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Tolvaptan

Generic Name
Tolvaptan
Brand Names
Jinarc, Jynarque 45/15 Carton, Samsca, Tolvaptan Accord, Xeljanz
Drug Type
Small Molecule
Chemical Formula
C26H25ClN2O3
CAS Number
150683-30-0
Unique Ingredient Identifier
1E2497LPNY

Overview

Tolvaptan is used to treat low blood sodium levels (hyponatremia) associated with various conditions like congestive heart failure, cirrhosis, and syndrome of inappropriate antidiuretic hormones (SIADH). FDA approved on May 19, 2009.

Background

Tolvaptan is used to treat low blood sodium levels (hyponatremia) associated with various conditions like congestive heart failure, cirrhosis, and syndrome of inappropriate antidiuretic hormones (SIADH). FDA approved on May 19, 2009.

Indication

Treatment of symptomatic and resistant to fluid restriction euvolemic or hypervolemic hyponatremia associated with congestive heart failure, SIADH, and cirrhosis.

Associated Conditions

  • Autosomal Dominant Polycystic Kidney Disease (ADPKD)
  • Symptomatic euvolemic Hyponatremia
  • Symptomatic hypervolemic Hyponatremia

FDA Approved Products

Tolvaptan
Manufacturer:Ascend Laboratories, LLC
Route:ORAL
Strength:15 mg in 1 1
Approved: 2022/09/07
NDC:67877-635
TOLVAPTAN
Manufacturer:Novadoz Pharmaceuticals LLC
Route:ORAL
Strength:15 mg in 1 1
Approved: 2023/03/31
NDC:72205-130
JYNARQUE
Manufacturer:Otsuka America Pharmaceutical, Inc.
Route:ORAL
Strength:30 mg in 1 1
Approved: 2020/10/23
NDC:59148-083
Tolvaptan
Manufacturer:Par Pharmaceutical, Inc.
Route:ORAL
Strength:30 mg in 1 1
Approved: 2022/03/10
NDC:49884-770
XELJANZ
Manufacturer:Pfizer Laboratories Div Pfizer Inc
Route:ORAL
Strength:1 mg in 1 mL
Approved: 2023/05/23
NDC:0069-1029

Singapore Approved Products

JINARC TABLET 15MG
Manufacturer:Otsuka Pharmaceutical Co., Ltd. - Tokushima Factory (DP intermediate), Otsuka Pharmaceutical Co., Ltd. - Tokushima Itano Factory, PT Otsuka Indonesia (Primary packager and Secondary packager)
Form:TABLET
Strength:15mg
Online:Yes
Approved: 2022/09/23
Approval:SIN16607P
SAMSCA TABLET 15MG
Manufacturer:Korea Otsuka Pharmaceutical Co., Ltd., Otsuka Pharmaceutical Co., Ltd. - Tokushima Factory (DP intermediate)
Form:TABLET
Strength:15mg
Online:Yes
Approved: 2020/04/24
Approval:SIN15934P
JINARC TABLET 45MG/15MG
Manufacturer:Otsuka Pharmaceutical Co., Ltd. - Tokushima Factory (DP intermediate), Otsuka Pharmaceutical Co., Ltd. - Tokushima Itano Factory, AndersonBrecon (UK) Ltd. (Primary and Secondary Packager)
Form:TABLET
Strength:15.000mg
Online:Yes
Approved: 2022/09/23
Approval:SIN16609P
JINARC TABLET 60MG/30MG
Manufacturer:Otsuka Pharmaceutical Co., Ltd. - Tokushima Factory (DP intermediate), Otsuka Pharmaceutical Co., Ltd. - Tokushima Itano Factory, AndersonBrecon (UK) Ltd. (Primary and Secondary Packager)
Form:TABLET
Strength:60.000mg
Online:Yes
Approved: 2022/09/23
Approval:SIN16610P
JINARC TABLET 90MG/30MG
Manufacturer:Otsuka Pharmaceutical Co., Ltd. - Tokushima Factory (DP intermediate), Otsuka Pharmaceutical Co., Ltd. - Tokushima Itano Factory, AndersonBrecon (UK) Ltd. (Primary and Secondary Packager)
Form:TABLET
Strength:30.000mg
Online:Yes
Approved: 2022/09/23
Approval:SIN16611P

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