Application 020387

Type: NDA
Sponsor: MERCK SHARP DOHME

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	HYZAAR	HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM	TABLET;ORAL	12.5MG;50MG	Yes	No
002	HYZAAR	HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM	TABLET;ORAL	25MG;100MG	Yes	No
003	HYZAAR	HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM	TABLET;ORAL	12.5MG;100MG	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
N020387-001	HYZAAR	HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM	12.5MG;50MG	TABLET / ORAL	AB	RLD	1995-04-28
N020387-002	HYZAAR	HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM	25MG;100MG	TABLET / ORAL	AB	RLD	1998-11-10
N020387-003	HYZAAR	HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM	12.5MG;100MG	TABLET / ORAL	AB	RLD	2005-10-20

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N020387-001	AB
N020387-002	AB
N020387-003	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	N020387-001	HYZAAR	12.5MG;50MG	TABLET / ORAL	AB	RLD	1995-04-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020387-002	HYZAAR	25MG;100MG	TABLET / ORAL	AB	RLD	1998-11-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020387-003	HYZAAR	12.5MG;100MG	TABLET / ORAL	AB	RLD	2005-10-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020387-001	HYZAAR	12.5MG;50MG	TABLET / ORAL	AB	RLD	1995-04-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020387-002	HYZAAR	25MG;100MG	TABLET / ORAL	AB	RLD	1998-11-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020387-003	HYZAAR	12.5MG;100MG	TABLET / ORAL	AB	RLD	2005-10-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020387-001	HYZAAR	12.5MG;50MG	TABLET / ORAL	AB	RLD	1995-04-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020387-002	HYZAAR	25MG;100MG	TABLET / ORAL	AB	RLD	1998-11-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020387-003	HYZAAR	12.5MG;100MG	TABLET / ORAL	AB	RLD	2005-10-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020387-001	HYZAAR	12.5MG;50MG	TABLET / ORAL	AB	RLD	1995-04-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020387-002	HYZAAR	25MG;100MG	TABLET / ORAL	AB	RLD	1998-11-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020387-003	HYZAAR	12.5MG;100MG	TABLET / ORAL	AB	RLD	2005-10-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020387-001	HYZAAR	12.5MG;50MG	TABLET / ORAL	AB	RLD	1995-04-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020387-002	HYZAAR	25MG;100MG	TABLET / ORAL	AB	RLD	1998-11-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020387-003	HYZAAR	12.5MG;100MG	TABLET / ORAL	AB	RLD	2005-10-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020387-001	HYZAAR	12.5MG;50MG	TABLET / ORAL	AB	RLD	1995-04-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020387-002	HYZAAR	25MG;100MG	TABLET / ORAL	AB	RLD	1998-11-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020387-003	HYZAAR	12.5MG;100MG	TABLET / ORAL	AB	RLD	2005-10-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020387-001	HYZAAR	12.5MG;50MG	TABLET / ORAL	AB	RLD	1995-04-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020387-002	HYZAAR	25MG;100MG	TABLET / ORAL	AB	RLD	1998-11-10	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020387-003	HYZAAR	12.5MG;100MG	TABLET / ORAL	AB	RLD	2005-10-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020387-001	HYZAAR	12.5MG;50MG	TABLET / ORAL	AB	RLD	1995-04-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020387-002	HYZAAR	25MG;100MG	TABLET / ORAL	AB	RLD	1998-11-10	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020387-003	HYZAAR	12.5MG;100MG	TABLET / ORAL	AB	RLD	2005-10-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020387-001	HYZAAR	12.5MG;50MG	TABLET / ORAL	AB	RLD	1995-04-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020387-002	HYZAAR	25MG;100MG	TABLET / ORAL	AB	RLD	1998-11-10	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020387-003	HYZAAR	12.5MG;100MG	TABLET / ORAL	AB	RLD	2005-10-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020387-001	HYZAAR	12.5MG;50MG	TABLET / ORAL	AB	RLD	1995-04-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020387-002	HYZAAR	25MG;100MG	TABLET / ORAL	AB	RLD	1998-11-10	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020387-003	HYZAAR	12.5MG;100MG	TABLET / ORAL	AB	RLD	2005-10-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020387-001	HYZAAR	12.5MG;50MG	TABLET / ORAL	AB	RLD	1995-04-28	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020387-002	HYZAAR	25MG;100MG	TABLET / ORAL	AB	RLD	1998-11-10	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020387-003	HYZAAR	12.5MG;100MG	TABLET / ORAL	AB	RLD	2005-10-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020387-001	HYZAAR	12.5MG;50MG	TABLET / ORAL	AB	RLD	1995-04-28	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020387-002	HYZAAR	25MG;100MG	TABLET / ORAL	AB	RLD	1998-11-10	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020387-003	HYZAAR	12.5MG;100MG	TABLET / ORAL	AB	RLD	2005-10-20	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020387-001	HYZAAR	12.5MG;50MG	TABLET / ORAL	AB	RLD	1995-04-28	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020387-002	HYZAAR	25MG;100MG	TABLET / ORAL	AB	RLD	1998-11-10	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020387-003	HYZAAR	12.5MG;100MG	TABLET / ORAL	AB	RLD	2005-10-20	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020387-001	HYZAAR	12.5MG;50MG	TABLET / ORAL	AB	RLD	1995-04-28	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 107 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	N020387-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020387-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020387-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020387-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020387-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020387-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020387-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020387-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020387-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020387-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020387-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020387-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020387-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020387-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020387-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020387-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020387-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020387-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020387-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020387-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020387-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020387-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020387-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020387-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020387-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020387-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020387-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020387-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020387-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020387-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020387-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020387-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020387-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020387-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020387-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020387-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020387-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020387-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020387-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020387-001	AB	1	`8072bd15b7f6…`

