DrugDashboards

Tolvaptan

Tolvaptan · TOLVAPTAN 30 mg/1 · Tablet · Teva Pharmaceuticals, Inc.

NDC 00480-5481-77 · 38462 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

All Part D pricing →

Matched to CMS's representative package for this drug (NDC 59148-0021-50) — same generic, strength, and dosage form. CMS prices one NDC per drug concept, not every package.

ⓘ How this was built
Data sources
  • CMS quarterly Prescription Drug Plan Formulary & Pricing files (SPUF)
Method

Negotiated 30-day point-of-sale unit prices and formulary terms aggregated across every unsuppressed Part D and MA-PD plan for the quarter shown. Point of sale means gross of confidential rebates. CMS publishes one representative NDC per drug concept (RxCUI) rather than every package, so these figures come from CMS's representative package for the same drug — matched on generic name, strength, and dosage form. Estimated from MedPAC's program-wide rebate aggregates (June 2023: DIR = 29% of gross Part D spending; brand rebates ≈ 25–40% of gross, generics minimal). Actual rebates are confidential and vary widely by drug — this is a range, not a fact about this drug.

Pipeline and calculations built by Claude (Fable 5) from the public datasets above. Educational only — verify against primary sources before acting.

Plans pay at point of saleⓘ
$531.13per unit
middle half $531.13–$531.13 · 2 plans · Apr 1, 2026
Est. net of rebatesⓘ
≈ $531.13
generic — rebates are minimal, so net ≈ gross
Coverage & restrictions
0%of plans cover it
tier 1 · prior auth 100% · step therapy 0% · qty limit 0%

*No drug-level rebate is public — the estimate applies MedPAC's program-wide brand rebate range to this drug's gross price. Tracked here for 10 quarters since 2024.

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)

0.0%chance of a new FDA shortage posting for tolvaptan (oral solid) in the next 90 days

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)

LabelerStrengthFirst seenLast seen
Ascend Laboratories, LLCTOLVAPTAN 60 mg/1Jul 15, 2026Sep 3, 2026
Ascend Laboratories, LLCTOLVAPTAN 15 mg/1Jul 15, 2026Sep 3, 2026
Ascend Laboratories, LLCTOLVAPTAN 30 mg/1Jul 15, 2026Sep 3, 2026
Teva Pharmaceuticals, Inc.TOLVAPTAN 60 mg/1Jul 23, 2026Sep 3, 2026
Teva Pharmaceuticals, Inc.TOLVAPTAN 45 mg/1Jul 23, 2026Sep 3, 2026
Teva Pharmaceuticals, Inc.TOLVAPTAN 15 mg/1Jul 23, 2026Sep 3, 2026
Teva Pharmaceuticals, Inc.TOLVAPTAN 30 mg/1Jul 23, 2026Sep 3, 2026
Teva Pharmaceuticals, Inc.TOLVAPTAN 90 mg/1Jul 23, 2026Sep 3, 2026
Apotex Corp.TOLVAPTAN 30 mg/1Jul 15, 2026Sep 2, 2026
Apotex Corp.TOLVAPTAN 15 mg/1Jul 15, 2026Sep 2, 2026
Ascend Laboratories, LLCTOLVAPTAN 90 mg/1Aug 26, 2026Sep 2, 2026
Ascend Laboratories, LLCTOLVAPTAN 45 mg/1Aug 26, 2026Sep 2, 2026
Camber Pharmaceuticals, Inc.TOLVAPTAN 15 mg/1Jul 15, 2026Sep 2, 2026
Camber Pharmaceuticals, Inc.TOLVAPTAN 30 mg/1Jul 15, 2026Sep 2, 2026
Lupin Pharmaceuticals, Inc.TOLVAPTAN 15 mg/1Jul 15, 2026Sep 2, 2026
Lupin Pharmaceuticals, Inc.TOLVAPTAN 30 mg/1Jul 15, 2026Sep 2, 2026
Northstar Rx LLCTOLVAPTAN 15 mg/1Jul 15, 2026Sep 2, 2026
Northstar Rx LLCTOLVAPTAN 30 mg/1Jul 15, 2026Sep 2, 2026
Novadoz Pharmaceuticals LLCTOLVAPTAN 30 mg/1Jul 15, 2026Sep 2, 2026
Novadoz Pharmaceuticals LLCTOLVAPTAN 15 mg/1Jul 15, 2026Sep 2, 2026
Otsuka America Pharmaceutical, Inc.TOLVAPTAN 15 mg/1Jul 15, 2026Sep 2, 2026
Otsuka Pharmaceutical Co., Ltd.TOLVAPTAN 90 mg/1Jul 15, 2026Sep 2, 2026
Otsuka Pharmaceutical Co., Ltd.TOLVAPTAN 15 mg/1Jul 15, 2026Sep 2, 2026
Otsuka Pharmaceutical Co., Ltd.TOLVAPTAN 30 mg/1Jul 15, 2026Sep 2, 2026
Otsuka Pharmaceutical Co., Ltd.TOLVAPTAN 45 mg/1Jul 15, 2026Sep 2, 2026
Otsuka Pharmaceutical Co., Ltd.TOLVAPTAN 60 mg/1Jul 15, 2026Sep 2, 2026
Par Health USA, LLCTOLVAPTAN 15 mg/1Aug 26, 2026Sep 2, 2026
Par Health USA, LLCTOLVAPTAN 30 mg/1Aug 26, 2026Sep 2, 2026
Otsuka America Pharmaceutical, Inc.TOLVAPTAN 30 mg/1Jul 15, 2026Aug 31, 2026
Endo USA, Inc.TOLVAPTAN 15 mg/1Jul 15, 2026Aug 19, 2026
Endo USA, Inc.TOLVAPTAN 30 mg/1Jul 15, 2026Aug 19, 2026

Roster from daily NDC Directory diffs — first/last seen dates start July 2026.

Cite this page

DrugDashboards, "Tolvaptan — NDC 00480-5481-77," retrieved September 3, 2026, https://drugdashboards.com/drug/00480548177.

Free to cite with attribution — see how the data is put together.