Application 019851

Type: NDA
Sponsor: US PHARMS HOLDINGS I

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	LOTENSIN	BENAZEPRIL HYDROCHLORIDE	TABLET;ORAL	5MG	Yes	No
002	LOTENSIN	BENAZEPRIL HYDROCHLORIDE	TABLET;ORAL	10MG	Yes	No
003	LOTENSIN	BENAZEPRIL HYDROCHLORIDE	TABLET;ORAL	20MG	Yes	No
004	LOTENSIN	BENAZEPRIL HYDROCHLORIDE	TABLET;ORAL	40MG	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N019851-001	LOTENSIN	BENAZEPRIL HYDROCHLORIDE	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1991-06-25
N019851-002	LOTENSIN	BENAZEPRIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	RLD	1991-06-25
N019851-003	LOTENSIN	BENAZEPRIL HYDROCHLORIDE	20MG	TABLET / ORAL	AB	RLD	1991-06-25
N019851-004	LOTENSIN	BENAZEPRIL HYDROCHLORIDE	40MG	TABLET / ORAL	AB	RLD	1991-06-25

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
N019851-002	AB
N019851-003	AB
N019851-004	AB

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 5 · 172 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
2026-09-14 22:38:34	2026-08	N019851-001	LOTENSIN	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1991-06-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N019851-002	LOTENSIN	10MG	TABLET / ORAL	AB	RLD	1991-06-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N019851-003	LOTENSIN	20MG	TABLET / ORAL	AB	RLD	1991-06-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N019851-004	LOTENSIN	40MG	TABLET / ORAL	AB	RLD	1991-06-25	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N019851-001	LOTENSIN	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1991-06-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N019851-002	LOTENSIN	10MG	TABLET / ORAL	AB	RLD	1991-06-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N019851-003	LOTENSIN	20MG	TABLET / ORAL	AB	RLD	1991-06-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N019851-004	LOTENSIN	40MG	TABLET / ORAL	AB	RLD	1991-06-25	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N019851-001	LOTENSIN	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1991-06-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019851-002	LOTENSIN	10MG	TABLET / ORAL	AB	RLD	1991-06-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019851-003	LOTENSIN	20MG	TABLET / ORAL	AB	RLD	1991-06-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019851-004	LOTENSIN	40MG	TABLET / ORAL	AB	RLD	1991-06-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019851-001	LOTENSIN	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1991-06-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019851-002	LOTENSIN	10MG	TABLET / ORAL	AB	RLD	1991-06-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019851-003	LOTENSIN	20MG	TABLET / ORAL	AB	RLD	1991-06-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019851-004	LOTENSIN	40MG	TABLET / ORAL	AB	RLD	1991-06-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N019851-001	LOTENSIN	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1991-06-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019851-002	LOTENSIN	10MG	TABLET / ORAL	AB	RLD	1991-06-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019851-003	LOTENSIN	20MG	TABLET / ORAL	AB	RLD	1991-06-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019851-004	LOTENSIN	40MG	TABLET / ORAL	AB	RLD	1991-06-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019851-001	LOTENSIN	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1991-06-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019851-002	LOTENSIN	10MG	TABLET / ORAL	AB	RLD	1991-06-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019851-003	LOTENSIN	20MG	TABLET / ORAL	AB	RLD	1991-06-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019851-004	LOTENSIN	40MG	TABLET / ORAL	AB	RLD	1991-06-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019851-001	LOTENSIN	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1991-06-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019851-002	LOTENSIN	10MG	TABLET / ORAL	AB	RLD	1991-06-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019851-003	LOTENSIN	20MG	TABLET / ORAL	AB	RLD	1991-06-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019851-004	LOTENSIN	40MG	TABLET / ORAL	AB	RLD	1991-06-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019851-001	LOTENSIN	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1991-06-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019851-002	LOTENSIN	10MG	TABLET / ORAL	AB	RLD	1991-06-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019851-003	LOTENSIN	20MG	TABLET / ORAL	AB	RLD	1991-06-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019851-004	LOTENSIN	40MG	TABLET / ORAL	AB	RLD	1991-06-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019851-001	LOTENSIN	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1991-06-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019851-002	LOTENSIN	10MG	TABLET / ORAL	AB	RLD	1991-06-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019851-003	LOTENSIN	20MG	TABLET / ORAL	AB	RLD	1991-06-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019851-004	LOTENSIN	40MG	TABLET / ORAL	AB	RLD	1991-06-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019851-001	LOTENSIN	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1991-06-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019851-002	LOTENSIN	10MG	TABLET / ORAL	AB	RLD	1991-06-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019851-003	LOTENSIN	20MG	TABLET / ORAL	AB	RLD	1991-06-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019851-004	LOTENSIN	40MG	TABLET / ORAL	AB	RLD	1991-06-25	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 142 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	N019851-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N019851-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N019851-004	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N019851-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N019851-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N019851-004	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N019851-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019851-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019851-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019851-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019851-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019851-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N019851-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019851-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019851-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019851-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019851-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019851-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019851-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019851-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019851-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019851-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019851-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019851-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019851-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019851-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019851-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019851-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019851-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019851-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019851-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019851-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019851-004	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N019851-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N019851-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N019851-004	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019851-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019851-003	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019851-004	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019851-002	AB	1	`301d65b070ca…`

