NDC 59148-020

SAMSCA

Tolvaptan

SAMSCA is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Otsuka America Pharmaceutical, Inc.. The primary component is Tolvaptan.

• Product ID: 59148-020_17d25d59-6f09-4e2e-9c87-382d4f780e4f
• NDC: 59148-020
• Product Type: Human Prescription Drug
• Proprietary Name: SAMSCA
• Generic Name: Tolvaptan
• Dosage Form: Tablet
• Route of Administration: ORAL
• Marketing Start Date: 2009-05-19
• Marketing Category: NDA / NDA
• Application Number: NDA022275
• Labeler Name: Otsuka America Pharmaceutical, Inc.
• Substance Name: TOLVAPTAN
• Active Ingredient Strength: 15 mg/1
• Pharm Classes: Vasopressin V2 Receptor Antagonist [EPC], Vasopressin V2 Receptor Antagonists [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2023-12-31

Packaging

NDC 59148-020-50

1 BLISTER PACK in 1 CARTON (59148-020-50) > 10 TABLET in 1 BLISTER PACK

• Marketing Start Date: 2009-05-19
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 59148-020-50 [59148002050]

SAMSCA TABLET

• Marketing Category: NDA
• Application Number: NDA022275
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2009-05-19

Drug Details

Active Ingredients

Ingredient	Strength
TOLVAPTAN	15 mg/1

OpenFDA Data

• SPL SET ID: 5526617c-c7b9-4556-886d-729bbabbc566
• Manufacturer:
  • Otsuka America Pharmaceutical, Inc.
• UNII:
  • 21G72T1950
• RxNorm Concept Unique ID - RxCUI:
  • 849835
  • 849827
  • 849831
  • 849833

Pharmacological Class

• Vasopressin V2 Receptor Antagonist [EPC]
• Vasopressin V2 Receptor Antagonists [MoA]

Medicade Reported Pricing

59148002050 SAMSCA 15 MG TABLET

Pricing Unit: EA | Drug Type:

NDC Crossover Matching brand name "SAMSCA" or generic name "Tolvaptan"

NDC	Brand Name	Generic Name
59148-020	SAMSCA	tolvaptan
59148-021	SAMSCA	tolvaptan
59148-079	Jynarque	tolvaptan
59148-080	Jynarque	tolvaptan
59148-082	JYNARQUE	tolvaptan
59148-083	JYNARQUE	tolvaptan
59148-087	Jynarque	tolvaptan
59148-088	Jynarque	tolvaptan
31722-868	Tolvaptan	Tolvaptan
31722-869	Tolvaptan	Tolvaptan
49884-768	Tolvaptan	Tolvaptan
49884-770	Tolvaptan	Tolvaptan