Vimovo

Product NDC
75987-030
Requested package NDC
75987-030-73
11-digit product format
759870030
Labeler code
75987
Product ID
75987-030_3d7e5e03-f6bb-4b2a-b0ba-d0c3886ac81c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Naproxen and Esomeprazole Magnesium
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Horizon Therapeutics USA, Inc.
Application
NDA022511
Marketing category
NDA
Marketing start
2010-07-06
Marketing end
0000-00-00
Substance
ESOMEPRAZOLE MAGNESIUM; NAPROXEN
Active strength
20 mg/1; mg/1
Pharmacologic classes
Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Cytochrome P450 2C19 Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage75987-03075987-030-73DDiscontinued by firm2026-08-17

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 · 1 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage75987-03075987-030-73DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N022511-001VIMOVOESOMEPRAZOLE MAGNESIUM; NAPROXENEQ 20MG BASE;500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, DELAYED RELEASE / ORALRLD2010-04-30
N022511-002VIMOVOESOMEPRAZOLE MAGNESIUM; NAPROXENEQ 20MG BASE;375MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, DELAYED RELEASE / ORALRLD2010-04-30

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 3 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07N022511-001VIMOVOEQ 20MG BASE;500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, DELAYED RELEASE / ORALRLD2010-04-30caaa826d4ba7…
2026-08-18 06:07:402026-07N022511-002VIMOVOEQ 20MG BASE;375MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, DELAYED RELEASE / ORALRLD2010-04-30caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N022511-001VIMOVOEQ 20MG BASE;500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, DELAYED RELEASE / ORALRLD2010-04-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022511-002VIMOVOEQ 20MG BASE;375MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, DELAYED RELEASE / ORALRLD2010-04-30011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022511-001VIMOVOEQ 20MG BASE;500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, DELAYED RELEASE / ORALRLD2010-04-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022511-002VIMOVOEQ 20MG BASE;375MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, DELAYED RELEASE / ORALRLD2010-04-3031067a03dcf5…
2025-08-23 18:47 UTC2025-08N022511-001VIMOVOEQ 20MG BASE;500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, DELAYED RELEASE / ORALRLD2010-04-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08N022511-002VIMOVOEQ 20MG BASE;375MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, DELAYED RELEASE / ORALRLD2010-04-306a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022511-001VIMOVOEQ 20MG BASE;500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, DELAYED RELEASE / ORALRLD2010-04-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022511-002VIMOVOEQ 20MG BASE;375MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, DELAYED RELEASE / ORALRLD2010-04-30fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022511-001VIMOVOEQ 20MG BASE;500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, DELAYED RELEASE / ORALRLD2010-04-30b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022511-002VIMOVOEQ 20MG BASE;375MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, DELAYED RELEASE / ORALRLD2010-04-30b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022511-001VIMOVOEQ 20MG BASE;500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, DELAYED RELEASE / ORALRLD2010-04-3003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022511-002VIMOVOEQ 20MG BASE;375MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, DELAYED RELEASE / ORALRLD2010-04-3003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N022511-001VIMOVOEQ 20MG BASE;500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, DELAYED RELEASE / ORALRLD2010-04-302680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N022511-002VIMOVOEQ 20MG BASE;375MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, DELAYED RELEASE / ORALRLD2010-04-302680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N022511-001VIMOVOEQ 20MG BASE;500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, DELAYED RELEASE / ORALRLD2010-04-305bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N022511-002VIMOVOEQ 20MG BASE;375MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, DELAYED RELEASE / ORALRLD2010-04-305bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N022511-001VIMOVOEQ 20MG BASE;500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, DELAYED RELEASE / ORALRLD2010-04-30d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N022511-002VIMOVOEQ 20MG BASE;375MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, DELAYED RELEASE / ORALRLD2010-04-30d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N022511-001VIMOVOEQ 20MG BASE;500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, DELAYED RELEASE / ORALRLD2010-04-30d06236e962d9…
