Home NDC 69468-151-10 VISTOGARD
Product NDC 69468-151
Requested package NDC 69468-151-10
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 Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 9 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Code, Status table Captured / source date Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 D Discontinued by firm 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
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.
Product history page 1 of 2 · 42 observed 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 2026-08-18 06:07:40 2026-07 N208159-001 VISTOGARD 10GM/PACKET GRANULE / ORAL RLD, RS 2015-12-11 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N208159-001 VISTOGARD 10GM/PACKET GRANULE / ORAL RLD, RS 2015-12-11 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208159-001 VISTOGARD 10GM/PACKET GRANULE / ORAL RLD, RS 2015-12-11 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N208159-001 VISTOGARD 10GM/PACKET GRANULE / ORAL RLD, RS 2015-12-11 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N208159-001 VISTOGARD 10GM/PACKET GRANULE / ORAL RLD, RS 2015-12-11 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N208159-001 VISTOGARD 10GM/PACKET GRANULE / ORAL RLD, RS 2015-12-11 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N208159-001 VISTOGARD 10GM/PACKET GRANULE / ORAL RLD, RS 2015-12-11 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N208159-001 VISTOGARD 10GM/PACKET GRANULE / ORAL RLD, RS 2015-12-11 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N208159-001 VISTOGARD 10GM/PACKET GRANULE / ORAL RLD, RS 2015-12-11 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N208159-001 VISTOGARD 10GM/PACKET GRANULE / ORAL RLD, RS 2015-12-11 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N208159-001 VISTOGARD 10GM/PACKET GRANULE / ORAL RLD, RS 2015-12-11 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N208159-001 VISTOGARD 10GM/PACKET GRANULE / ORAL RLD, RS 2015-12-11 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N208159-001 VISTOGARD 10GM/PACKET GRANULE / ORAL RLD, RS 2015-12-11 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N208159-001 VISTOGARD 10GM/PACKET GRANULE / ORAL RLD, RS 2015-12-11 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N208159-001 VISTOGARD 10GM/PACKET GRANULE / ORAL RLD, RS 2015-12-11 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N208159-001 VISTOGARD 10GM/PACKET GRANULE / ORAL RLD, RS 2015-12-11 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N208159-001 VISTOGARD 10GM/PACKET GRANULE / ORAL RLD, RS 2015-12-11 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N208159-001 VISTOGARD 10GM/PACKET GRANULE / ORAL RLD, RS 2015-12-11 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N208159-001 VISTOGARD 10GM/PACKET GRANULE / ORAL RLD, RS 2015-12-11 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N208159-001 VISTOGARD 10GM/PACKET GRANULE / ORAL RLD, RS 2015-12-11 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N208159-001 VISTOGARD 10GM/PACKET GRANULE / ORAL RLD, RS 2015-12-11 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N208159-001 VISTOGARD 10GM/PACKET GRANULE / ORAL RLD, RS 2015-12-11 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N208159-001 VISTOGARD 10GM/PACKET GRANULE / ORAL RLD, RS 2015-12-11 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N208159-001 VISTOGARD 10GM/PACKET GRANULE / ORAL RLD, RS 2015-12-11 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N208159-001 VISTOGARD 10GM/PACKET GRANULE / ORAL RLD, RS 2015-12-11 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N208159-001 VISTOGARD 10GM/PACKET GRANULE / ORAL RLD, RS 2015-12-11 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N208159-001 VISTOGARD 10GM/PACKET GRANULE / ORAL RLD, RS 2015-12-11 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N208159-001 VISTOGARD 10GM/PACKET GRANULE / ORAL RLD, RS 2015-12-11 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N208159-001 VISTOGARD 10GM/PACKET GRANULE / ORAL RLD, RS 2015-12-11 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N208159-001 VISTOGARD 10GM/PACKET GRANULE / ORAL RLD, RS 2015-12-11 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N208159-001 VISTOGARD 10GM/PACKET GRANULE / ORAL RLD, RS 2015-12-11 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N208159-001 VISTOGARD 10GM/PACKET GRANULE / ORAL RLD, RS 2015-12-11 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N208159-001 VISTOGARD 10GM/PACKET GRANULE / ORAL RLD, RS 2015-12-11 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N208159-001 VISTOGARD 10GM/PACKET GRANULE / ORAL RLD, RS 2015-12-11 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N208159-001 VISTOGARD 10GM/PACKET GRANULE / ORAL RLD, RS 2015-12-11 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N208159-001 VISTOGARD 10GM/PACKET GRANULE / ORAL RLD, RS 2015-12-11 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N208159-001 VISTOGARD 10GM/PACKET GRANULE / ORAL RLD, RS 2015-12-11 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N208159-001 VISTOGARD 10GM/PACKET GRANULE / ORAL RLD, RS 2015-12-11 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N208159-001 VISTOGARD 10GM/PACKET GRANULE / ORAL RLD, RS 2015-12-11 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N208159-001 VISTOGARD 10GM/PACKET GRANULE / ORAL RLD, RS 2015-12-11 e64feba35796…
