 2022-07-05 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| tolvaptan | Apotex Corp. | Apotex Inc. | 2025-09-22 | HUMAN PRESCRIPTION DRUG LABEL | 8 |