Application 020312

Type: NDA
Sponsor: UCB INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	UNIVASC	MOEXIPRIL HYDROCHLORIDE	TABLET;ORAL	7.5MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	No	No
002	UNIVASC	MOEXIPRIL HYDROCHLORIDE	TABLET;ORAL	15MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	No	No

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-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N020312-001	UNIVASC	MOEXIPRIL HYDROCHLORIDE	7.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL			1995-04-19
N020312-002	UNIVASC	MOEXIPRIL HYDROCHLORIDE	15MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL			1995-04-19

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
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N020312-001	UNIVASC	7.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	1995-04-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020312-002	UNIVASC	15MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	1995-04-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020312-001	UNIVASC	7.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	1995-04-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020312-002	UNIVASC	15MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	1995-04-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020312-001	UNIVASC	7.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	1995-04-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020312-002	UNIVASC	15MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	1995-04-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020312-001	UNIVASC	7.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	1995-04-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020312-002	UNIVASC	15MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	1995-04-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020312-001	UNIVASC	7.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	1995-04-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020312-002	UNIVASC	15MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	1995-04-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020312-001	UNIVASC	7.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	1995-04-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020312-002	UNIVASC	15MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	1995-04-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020312-001	UNIVASC	7.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	1995-04-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020312-002	UNIVASC	15MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	1995-04-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020312-001	UNIVASC	7.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	1995-04-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020312-002	UNIVASC	15MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	1995-04-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020312-001	UNIVASC	7.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	1995-04-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020312-002	UNIVASC	15MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	1995-04-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020312-001	UNIVASC	7.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	1995-04-19	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020312-002	UNIVASC	15MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	1995-04-19	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020312-001	UNIVASC	7.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	1995-04-19	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020312-002	UNIVASC	15MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	1995-04-19	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020312-001	UNIVASC	7.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	1995-04-19	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020312-002	UNIVASC	15MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	1995-04-19	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020312-001	UNIVASC	7.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	1995-04-19	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020312-002	UNIVASC	15MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	1995-04-19	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020312-001	UNIVASC	7.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	1995-04-19	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N020312-002	UNIVASC	15MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	1995-04-19	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020312-001	UNIVASC	7.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	1995-04-19	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020312-002	UNIVASC	15MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	1995-04-19	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020312-001	UNIVASC	7.5MG	TABLET / ORAL	1995-04-19	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N020312-002	UNIVASC	15MG	TABLET / ORAL	1995-04-19	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020312-001	UNIVASC	7.5MG	TABLET / ORAL	1995-04-19	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N020312-002	UNIVASC	15MG	TABLET / ORAL	1995-04-19	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020312-001	UNIVASC	7.5MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	1995-04-19	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020312-002	UNIVASC	15MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	1995-04-19	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020312-001	UNIVASC	7.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	1995-04-19	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N020312-002	UNIVASC	15MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	1995-04-19	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020312-001	UNIVASC	7.5MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	1995-04-19	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N020312-002	UNIVASC	15MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	1995-04-19	`782e0a99824c…`

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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Moexipril Hydrochloride	MOEXIPRIL HYDROCHLORIDE	Glenmark Pharmaceuticals Inc., USA	baac91ad-f8ee-4694-89f8-5c47a8eda39a	2026-01-23	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MOEXIPRIL HYDROCHLORIDE
Moexipril Hydrochloride	MOEXIPRIL HYDROCHLORIDE	Chartwell RX, LLC	5c24072c-9769-4cb5-b8da-bf814d21391d	2025-03-10	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MOEXIPRIL HYDROCHLORIDE
Moexipril Hydrochloride	MOEXIPRIL HYDROCHLORIDE	Teva Pharmaceuticals USA, Inc.	5d4078f3-b621-475f-a4e6-005de2e62b32	2015-08-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MOEXIPRIL HYDROCHLORIDE

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 1 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0091-3707	Univasc	moexipril hydrochloride	UCB, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
24764	SUPPL	2012-09-18
12438	SUPPL	2012-09-18
12437	SUPPL	2012-01-23
2324	SUPPL	2012-01-23
12436	SUPPL	2011-09-02
24763	SUPPL	2011-08-26
12435	SUPPL	2010-01-29
24762	SUPPL	2010-01-15
23575	ORIG	2006-06-09
2323	SUPPL	2003-11-25
41278	ORIG	2002-09-13
2322	SUPPL	2001-04-11
57395	ORIG	1995-04-19