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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N208159-001VISTOGARDURIDINE TRIACETATE10GM/PACKETGRANULE / ORALRLD, RS2015-12-11

Orange Book patents#

Current patent rows page 1 of 1 · 1 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N208159-00177768382027-08-17U-17912015-12-16

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06N208159-001VISTOGARD10GM/PACKETGRANULE / ORALRLD, RS2015-12-11a50c72e98297…

Observed Orange Book patent history#

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-08-01 22:54:322026-06N208159-00177768382027-08-17U-17912015-12-16a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
VISTOGARDURIDINE TRIACETATEBTG International Inc269f7363-63ed-444e-85f1-f0009e44818b2026-03-31Warnings, Adverse reactionsExact identifier
application applno (NDA): 208159
application number: NDA208159
ndc (product): 50633-220

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 UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2WP61F175MInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1739794Internal RxNorm lookup
1739800Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
269f7363-63ed-444e-85f1-f0009e44818bAvailable on FDA.report

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