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
HYZAAR	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	Organon LLC	4116ccde-2e23-45f4-b12f-6337df877744	2025-11-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 020387 application number: NDA020387 ndc (product): 78206-140 ndc (product): 78206-139 ndc (product): 78206-141

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 31 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0006-0717	HYZAAR	losartan potassium and hydrochlorothiazide	Merck Sharp & Dohme Corp.	NDA	Current
0006-0717	HYZAAR	losartan potassium and hydrochlorothiazide	Merck Sharp & Dohme Corp.	NDA	Current
0006-0717	HYZAAR	losartan potassium and hydrochlorothiazide	Merck Sharp & Dohme Corp.	NDA	Current
0006-0717	HYZAAR	losartan potassium and hydrochlorothiazide	Merck Sharp & Dohme Corp.	NDA	Current
0006-0745	HYZAAR	losartan potassium and hydrochlorothiazide	Merck Sharp & Dohme Corp.	NDA	Current
0006-0745	HYZAAR	losartan potassium and hydrochlorothiazide	Merck Sharp & Dohme Corp.	NDA	Current
0006-0745	HYZAAR	losartan potassium and hydrochlorothiazide	Merck Sharp & Dohme Corp.	NDA	Current
0006-0745	HYZAAR	losartan potassium and hydrochlorothiazide	Merck Sharp & Dohme Corp.	NDA	Current
0006-0747	HYZAAR	losartan potassium and hydrochlorothiazide	Merck Sharp & Dohme Corp.	NDA	Current
0006-0747	HYZAAR	losartan potassium and hydrochlorothiazide	Merck Sharp & Dohme Corp.	NDA	Current
0006-0747	HYZAAR	losartan potassium and hydrochlorothiazide	Merck Sharp & Dohme Corp.	NDA	Current
0006-0747	HYZAAR	losartan potassium and hydrochlorothiazide	Merck Sharp & Dohme Corp.	NDA	Current
0781-5816	losartan potassium and hydrochlorothiazide	losartan potassium and hydrochlorothiazide	Sandoz Inc.	NDA	Current
0781-5817	losartan potassium and hydrochlorothiazide	losartan potassium and hydrochlorothiazide	Sandoz Inc.	NDA	Current
0781-5818	losartan potassium and hydrochlorothiazide	losartan potassium and hydrochlorothiazide	Sandoz Inc.	NDA	Current
21695-788	HYZAAR	losartan potassium and hydrochlorothiazide	Rebel Distributors Corp	NDA	Current
43353-926	HYZAAR	losartan potassium and hydrochlorothiazide	Aphena Pharma Solutions - Tennessee, LLC	NDA	Current
55289-522	HYZAAR	losartan potassium and hydrochlorothiazide	PD-Rx Pharmaceuticals, In	NDA	Current
55289-522	HYZAAR	losartan potassium and hydrochlorothiazide	PD-Rx Pharmaceuticals, Inc.	NDA	Current
55289-522	HYZAAR	losartan potassium and hydrochlorothiazide	PD-Rx Pharmaceuticals, Inc.	NDA	Current
