NDC 59148-089

Jynarque

Tolvaptan

Jynarque is a Kit in the Human Prescription Drug category. It is labeled and distributed by Otsuka America Pharmaceutical, Inc.. The primary component is .

• Product ID: 59148-089_1c7d17da-0b48-425b-949a-6f90bfd3a71c
• NDC: 59148-089
• Product Type: Human Prescription Drug
• Proprietary Name: Jynarque
• Generic Name: Tolvaptan
• Dosage Form: Kit
• Marketing Start Date: 2018-04-23
• Marketing Category: NDA / NDA
• Application Number: NDA204441
• Labeler Name: Otsuka America Pharmaceutical, Inc.
• Active Ingredient Strength: 0
• NDC Exclude Flag: N
• Listing Certified Through: 2022-12-31

Packaging

NDC 59148-089-28

4 BLISTER PACK in 1 CARTON (59148-089-28) > 1 KIT in 1 BLISTER PACK (59148-089-07)

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

NDC SPL Data Element Entries

NDC 59148-089-28 [59148008928]

Jynarque KIT

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

NDC 59148-089-07 [59148008907]

Jynarque KIT

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

Drug Details

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

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