Home NDC 50633-330 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 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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N208169-001 XURIDEN URIDINE TRIACETATE 2GM/PACKET GRANULE / ORAL RLD, RS 2015-09-04
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-01 22:54:32 2026-06 N208169-001 XURIDEN 2GM/PACKET GRANULE / ORAL RLD, RS 2015-09-04 a50c72e98297…
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.
Additional Listing Data#
Finished product Yes
Brand name base XURIDEN
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength URIDINE TRIACETATE 951 mg/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2WP61F175M Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1665467 Internal RxNorm lookup 1665473 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 50633-330-02 XURIDEN 2 g in 1 PACKET GRANULE 2 4 50633-330-30 XURIDEN 30 in 1 CARTON GRANULE 30 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50633-330 XURIDEN (URIDINE TRIACETATE) GRANULE [BTG INTERNATIONAL INC] 4 Current NDC, 2 package rows 20250221_88ca4d2b-3905-474b-9fd6-c81474f2fb4b.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 50633-330-02 50633033002 2 g in 1 PACKET 2 g Historical 50633-330-30 50633033030 30 PACKET in 1 CARTON (50633-330-30) / 2 g in 1 PACKET (50633-330-02) 30 packet 2024-05-31 No No Current