Home NDC 69468-152-02 XURIDEN
Product NDC 69468-152
Requested package NDC 69468-152-02
11-digit product format 694680152
Labeler code 69468
Product ID 69468-152_ad981e1e-0654-40b1-807a-f4e228c7ae11
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name uridine triacetate
Dosage form GRANULE
Route ORAL
Labeler Wellstat Therapeutics Corporation
Application NDA208169
Marketing category NDA
Marketing start 2015-09-08
Marketing end 0000-00-00
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 2023-12-31
Current FDA listing Historical FDA.report record 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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join XURIDEN URIDINE TRIACETATE BTG International Inc 88ca4d2b-3905-474b-9fd6-c81474f2fb4b 2025-02-18 Warnings, Adverse reactions Exact identifier application applno (NDA): 208169 application number: NDA208169
DailyMed Socrata Ingredients# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 69468-152-02 69468015202 2 g in 1 PACKET (69468-152-02) 2 g 2015-09-08 0000-00-00 No No Current