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Lotensin	BENAZEPRIL HYDROCHLORIDE	Validus Pharmaceuticals LLC	2abb091b-a53e-46b0-9b84-e5ee8f2bdd8e	2025-09-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 019851 application number: NDA019851 ndc (product): 30698-448 ndc (product): 30698-449 ndc (product): 30698-450

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 9 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
30698-448	Lotensin	benazepril hydrochloride	Validus Pharmaceuticals LLC	NDA	Current
30698-448	Lotensin	benazepril hydrochloride	Validus Pharmaceuticals LLC	NDA	Current
30698-448	Lotensin	benazepril hydrochloride	Validus Pharmaceuticals LLC	NDA	Current
30698-449	Lotensin	benazepril hydrochloride	Validus Pharmaceuticals LLC	NDA	Current
30698-449	Lotensin	benazepril hydrochloride	Validus Pharmaceuticals LLC	NDA	Current
30698-449	Lotensin	benazepril hydrochloride	Validus Pharmaceuticals LLC	NDA	Current
30698-450	Lotensin	benazepril hydrochloride	Validus Pharmaceuticals LLC	NDA	Current
30698-450	Lotensin	benazepril hydrochloride	Validus Pharmaceuticals LLC	NDA	Current
30698-450	Lotensin	benazepril hydrochloride	Validus Pharmaceuticals LLC	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
57433	SUPPL	2019-02-04
57159	SUPPL	2019-01-09
49266	SUPPL	2017-08-07
49252	SUPPL	2017-08-07
34035	SUPPL	2015-07-24
11780	SUPPL	2015-07-24
19759	SUPPL	2015-07-23
1712	SUPPL	2015-07-23
34034	SUPPL	2015-01-30
19758	SUPPL	2015-01-27
34033	SUPPL	2014-12-16
19757	SUPPL	2014-12-15
34032	SUPPL	2012-09-25
34030	SUPPL	2012-05-22
19755	SUPPL	2012-05-21
19756	SUPPL	2012-02-06
34031	SUPPL	2012-01-23
11779	SUPPL	2011-06-16
1711	SUPPL	2011-06-16
1710	SUPPL	2010-01-07
34029	SUPPL	2009-11-16
19754	SUPPL	2009-01-26
1709	SUPPL	2008-06-02
1708	SUPPL	2007-02-12
44037	ORIG	2006-06-09
11778	SUPPL	2004-04-05
1706	SUPPL	2004-03-03
1707	SUPPL	2003-11-05
51783	ORIG	1900-01-01
51782	ORIG	1900-01-01
51781	ORIG	1900-01-01
51780	ORIG	1900-01-01
51779	ORIG	1900-01-01