Application 018303

Type: NDA
Sponsor: US PHARMS HOLDINGS I

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	LOPRESSOR HCT	HYDROCHLOROTHIAZIDE; METOPROLOL TARTRATE	TABLET;ORAL	25MG;50MG	Yes	No
002	LOPRESSOR HCT	HYDROCHLOROTHIAZIDE; METOPROLOL TARTRATE	TABLET;ORAL	25MG;100MG	Yes	Yes
003	LOPRESSOR HCT	HYDROCHLOROTHIAZIDE; METOPROLOL TARTRATE	TABLET;ORAL	50MG;100MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No

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

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N018303-001	LOPRESSOR HCT	HYDROCHLOROTHIAZIDE; METOPROLOL TARTRATE	25MG;50MG	TABLET / ORAL	AB	RLD	1984-12-31
N018303-002	LOPRESSOR HCT	HYDROCHLOROTHIAZIDE; METOPROLOL TARTRATE	25MG;100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1984-12-31
N018303-003	LOPRESSOR HCT	HYDROCHLOROTHIAZIDE; METOPROLOL TARTRATE	50MG;100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1984-12-31

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N018303-001	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 4 · 123 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
2026-02-19 14:30 UTC	2026-02	N018303-001	LOPRESSOR HCT	25MG;50MG	TABLET / ORAL	AB	RLD	1984-12-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018303-002	LOPRESSOR HCT	25MG;100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1984-12-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018303-003	LOPRESSOR HCT	50MG;100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1984-12-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018303-001	LOPRESSOR HCT	25MG;50MG	TABLET / ORAL	AB	RLD	1984-12-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018303-002	LOPRESSOR HCT	25MG;100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1984-12-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018303-003	LOPRESSOR HCT	50MG;100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1984-12-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N018303-001	LOPRESSOR HCT	25MG;50MG	TABLET / ORAL	AB	RLD	1984-12-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N018303-002	LOPRESSOR HCT	25MG;100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1984-12-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N018303-003	LOPRESSOR HCT	50MG;100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1984-12-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018303-001	LOPRESSOR HCT	25MG;50MG	TABLET / ORAL	AB	RLD	1984-12-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018303-002	LOPRESSOR HCT	25MG;100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1984-12-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018303-003	LOPRESSOR HCT	50MG;100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1984-12-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018303-001	LOPRESSOR HCT	25MG;50MG	TABLET / ORAL	AB	RLD	1984-12-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018303-002	LOPRESSOR HCT	25MG;100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1984-12-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018303-003	LOPRESSOR HCT	50MG;100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1984-12-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018303-001	LOPRESSOR HCT	25MG;50MG	TABLET / ORAL	AB	RLD	1984-12-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018303-002	LOPRESSOR HCT	25MG;100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1984-12-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018303-003	LOPRESSOR HCT	50MG;100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1984-12-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018303-001	LOPRESSOR HCT	25MG;50MG	TABLET / ORAL	AB	RLD	1984-12-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018303-002	LOPRESSOR HCT	25MG;100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1984-12-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018303-003	LOPRESSOR HCT	50MG;100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1984-12-31	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018303-001	LOPRESSOR HCT	25MG;50MG	TABLET / ORAL	AB	RLD	1984-12-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018303-002	LOPRESSOR HCT	25MG;100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1984-12-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018303-003	LOPRESSOR HCT	50MG;100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1984-12-31	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018303-001	LOPRESSOR HCT	25MG;50MG	TABLET / ORAL	AB	RLD	1984-12-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018303-002	LOPRESSOR HCT	25MG;100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1984-12-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018303-003	LOPRESSOR HCT	50MG;100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1984-12-31	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N018303-001	LOPRESSOR HCT	25MG;50MG	TABLET / ORAL	AB	RLD	1984-12-31	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N018303-002	LOPRESSOR HCT	25MG;100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1984-12-31	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N018303-003	LOPRESSOR HCT	50MG;100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1984-12-31	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N018303-001	LOPRESSOR HCT	25MG;50MG	TABLET / ORAL	AB	RLD	1984-12-31	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N018303-002	LOPRESSOR HCT	25MG;100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1984-12-31	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N018303-003	LOPRESSOR HCT	50MG;100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1984-12-31	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N018303-001	LOPRESSOR HCT	25MG;50MG	TABLET / ORAL	AB	RLD	1984-12-31	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N018303-002	LOPRESSOR HCT	25MG;100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1984-12-31	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N018303-003	LOPRESSOR HCT	50MG;100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1984-12-31	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N018303-001	LOPRESSOR HCT	25MG;50MG	TABLET / ORAL	AB	RLD	1984-12-31	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N018303-002	LOPRESSOR HCT	25MG;100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1984-12-31	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N018303-003	LOPRESSOR HCT	50MG;100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1984-12-31	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N018303-001	LOPRESSOR HCT	25MG;50MG	TABLET / ORAL	AB	RLD	1984-12-31	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 45 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N018303-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018303-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N018303-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018303-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018303-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018303-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018303-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018303-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018303-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N018303-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N018303-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N018303-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N018303-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N018303-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N018303-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N018303-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N018303-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N018303-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N018303-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N018303-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N018303-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N018303-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N018303-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N018303-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N018303-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N018303-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N018303-002	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N018303-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N018303-002	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N018303-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N018303-002	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N018303-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N018303-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N018303-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N018303-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N018303-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N018303-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N018303-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N018303-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N018303-001	AB	1	`3bdfa0b2c4d7…`

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
LOPRESSOR	METOPROLOL TARTRATE	VALIDUS PHARMACEUTICALS LLC	b5f4fed2-369c-4808-a682-8a5b8cfdbb4f	2026-01-26	Warnings, Adverse reactions	Exact identifier ndc (product): 30698-460

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
30698-460	Lopressor HCT	metoprolol tartrate and hydrochlorothiazide	Validus Pharmaceuticals LLC	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
77157	SUPPL	2023-12-27
77131	SUPPL	2023-12-27
71010	SUPPL	2022-05-06
70976	SUPPL	2022-05-04
64387	SUPPL	2020-08-24
64337	SUPPL	2020-08-21
33473	SUPPL	2011-03-21
11201	SUPPL	2011-03-21
896	SUPPL	2010-01-06
33472	SUPPL	2009-09-17
895	SUPPL	2008-08-13
33471	SUPPL	2008-07-29
14976	SUPPL	2008-01-09
11200	SUPPL	2008-01-08
894	SUPPL	2006-09-18
14975	SUPPL	2003-11-25