NDC 69468-151

VISTOGARD

Uridine Triacetate

VISTOGARD is a Oral Granule in the Human Prescription Drug category. It is labeled and distributed by Wellstat Therapeutics Corporation. The primary component is Uridine Triacetate.

• Product ID: 69468-151_8e64b577-1ecb-46f2-a7c8-3577a16f8837
• NDC: 69468-151
• Product Type: Human Prescription Drug
• Proprietary Name: VISTOGARD
• Generic Name: Uridine Triacetate
• Dosage Form: Granule
• Route of Administration: ORAL
• Marketing Start Date: 2016-03-01
• Marketing Category: NDA / NDA
• Application Number: NDA208159
• Labeler Name: Wellstat Therapeutics Corporation
• Substance Name: URIDINE TRIACETATE
• Active Ingredient Strength: 951 mg/g
• Pharm Classes: Pyrimidine Analog [EPC],Pyrimidines [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 69468-151-04

4 PACKET in 1 CARTON (69468-151-04) > 10 g in 1 PACKET (69468-151-10)

• Marketing Start Date: 2016-03-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 69468-151-04 [69468015104]

VISTOGARD GRANULE

• Marketing Category: NDA
• Application Number: NDA208159
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2016-03-01

NDC 69468-151-10 [69468015110]

VISTOGARD GRANULE

• Marketing Category: NDA
• Application Number: NDA208159
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2016-03-01

NDC 69468-151-20 [69468015120]

VISTOGARD GRANULE

• Marketing Category: NDA
• Application Number: NDA208159
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2016-03-01

Drug Details

Active Ingredients

Ingredient	Strength
URIDINE TRIACETATE	951 mg/g

OpenFDA Data

• SPL SET ID: 5a0ba417-8a4a-4d7f-b85a-1839ee8bd3f1
• Manufacturer:
  • Wellstat Therapeutics Corporation
• UNII:
  • 2WP61F175M
• RxNorm Concept Unique ID - RxCUI:
  • 1739800
  • 1739794

Pharmacological Class

• Pyrimidine Analog [EPC]
• Pyrimidines [Chemical/Ingredient]
• Analogs/Derivatives [Chemical/Ingredient]
• Pyrimidine Analog [EPC]
• Pyrimidines [Chemical/Ingredient]
• Analogs/Derivatives [Chemical/Ingredient]

NDC Crossover Matching brand name "VISTOGARD" or generic name "Uridine Triacetate"

NDC	Brand Name	Generic Name
69468-151	VISTOGARD	uridine triacetate
69468-152	XURIDEN	uridine triacetate