NDC 59148-083

JYNARQUE

Tolvaptan

JYNARQUE 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: 59148-083_1c7d17da-0b48-425b-949a-6f90bfd3a71c
• NDC: 59148-083
• Product Type: Human Prescription Drug
• Proprietary Name: JYNARQUE
• Generic Name: Tolvaptan
• Dosage Form: Tablet
• Route of Administration: ORAL
• Marketing Start Date: 2018-04-23
• Marketing Category: NDA / NDA
• Application Number: NDA204441
• Labeler Name: Otsuka America Pharmaceutical, Inc.
• Substance Name: TOLVAPTAN
• Active Ingredient Strength: 30 mg/1
• Pharm Classes: Vasopressin V2 Receptor Antagonist [EPC],Vasopressin V2 Receptor Antagonists [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2022-12-31

Packaging

NDC 59148-083-13

1 BOTTLE in 1 CARTON (59148-083-13) > 30 TABLET in 1 BOTTLE

• Marketing Start Date: 2018-04-23
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 59148-083-13 [59148008313]

JYNARQUE TABLET

• Marketing Category: NDA
• Application Number: NDA204441
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2018-04-23

Drug Details

Active Ingredients

Ingredient	Strength
TOLVAPTAN	30 mg/1

OpenFDA Data

• SPL SET ID: 3febc0a1-9e5a-4ce0-843d-210f21d862c4
• Manufacturer:
  • Otsuka America Pharmaceutical, Inc.
• UNII:
  • 21G72T1950
• RxNorm Concept Unique ID - RxCUI:
  • 2044369
  • 849827
  • 2044361
  • 2044363
  • 2044365
  • 2044367
  • 2044355
  • 2044357
  • 2044966
  • 2044967
  • 2044971
  • 2044968
  • 2044969
  • 2044359
  • 2044970
  • 849833
• UPC Code:
  • 0359148083131

Pharmacological Class

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

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

NDC	Brand Name	Generic Name
59148-079	Jynarque	tolvaptan
59148-080	Jynarque	tolvaptan
59148-082	JYNARQUE	tolvaptan
59148-083	JYNARQUE	tolvaptan
59148-087	Jynarque	tolvaptan
59148-088	Jynarque	tolvaptan
59148-089	Jynarque	Jynarque
59148-020	SAMSCA	tolvaptan
59148-021	SAMSCA	tolvaptan
31722-868	Tolvaptan	Tolvaptan
31722-869	Tolvaptan	Tolvaptan
49884-768	Tolvaptan	Tolvaptan
49884-770	Tolvaptan	Tolvaptan