55289-522	HYZAAR	losartan potassium and hydrochlorothiazide	PD-Rx Pharmaceuticals, Inc.	NDA	Current
55289-522	HYZAAR	losartan potassium and hydrochlorothiazide	PD-Rx Pharmaceuticals, Inc.	NDA	Current
63629-3183	HYZAAR	losartan potassium and hydrochlorothiazide	Bryant Ranch Prepack	NDA	Current
63629-3183	HYZAAR	losartan potassium and hydrochlorothiazide	Bryant Ranch Prepack	NDA	Current
63629-3183	HYZAAR	losartan potassium and hydrochlorothiazide	Bryant Ranch Prepack	NDA	Current
78206-139	HYZAAR	losartan potassium and hydrochlorothiazide	Organon LLC	NDA	Current
78206-139	HYZAAR	losartan potassium and hydrochlorothiazide	Organon LLC	NDA	Current
78206-140	HYZAAR	losartan potassium and hydrochlorothiazide	Organon LLC	NDA	Current
78206-140	HYZAAR	losartan potassium and hydrochlorothiazide	Organon LLC	NDA	Current
78206-141	HYZAAR	losartan potassium and hydrochlorothiazide	Organon LLC	NDA	Current
78206-141	HYZAAR	losartan potassium and hydrochlorothiazide	Organon LLC	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
82663	SUPPL	2025-06-25
82643	SUPPL	2025-06-24
73805	SUPPL	2023-03-28
73812	SUPPL	2023-03-21
66563	SUPPL	2021-03-08
64399	SUPPL	2020-08-24
64335	SUPPL	2020-08-20
60847	SUPPL	2019-11-15
60814	SUPPL	2019-11-12
55966	SUPPL	2018-10-17
55910	SUPPL	2018-10-15
34594	SUPPL	2015-12-15
2458	SUPPL	2015-12-15
2462	SUPPL	2014-10-01
34596	SUPPL	2014-09-30
12528	SUPPL	2014-01-22
24897	SUPPL	2014-01-21
12527	SUPPL	2013-04-01
2461	SUPPL	2013-03-29
2460	SUPPL	2012-10-03
12526	SUPPL	2012-10-02
34595	SUPPL	2011-11-21
24895	SUPPL	2011-11-21
24896	SUPPL	2011-08-31
12525	SUPPL	2011-08-30
12524	SUPPL	2011-08-24
24894	SUPPL	2011-08-18
24893	SUPPL	2011-06-17
41328	SUPPL	2011-02-15
2459	SUPPL	2010-09-27
12523	SUPPL	2010-09-23
34593	SUPPL	2009-06-22
24892	SUPPL	2009-06-17
24890	SUPPL	2007-01-08
24891	SUPPL	2006-09-18
12522	SUPPL	2006-08-30
2457	SUPPL	2006-04-25
34592	SUPPL	2006-04-21
24889	SUPPL	2005-10-25
12521	SUPPL	2005-10-24
34591	SUPPL	2005-04-13
24888	SUPPL	2005-04-13
12520	SUPPL	2005-04-13
2456	SUPPL	2005-04-13
12519	SUPPL	2005-04-12
2455	SUPPL	2005-04-12
41326	SUPPL	2003-11-25
41324	SUPPL	2003-11-25
20628	SUPPL	2003-11-25
12517	SUPPL	2003-10-10
12516	SUPPL	2003-10-10
12518	SUPPL	2003-10-09
24887	SUPPL	2003-09-30
2454	SUPPL	2003-09-30
2453	SUPPL	2003-09-30
24886	SUPPL	2002-11-07
41322	SUPPL	2002-04-30
41325	SUPPL	2001-01-28
41327	SUPPL	2000-01-19
41323	SUPPL	1999-06-09
20627	SUPPL	1998-11-24
20625	SUPPL	1998-11-10
20626	SUPPL	1998-08-25
20624	SUPPL	1998-08-24
20623	SUPPL	1997-11-07