2024-10-29 15:01 UTC2024-10N022511-002VIMOVOEQ 20MG BASE;375MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, DELAYED RELEASE / ORALRLD2010-04-30d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N022511-001VIMOVOEQ 20MG BASE;500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, DELAYED RELEASE / ORALRLD2010-04-3079d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N022511-002VIMOVOEQ 20MG BASE;375MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, DELAYED RELEASE / ORALRLD2010-04-3079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N022511-001VIMOVOEQ 20MG BASE;500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, DELAYED RELEASE / ORALRLD2010-04-30301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N022511-002VIMOVOEQ 20MG BASE;375MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, DELAYED RELEASE / ORALRLD2010-04-30301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N022511-001VIMOVOEQ 20MG BASE;500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, DELAYED RELEASE / ORALRLD2010-04-301e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N022511-002VIMOVOEQ 20MG BASE;375MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, DELAYED RELEASE / ORALRLD2010-04-301e350fbaab3a…
2024-05-31 18:47 UTC2024-05N022511-001VIMOVOEQ 20MG BASE;500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, DELAYED RELEASE / ORALRLD2010-04-308072bd15b7f6…
2024-05-31 18:47 UTC2024-05N022511-002VIMOVOEQ 20MG BASE;375MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, DELAYED RELEASE / ORALRLD2010-04-308072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N022511-001VIMOVOEQ 20MG BASE;500MGTABLET, DELAYED RELEASE / ORALABRLD, RS2010-04-305c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N022511-002VIMOVOEQ 20MG BASE;375MGTABLET, DELAYED RELEASE / ORALABRLD2010-04-305c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N022511-001VIMOVOEQ 20MG BASE;500MGTABLET, DELAYED RELEASE / ORALABRLD, RS2010-04-305d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N022511-002VIMOVOEQ 20MG BASE;375MGTABLET, DELAYED RELEASE / ORALABRLD2010-04-305d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N022511-001VIMOVOEQ 20MG BASE;500MGTABLET, DELAYED RELEASE / ORALABRLD, RS2010-04-304b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N022511-002VIMOVOEQ 20MG BASE;375MGTABLET, DELAYED RELEASE / ORALABRLD2010-04-304b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N022511-001VIMOVOEQ 20MG BASE;500MGTABLET, DELAYED RELEASE / ORALRLD, RS2010-04-3074a2ff9319b5…
2019-12-13 00:20 UTC2019-12N022511-002VIMOVOEQ 20MG BASE;375MGTABLET, DELAYED RELEASE / ORALRLD2010-04-3074a2ff9319b5…
2022-03-09 01:35 UTC2022-03N022511-001VIMOVOEQ 20MG BASE;500MGTABLET, DELAYED RELEASE / ORALABRLD, RS2010-04-30bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N022511-002VIMOVOEQ 20MG BASE;375MGTABLET, DELAYED RELEASE / ORALABRLD2010-04-30bb7c543d1eb4…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N022511-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N022511-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N022511-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N022511-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N022511-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N022511-002AB14b0b4de00fa7…
2022-03-09 01:35 UTC2022-03N022511-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N022511-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N022511-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12N022511-002AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N022511-001AB187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N022511-002AB187673890dc5c…
2021-03-12 10:30 UTC2021-03N022511-001AB15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03N022511-002AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N022511-001AB18869cabd3fbd…
2020-12-22 03:56 UTC2020-12N022511-002AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11N022511-001AB1c0c555d07b60…
2020-11-12 02:37 UTC2020-11N022511-002AB1c0c555d07b60…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N022511-001AB1a67488948f0b…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N022511-002AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N022511-001AB13f0d92c62455…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N022511-002AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05N022511-001AB1053a50430f4f…
