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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N208159-001VISTOGARDURIDINE TRIACETATE10GM/PACKETGRANULE / ORALRLD, RS2015-12-11

Orange Book patents#

Current patent rows page 1 of 1 · 1 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N208159-00177768382027-08-17U-17912015-12-16

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N208159-001VISTOGARD10GM/PACKETGRANULE / ORALRLD, RS2015-12-11011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N208159-001VISTOGARD10GM/PACKETGRANULE / ORALRLD, RS2015-12-1131067a03dcf5…
2025-08-23 18:47 UTC2025-08N208159-001VISTOGARD10GM/PACKETGRANULE / ORALRLD, RS2015-12-116a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N208159-001VISTOGARD10GM/PACKETGRANULE / ORALRLD, RS2015-12-11fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N208159-001VISTOGARD10GM/PACKETGRANULE / ORALRLD, RS2015-12-11b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N208159-001VISTOGARD10GM/PACKETGRANULE / ORALRLD, RS2015-12-1103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N208159-001VISTOGARD10GM/PACKETGRANULE / ORALRLD, RS2015-12-112680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N208159-001VISTOGARD10GM/PACKETGRANULE / ORALRLD, RS2015-12-115bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N208159-001VISTOGARD10GM/PACKETGRANULE / ORALRLD, RS2015-12-11d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N208159-001VISTOGARD10GM/PACKETGRANULE / ORALRLD, RS2015-12-11d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N208159-001VISTOGARD10GM/PACKETGRANULE / ORALRLD, RS2015-12-1179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N208159-001VISTOGARD10GM/PACKETGRANULE / ORALRLD, RS2015-12-11301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N208159-001VISTOGARD10GM/PACKETGRANULE / ORALRLD, RS2015-12-111e350fbaab3a…
2024-05-31 18:47 UTC2024-05N208159-001VISTOGARD10GM/PACKETGRANULE / ORALRLD, RS2015-12-118072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N208159-001VISTOGARD10GM/PACKETGRANULE / ORALRLD, RS2015-12-115c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N208159-001VISTOGARD10GM/PACKETGRANULE / ORALRLD, RS2015-12-115d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N208159-001VISTOGARD10GM/PACKETGRANULE / ORALRLD, RS2015-12-114b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N208159-001VISTOGARD10GM/PACKETGRANULE / ORALRLD, RS2015-12-1174a2ff9319b5…
2022-03-09 01:35 UTC2022-03N208159-001VISTOGARD10GM/PACKETGRANULE / ORALRLD, RS2015-12-11bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N208159-001VISTOGARD10GM/PACKETGRANULE / ORALRLD, RS2015-12-11782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N208159-001VISTOGARD10GM/PACKETGRANULE / ORALRLD, RS2015-12-1187673890dc5c…
2021-03-12 10:30 UTC2021-03N208159-001VISTOGARD10GM/PACKETGRANULE / ORALRLD, RS2015-12-115aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N208159-001VISTOGARD10GM/PACKETGRANULE / ORALRLD, RS2015-12-118869cabd3fbd…
2020-11-12 02:37 UTC2020-11N208159-001VISTOGARD10GM/PACKETGRANULE / ORALRLD, RS2015-12-11c0c555d07b60…
2019-12-14 00:12 UTC2019-12N208159-001VISTOGARD10GM/PACKETGRANULE / ORALRLD, RS2015-12-113f01610625f2…
2019-09-15 20:21 UTC2019-09N208159-001VISTOGARD10GM/PACKETGRANULE / ORALRLD, RS2015-12-11b00525d2431f…
2019-07-19 19:46 UTC2019-07N208159-001VISTOGARD10GM/PACKETGRANULE / ORALRLD, RS2015-12-11ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N208159-001VISTOGARD10GM/PACKETGRANULE / ORALRLD, RS2015-12-116a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N208159-001VISTOGARD10GM/PACKETGRANULE / ORALRLD, RS2015-12-111c564ffb4f44…
2023-12-20 04:57 UTC2023-12N208159-001VISTOGARD10GM/PACKETGRANULE / ORALRLD, RS2015-12-11ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N208159-001VISTOGARD10GM/PACKETGRANULE / ORALRLD, RS2015-12-11a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N208159-001VISTOGARD10GM/PACKETGRANULE / ORALRLD, RS2015-12-119b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N208159-001VISTOGARD10GM/PACKETGRANULE / ORALRLD, RS2015-12-11a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N208159-001VISTOGARD10GM/PACKETGRANULE / ORALRLD, RS2015-12-113f0d92c62455…
2023-05-13 08:27 UTC2023-05N208159-001VISTOGARD10GM/PACKETGRANULE / ORALRLD, RS2015-12-11053a50430f4f…
2023-01-26 05:58 UTC2023-01N208159-001VISTOGARD10GM/PACKETGRANULE / ORALRLD, RS2015-12-113bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N208159-001VISTOGARD10GM/PACKETGRANULE / ORALRLD, RS2015-12-113a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N208159-001VISTOGARD10GM/PACKETGRANULE / ORALRLD, RS2015-12-11f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N208159-001VISTOGARD10GM/PACKETGRANULE / ORALRLD, RS2015-12-11e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N208159-001VISTOGARD10GM/PACKETGRANULE / ORALRLD, RS2015-12-11cb3db0bc1861…

