FDA.reportPublic FDA data

VISTOGARD

Product NDC
50633-220
11-digit product format
506330220
Labeler code
50633
Product ID
50633-220_4e4e69bd-abb4-4632-e063-6394a90ab642
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
uridine triacetate
Dosage form
GRANULE
Route
ORAL
Labeler
BTG International Inc
Application
NDA208159
Marketing category
NDA
Marketing start
2024-07-31
Substance
URIDINE TRIACETATE
Active strength
951 mg/g
Pharmacologic classes
Analogs/Derivatives [Chemical/Ingredient], Pyrimidine Analog [EPC], Pyrimidines [Chemical/Ingredient]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
VISTOGARD
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
URIDINE TRIACETATE951 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii2WP61F175M
Rxcui1739794, 1739800

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
aef517b6-a1af-4b03-aa34-2de7d01970b0Product name120151218
befe3fd1-a84f-4723-b9ec-997073cb5483Product name120151105

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50633-220-04VISTOGARD4 in 1 CARTONGRANULE43
50633-220-10VISTOGARD10 g in 1 PACKETGRANULE103
50633-220-20VISTOGARD20 in 1 CARTONGRANULE203

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50633-220-04EA - Each50633-220c27858f1-4531-455b-9c0a-3bb4f432010b12024-09-09
50633-220-20EA - Each50633-220b8cadbd1-edab-4ed5-92b3-3a1dbfefb32f12024-09-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50633-220VISTOGARD (URIDINE TRIACETATE) GRANULE [BTG INTERNATIONAL INC]2Current NDC, 3 package rows20250210_269f7363-63ed-444e-85f1-f0009e44818b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1739794uridine triacetate 10 GM Oral GranulesPSN269f7363-63ed-444e-85f1-f0009e44818b3
1739800VISTOGARD 10 GM Oral GranulesPSN269f7363-63ed-444e-85f1-f0009e44818b3
1739800uridine triacetate 10000 MG Oral Granules [Vistogard]SBD269f7363-63ed-444e-85f1-f0009e44818b3
1739794uridine triacetate 10000 MG Oral GranulesSCD269f7363-63ed-444e-85f1-f0009e44818b3
1739800Vistogard 10 GM Oral GranulesSY269f7363-63ed-444e-85f1-f0009e44818b3
1739800Vistogard 10,000 MG Oral GranulesSY269f7363-63ed-444e-85f1-f0009e44818b3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50633-220-04506330220044 PACKET in 1 CARTON (50633-220-04) / 10 g in 1 PACKET (50633-220-10) 4 packet2024-07-31NoNoCurrent
50633-220-105063302201010 g in 1 PACKET10 gHistorical
50633-220-205063302202020 PACKET in 1 CARTON (50633-220-20) / 10 g in 1 PACKET (50633-220-10) 20 packet2024-07-31NoNoCurrent