FDA.reportPublic FDA data

XURIDEN

Product NDC
50633-330
11-digit product format
506330330
Labeler code
50633
Product ID
50633-330_2e671cf8-09be-ac40-e063-6294a90aaf8f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
uridine triacetate
Dosage form
GRANULE
Route
ORAL
Labeler
BTG International Inc
Application
NDA208169
Marketing category
NDA
Marketing start
2024-05-31
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
XURIDEN
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
URIDINE TRIACETATE951 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii2WP61F175M
Rxcui1665467, 1665473

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
50633-330-02XURIDEN2 g in 1 PACKETGRANULE24
50633-330-30XURIDEN30 in 1 CARTONGRANULE304

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50633-330-02EA - Each50633-33000448f29-1c8a-4e7e-a3ae-fb529e24434212024-07-12
50633-330-30EA - Each50633-330a64685f1-4f7d-448b-b94a-f97b6e45093e12024-07-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50633-330XURIDEN (URIDINE TRIACETATE) GRANULE [BTG INTERNATIONAL INC]4Current NDC, 2 package rows20250221_88ca4d2b-3905-474b-9fd6-c81474f2fb4b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1665467uridine triacetate 2 GM Oral GranulesPSN88ca4d2b-3905-474b-9fd6-c81474f2fb4b4
1665473Xuriden 2 GM Oral GranulesPSN88ca4d2b-3905-474b-9fd6-c81474f2fb4b4
1665473uridine triacetate 2000 MG Oral Granules [Xuriden]SBD88ca4d2b-3905-474b-9fd6-c81474f2fb4b4
1665467uridine triacetate 2000 MG Oral GranulesSCD88ca4d2b-3905-474b-9fd6-c81474f2fb4b4
1665473Xuriden 2 GM Oral GranulesSY88ca4d2b-3905-474b-9fd6-c81474f2fb4b4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50633-330-02506330330022 g in 1 PACKET2 gHistorical
50633-330-305063303303030 PACKET in 1 CARTON (50633-330-30) / 2 g in 1 PACKET (50633-330-02) 30 packet2024-05-31NoNoHistorical