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 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 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 50633-330-02 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 50633-330-30 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 50633-330-30 ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 50633-330-02 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 50633-330-30 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 50633-330-02 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 50633-330-30 ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 50633-330-02 ad56d346431e…cc804d4bbf1e…
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# 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
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.
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