Home NDC 69468-151-20 VISTOGARD
Product NDC 69468-151
Requested package NDC 69468-151-20
11-digit product format 694680151
Labeler code 69468
Product ID 69468-151_8e64b577-1ecb-46f2-a7c8-3577a16f8837
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name uridine triacetate
Dosage form GRANULE
Route ORAL
Labeler Wellstat Therapeutics Corporation
Application NDA208159
Marketing category NDA
Marketing start 2016-03-01
Marketing end 0000-00-00
Substance URIDINE TRIACETATE
Active strength 951 mg/g
Pharmacologic classes Pyrimidine Analog [EPC],Pyrimidines [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient]
NDC exclude flag No
Listing certified through 2020-12-31
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 N208159-001 VISTOGARD URIDINE TRIACETATE 10GM/PACKET GRANULE / ORAL RLD, RS 2015-12-11
Orange Book patents# Current patent rows page 1 of 1 · 1 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N208159-001 7776838 2027-08-17 U-1791 2015-12-16
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 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 N208159-001 VISTOGARD 10GM/PACKET GRANULE / ORAL RLD, RS 2015-12-11 a50c72e98297…
Observed Orange Book patent history# Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-08-01 22:54:32 2026-06 N208159-001 7776838 2027-08-17 U-1791 2015-12-16 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 VISTOGARD URIDINE TRIACETATE BTG International Inc 269f7363-63ed-444e-85f1-f0009e44818b 2026-03-31 Warnings, Adverse reactions Exact identifier application applno (NDA): 208159 application number: NDA208159
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 69468-151-20 69468015120 20 PACKET in 1 CARTON (69468-151-20) > 10 g in 1 PACKET (69468-151-10) 20 packet 2016-03-01 0000-00-00 No No Current