Tolvaptan
Tolvaptan · TOLVAPTAN 45 mg/1 · Tablet · Teva Pharmaceuticals, Inc.
NDC 00480-5482-77 · 25641 TABLET in 1 BOTTLE · DRUG FOR FURTHER PROCESSING · View full market →
Bulk ingredient — not a finished product
This NDC is a raw material (drug for further processing) sold to drug manufacturers or compounders, not a product pharmacies dispense. Retail pricing, TE codes, fragility scores, and shortage reports don't apply to bulk listings — those attach to finished products made from this ingredient.
Medicare Part D
This is a bulk ingredient, not a dispensable product — it is a raw material sold to manufacturers and compounders, so no plan prices it.
How Part D pricing works →NADAC price per unit
No NADAC pricing on file for this NDC — NADAC covers drugs dispensed by retail community pharmacies.
Supply fragility
Not scored — fragility is computed for NADAC-priced NDCs.
90-day shortage risk (model v2)
sole-source market
For scale: the typical drug’s chance is about 0.1% — this one is in ordinary territory.
Backtested statistical model over the whole market, not this package alone. Model details →
Is this a "specialty" drug?
There's no legal definition — it meets 2 of 6 public criteria. Why that matters →
- Part D specialty tier
- Costs ≥ $950/fill · avg $10,653.82 per prescription
- Biologic (BLA)
- Injectable / infused
- Orphan-drug exclusivity
- REMS program · Tolvaptan for ADPKD Shared System REMS Shared System REMS
Regulatory
- Application
- —
- TE code
- —
- Approval date
- —
- Patents / exclusivity
- —
Shortage history
No FDA shortage reports for this drug or its presentations.
Recalls (this NDC)
No enforcement reports list this package NDC.
Manufacturers of Tolvaptan (Tablet)
| Labeler | Strength | First seen | Last seen |
|---|---|---|---|
| Ascend Laboratories, LLC | TOLVAPTAN 60 mg/1 | Jul 15, 2026 | Sep 3, 2026 |
| Ascend Laboratories, LLC | TOLVAPTAN 15 mg/1 | Jul 15, 2026 | Sep 3, 2026 |
| Ascend Laboratories, LLC | TOLVAPTAN 30 mg/1 | Jul 15, 2026 | Sep 3, 2026 |
| Teva Pharmaceuticals, Inc. | TOLVAPTAN 60 mg/1 | Jul 23, 2026 | Sep 3, 2026 |
| Teva Pharmaceuticals, Inc. | TOLVAPTAN 45 mg/1 | Jul 23, 2026 | Sep 3, 2026 |
| Teva Pharmaceuticals, Inc. | TOLVAPTAN 15 mg/1 | Jul 23, 2026 | Sep 3, 2026 |
| Teva Pharmaceuticals, Inc. | TOLVAPTAN 30 mg/1 | Jul 23, 2026 | Sep 3, 2026 |
| Teva Pharmaceuticals, Inc. | TOLVAPTAN 90 mg/1 | Jul 23, 2026 | Sep 3, 2026 |
| Apotex Corp. | TOLVAPTAN 30 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Apotex Corp. | TOLVAPTAN 15 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Ascend Laboratories, LLC | TOLVAPTAN 90 mg/1 | Aug 26, 2026 | Sep 2, 2026 |
| Ascend Laboratories, LLC | TOLVAPTAN 45 mg/1 | Aug 26, 2026 | Sep 2, 2026 |
| Camber Pharmaceuticals, Inc. | TOLVAPTAN 15 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Camber Pharmaceuticals, Inc. | TOLVAPTAN 30 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Lupin Pharmaceuticals, Inc. | TOLVAPTAN 15 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Lupin Pharmaceuticals, Inc. | TOLVAPTAN 30 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Northstar Rx LLC | TOLVAPTAN 15 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Northstar Rx LLC | TOLVAPTAN 30 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Novadoz Pharmaceuticals LLC | TOLVAPTAN 30 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Novadoz Pharmaceuticals LLC | TOLVAPTAN 15 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Otsuka America Pharmaceutical, Inc. | TOLVAPTAN 15 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Otsuka Pharmaceutical Co., Ltd. | TOLVAPTAN 90 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Otsuka Pharmaceutical Co., Ltd. | TOLVAPTAN 15 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Otsuka Pharmaceutical Co., Ltd. | TOLVAPTAN 30 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Otsuka Pharmaceutical Co., Ltd. | TOLVAPTAN 45 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Otsuka Pharmaceutical Co., Ltd. | TOLVAPTAN 60 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Par Health USA, LLC | TOLVAPTAN 15 mg/1 | Aug 26, 2026 | Sep 2, 2026 |
| Par Health USA, LLC | TOLVAPTAN 30 mg/1 | Aug 26, 2026 | Sep 2, 2026 |
| Otsuka America Pharmaceutical, Inc. | TOLVAPTAN 30 mg/1 | Jul 15, 2026 | Aug 31, 2026 |
| Endo USA, Inc. | TOLVAPTAN 15 mg/1 | Jul 15, 2026 | Aug 19, 2026 |
| Endo USA, Inc. | TOLVAPTAN 30 mg/1 | Jul 15, 2026 | Aug 19, 2026 |
Roster from daily NDC Directory diffs — first/last seen dates start July 2026.
Cite this page
DrugDashboards, "Tolvaptan — NDC 00480-5482-77," retrieved September 3, 2026, https://drugdashboards.com/drug/00480548277.
Free to cite with attribution — see how the data is put together.