Home NDC 69468-152 XURIDEN
Product NDC 69468-152
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 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 · 27 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 69468-152-02 D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 69468-152-30 D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 69468-152-02 D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 69468-152-30 D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 69468-152-02 D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 69468-152-30 D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 69468-152-02 D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 69468-152-30 D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 69468-152-02 D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 69468-152-30 D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 69468-152-02 D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 69468-152-30 D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product D Discontinued by firm 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 69468-152-02 D Discontinued by firm 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 69468-152-30 D Discontinued by firm 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 69468-152-30 U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 69468-152-02 U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 69468-152-30 U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 69468-152-02 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 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.
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 N208169-001 XURIDEN 2GM/PACKET GRANULE / ORAL RLD, RS 2015-09-04 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N208169-001 XURIDEN 2GM/PACKET GRANULE / ORAL RLD, RS 2015-09-04 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208169-001 XURIDEN 2GM/PACKET GRANULE / ORAL RLD, RS 2015-09-04 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N208169-001 XURIDEN 2GM/PACKET GRANULE / ORAL RLD, RS 2015-09-04 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N208169-001 XURIDEN 2GM/PACKET GRANULE / ORAL RLD, RS 2015-09-04 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N208169-001 XURIDEN 2GM/PACKET GRANULE / ORAL RLD, RS 2015-09-04 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N208169-001 XURIDEN 2GM/PACKET GRANULE / ORAL RLD, RS 2015-09-04 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N208169-001 XURIDEN 2GM/PACKET GRANULE / ORAL RLD, RS 2015-09-04 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N208169-001 XURIDEN 2GM/PACKET GRANULE / ORAL RLD, RS 2015-09-04 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N208169-001 XURIDEN 2GM/PACKET GRANULE / ORAL RLD, RS 2015-09-04 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N208169-001 XURIDEN 2GM/PACKET GRANULE / ORAL RLD, RS 2015-09-04 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N208169-001 XURIDEN 2GM/PACKET GRANULE / ORAL RLD, RS 2015-09-04 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N208169-001 XURIDEN 2GM/PACKET GRANULE / ORAL RLD, RS 2015-09-04 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N208169-001 XURIDEN 2GM/PACKET GRANULE / ORAL RLD, RS 2015-09-04 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N208169-001 XURIDEN 2GM/PACKET GRANULE / ORAL RLD, RS 2015-09-04 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N208169-001 XURIDEN 2GM/PACKET GRANULE / ORAL RLD, RS 2015-09-04 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N208169-001 XURIDEN 2GM/PACKET GRANULE / ORAL RLD, RS 2015-09-04 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N208169-001 XURIDEN 2GM/PACKET GRANULE / ORAL RLD, RS 2015-09-04 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N208169-001 XURIDEN 2GM/PACKET GRANULE / ORAL RLD, RS 2015-09-04 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N208169-001 XURIDEN 2GM/PACKET GRANULE / ORAL RLD, RS 2015-09-04 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N208169-001 XURIDEN 2GM/PACKET GRANULE / ORAL RLD, RS 2015-09-04 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N208169-001 XURIDEN 2GM/PACKET GRANULE / ORAL RLD, RS 2015-09-04 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N208169-001 XURIDEN 2GM/PACKET GRANULE / ORAL RLD, RS 2015-09-04 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N208169-001 XURIDEN 2GM/PACKET GRANULE / ORAL RLD, RS 2015-09-04 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N208169-001 XURIDEN 2GM/PACKET GRANULE / ORAL RLD, RS 2015-09-04 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N208169-001 XURIDEN 2GM/PACKET GRANULE / ORAL RLD, RS 2015-09-04 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N208169-001 XURIDEN 2GM/PACKET GRANULE / ORAL RLD, RS 2015-09-04 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N208169-001 XURIDEN 2GM/PACKET GRANULE / ORAL RLD, RS 2015-09-04 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N208169-001 XURIDEN 2GM/PACKET GRANULE / ORAL RLD, RS 2015-09-04 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N208169-001 XURIDEN 2GM/PACKET GRANULE / ORAL RLD, RS 2015-09-04 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N208169-001 XURIDEN 2GM/PACKET GRANULE / ORAL RLD, RS 2015-09-04 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N208169-001 XURIDEN 2GM/PACKET GRANULE / ORAL RLD, RS 2015-09-04 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N208169-001 XURIDEN 2GM/PACKET GRANULE / ORAL RLD, RS 2015-09-04 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N208169-001 XURIDEN 2GM/PACKET GRANULE / ORAL RLD, RS 2015-09-04 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N208169-001 XURIDEN 2GM/PACKET GRANULE / ORAL RLD, RS 2015-09-04 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N208169-001 XURIDEN 2GM/PACKET GRANULE / ORAL RLD, RS 2015-09-04 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N208169-001 XURIDEN 2GM/PACKET GRANULE / ORAL RLD, RS 2015-09-04 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N208169-001 XURIDEN 2GM/PACKET GRANULE / ORAL RLD, RS 2015-09-04 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N208169-001 XURIDEN 2GM/PACKET GRANULE / ORAL RLD, RS 2015-09-04 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N208169-001 XURIDEN 2GM/PACKET GRANULE / ORAL RLD, RS 2015-09-04 e64feba35796…
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 2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N208169-001 6258795 2023-07-10 Drug product 2015-10-22 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N208169-001 6258795 2023-07-10 Drug product 2015-10-22 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N208169-001 6258795 2023-07-10 Drug product 2015-10-22 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N208169-001 6258795 2023-07-10 Drug product 2015-10-22 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N208169-001 6258795 2023-07-10 Drug product 2015-10-22 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N208169-001 6258795 2023-07-10 Drug product 2015-10-22 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N208169-001 6258795 2023-07-10 Drug product 2015-10-22 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N208169-001 6258795 2023-07-10 Drug product 2015-10-22 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N208169-001 6258795 2023-07-10 Drug product 2015-10-22 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N208169-001 6258795 2023-07-10 Drug product 2015-10-22 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N208169-001 6258795 2023-07-10 Drug product 2015-10-22 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N208169-001 6258795 2023-07-10 Drug product 2015-10-22 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N208169-001 6258795 2023-07-10 Drug product 2015-10-22 ea99ee380514…2023-12-20 04:57 UTC 2023-12 N208169-001 6258795 2023-07-10 Drug product 2015-10-22 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N208169-001 6258795 2023-07-10 Drug product 2015-10-22 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N208169-001 6258795 2023-07-10 Drug product 2015-10-22 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N208169-001 6258795 2023-07-10 Drug product 2015-10-22 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N208169-001 6258795 2023-07-10 Drug product 2015-10-22 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N208169-001 6258795 2023-07-10 Drug product 2015-10-22 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N208169-001 6258795 2023-07-10 Drug product 2015-10-22 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N208169-001 6258795 2023-07-10 Drug product 2015-10-22 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N208169-001 6258795 2023-07-10 Drug product 2015-10-22 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N208169-001 6258795 2023-07-10 Drug product 2015-10-22 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N208169-001 6258795 2023-07-10 Drug product 2015-10-22 cb3db0bc1861…
Observed Orange Book exclusivity history# DailyMed Socrata Ingredients# 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 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
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 69468-152-30 69468015230 30 PACKET in 1 CARTON (69468-152-30) > 2 g in 1 PACKET 30 packet 2015-09-08 0000-00-00 No No Current