2023-05-13 08:27 UTC2023-05N022511-002AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01N022511-001AB13bdfa0b2c4d7…
2023-01-26 05:58 UTC2023-01N022511-002AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N022511-001AB13a93d1ddd44b…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N022511-002AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N022511-001AB1f41ea6bd6efb…
2022-10-28 04:53 UTC2022-10N022511-002AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N022511-001AB1e64feba35796…
2022-09-29 23:25 UTC2022-09N022511-002AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N022511-001AB1cb3db0bc1861…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N022511-002AB1cb3db0bc1861…

Observed Orange Book patent history#

Patent history page 1 of 10 · 380 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N022511-00188526362022-05-31U-1052Drug product2014-10-295c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N022511-00188589962022-05-31U-1052Drug product2014-10-295c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N022511-00191619202022-05-31U-17602015-11-125c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N022511-00191988882022-05-31U-17812015-12-175c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N022511-00193456952022-05-31Drug product2016-06-235c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N022511-00197071812022-05-31Drug product2017-08-175c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N022511-00193932082029-09-03U-17812016-08-175c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N022511-00192206982031-03-10U-17812016-01-285c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N022511-00189456212031-10-17U-16612015-03-025c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N022511-00288526362022-05-31U-1052Drug product2014-10-295c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N022511-00288589962022-05-31U-1052Drug product2014-10-295c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N022511-00291619202022-05-31U-17602015-11-125c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N022511-00291988882022-05-31U-17812015-12-175c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N022511-00293456952022-05-31Drug product2016-06-235c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N022511-00297071812022-05-31Drug product2017-08-175c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N022511-00293932082029-09-03U-17812016-08-175c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N022511-00289456212031-10-17U-16612015-03-025c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N022511-00188526362022-05-31U-1052Drug product2014-10-295d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N022511-00188589962022-05-31U-1052Drug product2014-10-295d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N022511-00191619202022-05-31U-17602015-11-125d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N022511-00191988882022-05-31U-17812015-12-175d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N022511-00193456952022-05-31Drug product2016-06-235d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N022511-00197071812022-05-31Drug product2017-08-175d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N022511-00193932082029-09-03U-17812016-08-175d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N022511-00192206982031-03-10U-17812016-01-285d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N022511-00189456212031-10-17U-16612015-03-025d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N022511-00288526362022-05-31U-1052Drug product2014-10-295d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N022511-00288589962022-05-31U-1052Drug product2014-10-295d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N022511-00291619202022-05-31U-17602015-11-125d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N022511-00291988882022-05-31U-17812015-12-175d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N022511-00293456952022-05-31Drug product2016-06-235d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N022511-00297071812022-05-31Drug product2017-08-175d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N022511-00293932082029-09-03U-17812016-08-175d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N022511-00289456212031-10-17U-16612015-03-025d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N022511-00185572852022-05-31Drug product2013-10-294b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N022511-00188526362022-05-31U-1052Drug product2014-10-294b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N022511-00188589962022-05-31U-1052Drug product2014-10-294b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N022511-00191619202022-05-31U-17602015-11-124b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N022511-00191988882022-05-31U-17812015-12-174b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N022511-00193456952022-05-31Drug product2016-06-234b0b4de00fa7…