Observed Orange Book patent history#

Patent history page 1 of 2 · 65 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-02-19 14:30 UTC2026-02N208159-00177768382027-08-17U-17912015-12-16011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N208159-00177768382027-08-17U-17912015-12-1631067a03dcf5…
2025-08-23 18:47 UTC2025-08N208159-00177768382027-08-17U-17912015-12-166a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N208159-00177768382027-08-17U-17912015-12-16fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N208159-00177768382027-08-17U-17912015-12-16b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N208159-00177768382027-08-17U-17912015-12-1603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N208159-00177768382027-08-17U-17912015-12-162680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N208159-00177768382027-08-17U-17912015-12-165bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N208159-00177768382027-08-17U-17912015-12-16d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N208159-00177768382027-08-17U-17912015-12-16d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N208159-00177768382027-08-17U-17912015-12-1679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N208159-00177768382027-08-17U-17912015-12-16301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N208159-00177768382027-08-17U-17912015-12-161e350fbaab3a…
2024-05-31 18:47 UTC2024-05N208159-00177768382027-08-17U-17912015-12-168072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N208159-00162587952023-07-10Drug product2015-12-165c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N208159-00177768382027-08-17U-17912015-12-165c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N208159-00162587952023-07-10Drug product2015-12-165d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N208159-00177768382027-08-17U-17912015-12-165d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N208159-00162587952023-07-10Drug product2015-12-164b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N208159-00177768382027-08-17U-17912015-12-164b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N208159-00162587952023-07-10Drug product2015-12-1674a2ff9319b5…
2019-12-13 00:20 UTC2019-12N208159-00177768382027-08-17U-17912015-12-1674a2ff9319b5…
2022-03-09 01:35 UTC2022-03N208159-00162587952023-07-10Drug product2015-12-16bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N208159-00177768382027-08-17U-17912015-12-16bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N208159-00162587952023-07-10Drug product2015-12-16782e0a99824c…
2021-12-28 21:50 UTC2021-12N208159-00177768382027-08-17U-17912015-12-16782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N208159-00162587952023-07-10Drug product2015-12-1687673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N208159-00177768382027-08-17U-17912015-12-1687673890dc5c…
2021-03-12 10:30 UTC2021-03N208159-00162587952023-07-10Drug product2015-12-165aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03N208159-00177768382027-08-17U-17912015-12-165aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N208159-00162587952023-07-10Drug product2015-12-168869cabd3fbd…
2020-12-22 03:56 UTC2020-12N208159-00177768382027-08-17U-17912015-12-168869cabd3fbd…
2020-11-12 02:37 UTC2020-11N208159-00162587952023-07-10Drug product2015-12-16c0c555d07b60…
2020-11-12 02:37 UTC2020-11N208159-00177768382027-08-17U-17912015-12-16c0c555d07b60…
2019-12-14 00:12 UTC2019-12N208159-00162587952023-07-10Drug product2015-12-163f01610625f2…
2019-12-14 00:12 UTC2019-12N208159-00177768382027-08-17U-17912015-12-163f01610625f2…
2019-09-15 20:21 UTC2019-09N208159-00162587952023-07-10Drug product2015-12-16b00525d2431f…
2019-09-15 20:21 UTC2019-09N208159-00177768382027-08-17U-17912015-12-16b00525d2431f…
2019-07-19 19:46 UTC2019-07N208159-00162587952023-07-10Drug product2015-12-16ea99ee380514…
2019-07-19 19:46 UTC2019-07N208159-00177768382027-08-17U-17912015-12-16ea99ee380514…

