Univasc

Product NDC
0091-3707
11-digit product format
000913707
Labeler code
0091
Product ID
0091-3707_2c711a79-fc80-331d-e054-00144ff88e88
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
moexipril hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
UCB, Inc.
Application
NDA020312
Marketing category
NDA
Marketing start
1995-07-15
Marketing end
0000-00-00
Substance
MOEXIPRIL HYDROCHLORIDE
Active strength
8 mg/1
Pharmacologic classes
Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA]
NDC exclude flag
E
Listing certified through
2017-12-31
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 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct0091-3707IInactivated by FDA2026-08-10
excluded packagepackage0091-37070091-3707-01IInactivated by FDA2026-08-10
excluded packagepackage0091-37070091-3707-09IInactivated by FDA2026-08-10

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 2 · 66 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0091-3707-09d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0091-3707-01d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0091-3707-09f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0091-3707-01f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0091-3707-092ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0091-3707-012ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0091-3707-09a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0091-3707-01a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0091-3707-09cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0091-3707-01cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0091-3707-09cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0091-3707-01cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0091-3707-09302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0091-3707-01302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0091-3707-09ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0091-3707-01ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0091-3707-090efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0091-3707-010efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0091-3707-09ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0091-3707-01ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0091-3707-09367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0091-3707-01367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0091-3707-09557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0091-3707-01557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage0091-3707-098af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage0091-3707-018af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage0091-3707-09834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage0091-3707-01834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage0091-3707-091332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage0091-3707-011332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage0091-3707-09fb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage0091-3707-01fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage0091-3707-0986f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage0091-3707-0186f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage0091-3707-09bd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage0091-3707-01bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage0091-3707-098dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage0091-3707-018dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage0091-3707-09e2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage0091-3707-01e2bbac7714bc…27bdfed8d636…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
N020312-001UNIVASCMOEXIPRIL HYDROCHLORIDE7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORAL1995-04-19
N020312-002UNIVASCMOEXIPRIL HYDROCHLORIDE15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORAL1995-04-19

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 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N020312-001UNIVASC7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORAL1995-04-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020312-002UNIVASC15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORAL1995-04-19011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020312-001UNIVASC7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORAL1995-04-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020312-002UNIVASC15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORAL1995-04-1931067a03dcf5…
2025-08-23 18:47 UTC2025-08N020312-001UNIVASC7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORAL1995-04-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020312-002UNIVASC15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORAL1995-04-196a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020312-001UNIVASC7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORAL1995-04-19fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020312-002UNIVASC15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORAL1995-04-19fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020312-001UNIVASC7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORAL1995-04-19b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020312-002UNIVASC15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORAL1995-04-19b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020312-001UNIVASC7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORAL1995-04-1903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020312-002UNIVASC15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORAL1995-04-1903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020312-001UNIVASC7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORAL1995-04-192680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020312-002UNIVASC15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORAL1995-04-192680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020312-001UNIVASC7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORAL1995-04-195bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020312-002UNIVASC15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORAL1995-04-195bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020312-001UNIVASC7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORAL1995-04-19d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020312-002UNIVASC15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORAL1995-04-19d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N020312-001UNIVASC7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORAL1995-04-19d06236e962d9…
2024-10-29 15:01 UTC2024-10N020312-002UNIVASC15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORAL1995-04-19d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020312-001UNIVASC7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORAL1995-04-1979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020312-002UNIVASC15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORAL1995-04-1979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N020312-001UNIVASC7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORAL1995-04-19301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N020312-002UNIVASC15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORAL1995-04-19301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N020312-001UNIVASC7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORAL1995-04-191e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N020312-002UNIVASC15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORAL1995-04-191e350fbaab3a…
2024-05-31 18:47 UTC2024-05N020312-001UNIVASC7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORAL1995-04-198072bd15b7f6…
2024-05-31 18:47 UTC2024-05N020312-002UNIVASC15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORAL1995-04-198072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N020312-001UNIVASC7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORAL1995-04-195c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N020312-002UNIVASC15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORAL1995-04-195c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N020312-001UNIVASC7.5MGTABLET / ORAL1995-04-195d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N020312-002UNIVASC15MGTABLET / ORAL1995-04-195d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N020312-001UNIVASC7.5MGTABLET / ORAL1995-04-194b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N020312-002UNIVASC15MGTABLET / ORAL1995-04-194b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N020312-001UNIVASC7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**TABLET / ORAL1995-04-1974a2ff9319b5…
2019-12-13 00:20 UTC2019-12N020312-002UNIVASC15MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**TABLET / ORAL1995-04-1974a2ff9319b5…
2022-03-09 01:35 UTC2022-03N020312-001UNIVASC7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORAL1995-04-19bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N020312-002UNIVASC15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORAL1995-04-19bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N020312-001UNIVASC7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**TABLET / ORAL1995-04-19782e0a99824c…
2021-12-28 21:50 UTC2021-12N020312-002UNIVASC15MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**TABLET / ORAL1995-04-19782e0a99824c…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
041df61b-f8b6-48a6-7b67-411e1412678bProduct name120140508
af9cc3a2-6f01-38ca-6e6b-5199b2c3eeecProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0091-3707-012020-01-31C16284748780-19d75b9cf-dacf-f424-e053-dadaa90a57ceunivasc ® tablets (moexipril hydrochloride)
0091-3707-092020-01-31C16284748780-19d75b9cf-dacf-f424-e053-dadaa90a57ceunivasc ® tablets (moexipril hydrochloride)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0091-3707-01Univasc100 in 1 BOTTLETABLET, FILM COATED10010
0091-3707-09Univasc90 in 1 BOTTLETABLET, FILM COATED9010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0091-3707-01EA - Each0091-3707bb85f86d-397d-439f-9f81-a5215dbf4bfd12012-07-24

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0091-3707UNIVASC (MOEXIPRIL HYDROCHLORIDE) TABLET, FILM COATED [UCB, INC.]10Legacy NDC, 2 package rows20160223_e16c2ad3-1ce5-48fc-96b2-5d63dc6b68d5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1299896moexipril HCl 15 MG Oral TabletPSNe16c2ad3-1ce5-48fc-96b2-5d63dc6b68d510
1299897moexipril HCl 7.5 MG Oral TabletPSNe16c2ad3-1ce5-48fc-96b2-5d63dc6b68d510
1299963univasc 15 MG Oral TabletPSNe16c2ad3-1ce5-48fc-96b2-5d63dc6b68d510
1299965univasc 7.5 MG Oral TabletPSNe16c2ad3-1ce5-48fc-96b2-5d63dc6b68d510
1299963moexipril hydrochloride 15 MG Oral Tablet [Univasc]SBDe16c2ad3-1ce5-48fc-96b2-5d63dc6b68d510
1299965moexipril hydrochloride 7.5 MG Oral Tablet [Univasc]SBDe16c2ad3-1ce5-48fc-96b2-5d63dc6b68d510
1299896moexipril hydrochloride 15 MG Oral TabletSCDe16c2ad3-1ce5-48fc-96b2-5d63dc6b68d510
1299897moexipril hydrochloride 7.5 MG Oral TabletSCDe16c2ad3-1ce5-48fc-96b2-5d63dc6b68d510
1299963Univasc 15 MG Oral TabletSYe16c2ad3-1ce5-48fc-96b2-5d63dc6b68d510
1299965Univasc 7.5 MG Oral TabletSYe16c2ad3-1ce5-48fc-96b2-5d63dc6b68d510

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
0091-3707-0100091370701100 in 1 BOTTLEHistorical
0091-3707-090009137070990 in 1 BOTTLEHistorical