Home NDC 50633-220-04 VISTOGARD
Product NDC 50633-220
Requested package NDC 50633-220-04
11-digit product format 506330220
Labeler code 50633
Product ID 50633-220_4e4e69bd-abb4-4632-e063-6394a90ab642
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name uridine triacetate
Dosage form GRANULE
Route ORAL
Labeler BTG International Inc
Application NDA208159
Marketing category NDA
Marketing start 2024-07-31
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 2027-12-31
Current FDA listing Yes 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.
Product history page 1 of 2 · 41 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 2026-02-19 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…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N208159-001 VISTOGARD 10GM/PACKET GRANULE / ORAL RLD, RS 2015-12-11 cb3db0bc1861…
Observed Orange Book patent history# Patent history page 1 of 2 · 65 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 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…2019-07-19 19:46 UTC 2019-07 N208159-001 7776838 2027-08-17 U-1791 2015-12-16 ea99ee380514…
Observed Orange Book exclusivity history# Additional Listing Data#
Finished product Yes
Brand name base VISTOGARD
Listing expiration 2027-12-31 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 1739794 Internal RxNorm lookup 1739800 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 50633-220-04 VISTOGARD 4 in 1 CARTON GRANULE 4 3 50633-220-10 VISTOGARD 10 g in 1 PACKET GRANULE 10 3 50633-220-20 VISTOGARD 20 in 1 CARTON GRANULE 20 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50633-220 VISTOGARD (URIDINE TRIACETATE) GRANULE [BTG INTERNATIONAL INC] 2 Current NDC, 3 package rows 20250210_269f7363-63ed-444e-85f1-f0009e44818b.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 50633-220-04 50633022004 4 PACKET in 1 CARTON (50633-220-04) / 10 g in 1 PACKET (50633-220-10) 4 packet 2024-07-31 No No Current