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N208159-001ODE-1042022-12-115c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N208159-001ODE-1042022-12-115d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N208159-001ODE-1042022-12-114b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N208159-001NCE2020-09-0474a2ff9319b5…
2019-12-13 00:20 UTC2019-12N208159-001ODE-1042022-12-1174a2ff9319b5…
2022-03-09 01:35 UTC2022-03N208159-001ODE-1042022-12-11bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N208159-001ODE-1042022-12-11782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N208159-001ODE-1042022-12-1187673890dc5c…
2021-03-12 10:30 UTC2021-03N208159-001ODE-1042022-12-115aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N208159-001NCE2020-09-048869cabd3fbd…
2020-12-22 03:56 UTC2020-12N208159-001ODE-1042022-12-118869cabd3fbd…
2020-11-12 02:37 UTC2020-11N208159-001NCE2020-09-04c0c555d07b60…
2020-11-12 02:37 UTC2020-11N208159-001ODE-1042022-12-11c0c555d07b60…
2019-12-14 00:12 UTC2019-12N208159-001NCE2020-09-043f01610625f2…
2019-12-14 00:12 UTC2019-12N208159-001ODE-1042022-12-113f01610625f2…
2019-09-15 20:21 UTC2019-09N208159-001NCE2020-09-04b00525d2431f…
2019-09-15 20:21 UTC2019-09N208159-001ODE-1042022-12-11b00525d2431f…
2019-07-19 19:46 UTC2019-07N208159-001NCE2020-09-04ea99ee380514…
2019-07-19 19:46 UTC2019-07N208159-001ODE-1042022-12-11ea99ee380514…
2023-01-26 05:58 UTC2023-01N208159-001ODE-1042022-12-113bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N208159-001ODE-1042022-12-113a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N208159-001ODE-1042022-12-11f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N208159-001ODE-1042022-12-11e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N208159-001ODE-1042022-12-11cb3db0bc1861…

Additional Listing Data#

Finished product
Yes
Brand name base
VISTOGARD
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
URIDINE TRIACETATE951 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2WP61F175MInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1739794Internal RxNorm lookup
1739800Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
269f7363-63ed-444e-85f1-f0009e44818bAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
aef517b6-a1af-4b03-aa34-2de7d01970b0Product name120151218
befe3fd1-a84f-4723-b9ec-997073cb5483Product name120151105

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50633-220-04VISTOGARD4 in 1 CARTONGRANULE43
50633-220-10VISTOGARD10 g in 1 PACKETGRANULE103
50633-220-20VISTOGARD20 in 1 CARTONGRANULE203

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50633-220-04EA - Each50633-220c27858f1-4531-455b-9c0a-3bb4f432010b12024-09-09
50633-220-20EA - Each50633-220b8cadbd1-edab-4ed5-92b3-3a1dbfefb32f12024-09-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50633-220VISTOGARD (URIDINE TRIACETATE) GRANULE [BTG INTERNATIONAL INC]2Current NDC, 3 package rows20250210_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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
VISTOGARDURIDINE TRIACETATEBTG International Inc269f7363-63ed-444e-85f1-f0009e44818b2026-03-31Warnings, Adverse reactionsExact identifier
application applno (NDA): 208159
application number: NDA208159
ndc (package): 50633-220-04
ndc (product): 50633-220
ndc11 (package): 50633022004

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1739794uridine triacetate 10 GM Oral GranulesPSN269f7363-63ed-444e-85f1-f0009e44818b3
1739800VISTOGARD 10 GM Oral GranulesPSN269f7363-63ed-444e-85f1-f0009e44818b3
1739800uridine triacetate 10000 MG Oral Granules [Vistogard]SBD269f7363-63ed-444e-85f1-f0009e44818b3
1739794uridine triacetate 10000 MG Oral GranulesSCD269f7363-63ed-444e-85f1-f0009e44818b3
1739800Vistogard 10 GM Oral GranulesSY269f7363-63ed-444e-85f1-f0009e44818b3
1739800Vistogard 10,000 MG Oral GranulesSY269f7363-63ed-444e-85f1-f0009e44818b3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50633-220-04506330220044 PACKET in 1 CARTON (50633-220-04) / 10 g in 1 PACKET (50633-220-10) 4 packet2024-07-31NoNoCurrent