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2019-12-13 00:20 UTC2019-12N022511-001NPP2020-07-0674a2ff9319b5…
2019-12-13 00:20 UTC2019-12N022511-002NPP2020-07-0674a2ff9319b5…
2020-12-22 03:56 UTC2020-12N022511-001NPP2020-07-068869cabd3fbd…
2020-12-22 03:56 UTC2020-12N022511-002NPP2020-07-068869cabd3fbd…
2020-11-12 02:37 UTC2020-11N022511-001NPP2020-07-06c0c555d07b60…
2020-11-12 02:37 UTC2020-11N022511-002NPP2020-07-06c0c555d07b60…
2019-12-14 00:12 UTC2019-12N022511-001NPP2020-07-063f01610625f2…
2019-12-14 00:12 UTC2019-12N022511-002NPP2020-07-063f01610625f2…
2019-09-15 20:21 UTC2019-09N022511-001NPP2020-07-06b00525d2431f…
2019-09-15 20:21 UTC2019-09N022511-002NPP2020-07-06b00525d2431f…
2019-07-19 19:46 UTC2019-07N022511-001NPP2020-07-06ea99ee380514…
2019-07-19 19:46 UTC2019-07N022511-002NPP2020-07-06ea99ee380514…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
75987-030-04EA - Each75987-030afdb181b-0733-45d7-90f0-8e4fe88fb8a912014-01-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Esomeprazole MagnesiumACTIVE INGREDIENTR6DXU4WAY9VIMOVO (NAPROXEN AND ESOMEPRAZOLE MAGNESIUM) TABLET, DELAYED RELEASE [HORIZON PHARMA INC.]5
NaproxenACTIVE INGREDIENT57Y76R9ATQVIMOVO (NAPROXEN AND ESOMEPRAZOLE MAGNESIUM) TABLET, DELAYED RELEASE [HORIZON PHARMA INC.]5
EsomeprazoleACTIVE MOIETYN3PA6559FTVIMOVO (NAPROXEN AND ESOMEPRAZOLE MAGNESIUM) TABLET, DELAYED RELEASE [HORIZON PHARMA INC.]5
NaproxenACTIVE MOIETY57Y76R9ATQVIMOVO (NAPROXEN AND ESOMEPRAZOLE MAGNESIUM) TABLET, DELAYED RELEASE [HORIZON PHARMA INC.]5
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZVIMOVO (NAPROXEN AND ESOMEPRAZOLE MAGNESIUM) TABLET, DELAYED RELEASE [HORIZON PHARMA INC.]5
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48VIMOVO (NAPROXEN AND ESOMEPRAZOLE MAGNESIUM) TABLET, DELAYED RELEASE [HORIZON PHARMA INC.]5
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTVIMOVO (NAPROXEN AND ESOMEPRAZOLE MAGNESIUM) TABLET, DELAYED RELEASE [HORIZON PHARMA INC.]5
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357VIMOVO (NAPROXEN AND ESOMEPRAZOLE MAGNESIUM) TABLET, DELAYED RELEASE [HORIZON PHARMA INC.]5
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE4VIMOVO (NAPROXEN AND ESOMEPRAZOLE MAGNESIUM) TABLET, DELAYED RELEASE [HORIZON PHARMA INC.]5
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOVIMOVO (NAPROXEN AND ESOMEPRAZOLE MAGNESIUM) TABLET, DELAYED RELEASE [HORIZON PHARMA INC.]5
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30VIMOVO (NAPROXEN AND ESOMEPRAZOLE MAGNESIUM) TABLET, DELAYED RELEASE [HORIZON PHARMA INC.]5
METHACRYLIC ACIDINACTIVE INGREDIENT1CS02G8656VIMOVO (NAPROXEN AND ESOMEPRAZOLE MAGNESIUM) TABLET, DELAYED RELEASE [HORIZON PHARMA INC.]5
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TVIMOVO (NAPROXEN AND ESOMEPRAZOLE MAGNESIUM) TABLET, DELAYED RELEASE [HORIZON PHARMA INC.]5
POLYDEXTROSEINACTIVE INGREDIENTVH2XOU12IEVIMOVO (NAPROXEN AND ESOMEPRAZOLE MAGNESIUM) TABLET, DELAYED RELEASE [HORIZON PHARMA INC.]5
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AVIMOVO (NAPROXEN AND ESOMEPRAZOLE MAGNESIUM) TABLET, DELAYED RELEASE [HORIZON PHARMA INC.]5
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HVIMOVO (NAPROXEN AND ESOMEPRAZOLE MAGNESIUM) TABLET, DELAYED RELEASE [HORIZON PHARMA INC.]5
POVIDONESINACTIVE INGREDIENTFZ989GH94EVIMOVO (NAPROXEN AND ESOMEPRAZOLE MAGNESIUM) TABLET, DELAYED RELEASE [HORIZON PHARMA INC.]5
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHVIMOVO (NAPROXEN AND ESOMEPRAZOLE MAGNESIUM) TABLET, DELAYED RELEASE [HORIZON PHARMA INC.]5
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4VIMOVO (NAPROXEN AND ESOMEPRAZOLE MAGNESIUM) TABLET, DELAYED RELEASE [HORIZON PHARMA INC.]5
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPVIMOVO (NAPROXEN AND ESOMEPRAZOLE MAGNESIUM) TABLET, DELAYED RELEASE [HORIZON PHARMA INC.]5
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMVIMOVO (NAPROXEN AND ESOMEPRAZOLE MAGNESIUM) TABLET, DELAYED RELEASE [HORIZON PHARMA INC.]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
75987-030VIMOVO (NAPROXEN AND ESOMEPRAZOLE MAGNESIUM) TABLET, DELAYED RELEASE [HORIZON THERAPEUTICS USA, INC.]17Legacy NDC20241207_baa47781-7151-4c75-a9a2-d2eac0a7d55e.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
75987-030-73759870030731 BOTTLE in 1 CARTON (75987-030-73) > 6 TABLET, DELAYED RELEASE in 1 BOTTLE1 bottle2010-07-060000-00-00NoNoCurrent