NDC 69468-152

XURIDEN

Uridine Triacetate

XURIDEN 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: 69468-152_295791f6-d738-4498-9033-e749be179c88
• NDC: 69468-152
• Product Type: Human Prescription Drug
• Proprietary Name: XURIDEN
• Generic Name: Uridine Triacetate
• Dosage Form: Granule
• Route of Administration: ORAL
• Marketing Start Date: 2015-09-08
• Marketing Category: NDA / NDA
• Application Number: NDA208169
• 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 69468-152-02

2 g in 1 PACKET (69468-152-02)

• Marketing Start Date: 2015-09-08
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 69468-152-30 [69468015230]

XURIDEN GRANULE

• Marketing Category: NDA
• Application Number: NDA208169
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2015-09-08

NDC 69468-152-02 [69468015202]

XURIDEN GRANULE

• Marketing Category: NDA
• Application Number: NDA208169
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2015-09-08

Drug Details

Active Ingredients

Ingredient	Strength
URIDINE TRIACETATE	951 mg/g

OpenFDA Data

• SPL SET ID: 40606ca9-4f14-45b7-8632-fc2d17d11a2e
• Manufacturer:
  • Wellstat Therapeutics Corporation
• UNII:
  • 2WP61F175M
• RxNorm Concept Unique ID - RxCUI:
  • 1665473
  • 1665467

Pharmacological Class

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

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

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