Observed Orange Book patent history# Patent history page 1 of 2 · 66 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-08-18 06:07:40 2026-07 N208159-001 7776838 2027-08-17 U-1791 2015-12-16 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N208159-001 7776838 2027-08-17 U-1791 2015-12-16 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208159-001 7776838 2027-08-17 U-1791 2015-12-16 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N208159-001 7776838 2027-08-17 U-1791 2015-12-16 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N208159-001 7776838 2027-08-17 U-1791 2015-12-16 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N208159-001 7776838 2027-08-17 U-1791 2015-12-16 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N208159-001 7776838 2027-08-17 U-1791 2015-12-16 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N208159-001 7776838 2027-08-17 U-1791 2015-12-16 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N208159-001 7776838 2027-08-17 U-1791 2015-12-16 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N208159-001 7776838 2027-08-17 U-1791 2015-12-16 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N208159-001 7776838 2027-08-17 U-1791 2015-12-16 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N208159-001 7776838 2027-08-17 U-1791 2015-12-16 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N208159-001 7776838 2027-08-17 U-1791 2015-12-16 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N208159-001 7776838 2027-08-17 U-1791 2015-12-16 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N208159-001 7776838 2027-08-17 U-1791 2015-12-16 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N208159-001 6258795 2023-07-10 Drug product 2015-12-16 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N208159-001 7776838 2027-08-17 U-1791 2015-12-16 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N208159-001 6258795 2023-07-10 Drug product 2015-12-16 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N208159-001 7776838 2027-08-17 U-1791 2015-12-16 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N208159-001 6258795 2023-07-10 Drug product 2015-12-16 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N208159-001 7776838 2027-08-17 U-1791 2015-12-16 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N208159-001 6258795 2023-07-10 Drug product 2015-12-16 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N208159-001 7776838 2027-08-17 U-1791 2015-12-16 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N208159-001 6258795 2023-07-10 Drug product 2015-12-16 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N208159-001 7776838 2027-08-17 U-1791 2015-12-16 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N208159-001 6258795 2023-07-10 Drug product 2015-12-16 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N208159-001 7776838 2027-08-17 U-1791 2015-12-16 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N208159-001 6258795 2023-07-10 Drug product 2015-12-16 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N208159-001 7776838 2027-08-17 U-1791 2015-12-16 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N208159-001 6258795 2023-07-10 Drug product 2015-12-16 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 N208159-001 7776838 2027-08-17 U-1791 2015-12-16 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N208159-001 6258795 2023-07-10 Drug product 2015-12-16 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 N208159-001 7776838 2027-08-17 U-1791 2015-12-16 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N208159-001 6258795 2023-07-10 Drug product 2015-12-16 c0c555d07b60…2020-11-12 02:37 UTC 2020-11 N208159-001 7776838 2027-08-17 U-1791 2015-12-16 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N208159-001 6258795 2023-07-10 Drug product 2015-12-16 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N208159-001 7776838 2027-08-17 U-1791 2015-12-16 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N208159-001 6258795 2023-07-10 Drug product 2015-12-16 b00525d2431f…2019-09-15 20:21 UTC 2019-09 N208159-001 7776838 2027-08-17 U-1791 2015-12-16 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N208159-001 6258795 2023-07-10 Drug product 2015-12-16 ea99ee380514…
Observed Orange Book exclusivity history# openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown 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 69468-151-10 69468015110 10 g in 1 PACKET (69468-151-10) 10 g 2016-03-01 0000-00-00 No No Current