Quick answers
- What is Tolvaptan used for?
- The FDA-approved label (Samsca, Otsuka America Pharmaceutical, Inc., May 7, 2026) says: “SAMSCA ® is indicated for the treatment of clinically significant hypervolemic and euvolemic hyponatremia (serum sodium <125 mEq/L or less marked hyponatremia that is symptomatic and has resisted correction with fluid restriction), including patients with heart failure and Syndrome of Inappropriate Antidiuretic Hormone (SIADH). …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Tolvaptan have a boxed warning?
- Yes. The FDA label for Samsca has a boxed warning, the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
- Is there a shortage of Tolvaptan?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Tolvaptan been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Tolvaptan?
- 8 companies list prescription products of Tolvaptan in the FDA NDC Directory, including Ascend Laboratories, LLC, Otsuka America Pharmaceutical, Inc. and Apotex Corp..
What Tolvaptan is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
SAMSCA ® is indicated for the treatment of clinically significant hypervolemic and euvolemic hyponatremia (serum sodium <125 mEq/L or less marked hyponatremia that is symptomatic and has resisted correction with fluid restriction), including patients with heart failure and Syndrome of Inappropriate Antidiuretic Hormone (SIADH). …
— FDA label: Samsca, Otsuka America Pharmaceutical, Inc., effective May 7, 2026. Read the full label on DailyMed →
The FDA has 8 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Conditions named on the label
These condition names appear word for word in the label’s “Indications and Usage” text (matched with a reviewed table). Each page lists hospitals whose own websites name the condition.
Related medical specialties
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
This label has a boxed warning. Read it on the full label →
8 of 8 FDA labels for this medicine have a boxed warning.
Forms and how it is given
What pharmacies pay (NADAC)
The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.
This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.
| Strength and form | Generic or brand | Pharmacies pay |
|---|---|---|
| tolvaptan 15 mg tablet | Generic | $11.78 per tablet |
NADAC list of November 4, 2026; these prices took effect on October 21, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.
Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Ascend Laboratories, LLC8 products
- Otsuka America Pharmaceutical, Inc.4 products
- Apotex Corp.4 products
- Par Health USA, LLC2 products
- Novadoz Pharmaceuticals LLC2 products
- Lupin Pharmaceuticals, Inc.2 products
- NorthStar Rx LLC2 products
- Camber Pharmaceuticals, Inc.2 products
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA022275 SAMSCA | Otsuka | May 19, 2009 | 11, latest April 22, 2021 2021: Labeling · 2018: Labeling · 2017: Labeling |
| NDA204441 JYNARQUE | Otsuka | April 23, 2018 | 9, latest September 15, 2026 2026: Labeling · 2025: REMS · 2024: Manufacturing (CMC) |
Generic approvals (8)
- ANDA207605Apotex · May 19, 2020
- ANDA211891Alkem Labs Ltd · May 19, 2020
- ANDA205646Hetero Labs Ltd V · July 16, 2021
- ANDA206119Ph Health · February 15, 2022
- ANDA216949Msn · June 21, 2023
- ANDA216063Lupin · April 23, 2025
- ANDA218381Apotex · November 10, 2025
- ANDA220147Alkem Labs Ltd · April 21, 2026
Shortage status
The FDA drug shortage list does not show these products.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Samsca, Otsuka America Pharmaceutical, Inc., effective May 7, 2026; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →