Losartan Potassium and Hydrochlorothiazide

Product NDC: 71335-2127
11-digit product format: 713352127
Labeler code: 71335
Product ID: 71335-2127_9fb29467-4366-4f70-9f7f-72c3acede1e9
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: losartan potassium and hydrochlorothiazide
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: ANDA204901
Marketing category: ANDA
Marketing start: 2018-02-15
Substance: HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM
Active strength: 12.5; 50 mg/1; mg/1
Pharmacologic classes: Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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	Approval date
A204901-001	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM	12.5MG;50MG	TABLET / ORAL	AB	2017-11-06
A204901-002	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM	12.5MG;100MG	TABLET / ORAL	AB	2017-11-06
A204901-003	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM	25MG;100MG	TABLET / ORAL	AB	2017-11-06

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A204901-001	AB
A204901-002	AB
A204901-003	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 · 126 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A204901-001	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	12.5MG;50MG	TABLET / ORAL	AB	2017-11-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204901-002	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	12.5MG;100MG	TABLET / ORAL	AB	2017-11-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204901-003	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	25MG;100MG	TABLET / ORAL	AB	2017-11-06	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A204901-001	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	12.5MG;50MG	TABLET / ORAL	AB	2017-11-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204901-002	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	12.5MG;100MG	TABLET / ORAL	AB	2017-11-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204901-003	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	25MG;100MG	TABLET / ORAL	AB	2017-11-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204901-001	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	12.5MG;50MG	TABLET / ORAL	AB	2017-11-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204901-002	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	12.5MG;100MG	TABLET / ORAL	AB	2017-11-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204901-003	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	25MG;100MG	TABLET / ORAL	AB	2017-11-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204901-001	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	12.5MG;50MG	TABLET / ORAL	AB	2017-11-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204901-002	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	12.5MG;100MG	TABLET / ORAL	AB	2017-11-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204901-003	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	25MG;100MG	TABLET / ORAL	AB	2017-11-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204901-001	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	12.5MG;50MG	TABLET / ORAL	AB	2017-11-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204901-002	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	12.5MG;100MG	TABLET / ORAL	AB	2017-11-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204901-003	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	25MG;100MG	TABLET / ORAL	AB	2017-11-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204901-001	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	12.5MG;50MG	TABLET / ORAL	AB	2017-11-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204901-002	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	12.5MG;100MG	TABLET / ORAL	AB	2017-11-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204901-003	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	25MG;100MG	TABLET / ORAL	AB	2017-11-06	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204901-001	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	12.5MG;50MG	TABLET / ORAL	AB	2017-11-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204901-002	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	12.5MG;100MG	TABLET / ORAL	AB	2017-11-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204901-003	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	25MG;100MG	TABLET / ORAL	AB	2017-11-06	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204901-001	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	12.5MG;50MG	TABLET / ORAL	AB	2017-11-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204901-002	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	12.5MG;100MG	TABLET / ORAL	AB	2017-11-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204901-003	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	25MG;100MG	TABLET / ORAL	AB	2017-11-06	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204901-001	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	12.5MG;50MG	TABLET / ORAL	AB	2017-11-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204901-002	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	12.5MG;100MG	TABLET / ORAL	AB	2017-11-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204901-003	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	25MG;100MG	TABLET / ORAL	AB	2017-11-06	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204901-001	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	12.5MG;50MG	TABLET / ORAL	AB	2017-11-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204901-002	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	12.5MG;100MG	TABLET / ORAL	AB	2017-11-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204901-003	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	25MG;100MG	TABLET / ORAL	AB	2017-11-06	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204901-001	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	12.5MG;50MG	TABLET / ORAL	AB	2017-11-06	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204901-002	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	12.5MG;100MG	TABLET / ORAL	AB	2017-11-06	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204901-003	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	25MG;100MG	TABLET / ORAL	AB	2017-11-06	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204901-001	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	12.5MG;50MG	TABLET / ORAL	AB	2017-11-06	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204901-002	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	12.5MG;100MG	TABLET / ORAL	AB	2017-11-06	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204901-003	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	25MG;100MG	TABLET / ORAL	AB	2017-11-06	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204901-001	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	12.5MG;50MG	TABLET / ORAL	AB	2017-11-06	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204901-002	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	12.5MG;100MG	TABLET / ORAL	AB	2017-11-06	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204901-003	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	25MG;100MG	TABLET / ORAL	AB	2017-11-06	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204901-001	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	12.5MG;50MG	TABLET / ORAL	AB	2017-11-06	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 126 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A204901-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204901-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204901-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A204901-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204901-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204901-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204901-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204901-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204901-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204901-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204901-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204901-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204901-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204901-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204901-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204901-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204901-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204901-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204901-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204901-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204901-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204901-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204901-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204901-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204901-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204901-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204901-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204901-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204901-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204901-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204901-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204901-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204901-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204901-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204901-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204901-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204901-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204901-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204901-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204901-001	AB	1	`1e350fbaab3a…`

Additional Listing Data#

Finished product: Yes
Brand name base: Losartan Potassium and Hydrochlorothiazide
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
LOSARTAN POTASSIUM	12.5 mg/1
HYDROCHLOROTHIAZIDE	50 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
3ST302B24A	Internal UNII lookup
0J48LPH2TH	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
979468	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
42942482-1f54-4c7f-9d5f-4aaf20abb3e3	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
c19ec24d-2c40-4b8d-7c20-500ffa3660a1	Product name	3	20260303
0d341e63-aee5-498b-bf9a-b53a43963acf	Product name	1	20260105
1199f4b7-b537-466c-9a1c-cb09131e9f8b	Product name	1	20251117
e1a63b6e-1877-c2c1-01a3-03ea2817aa6f	Product name	3	20251027
b15e9aa6-d523-ca97-480e-570e0543a342	Product name	4	20251024
96816964-c075-ffa7-b7b8-d8570411a3b9	Product name	7	20250305
de29c5c0-90ba-29da-d7ab-0500274708be	Product name	6	20241009
162cbc9d-ecc3-72ba-af9f-c76e2756ef54	Product name	3	20221207
9b303cd4-3186-2454-5706-3137e8b2dfd2	Product name	4	20221110
47fc2fe9-7afb-4be9-989d-787aaa6ad0ea	Product name	1	20200505
a8e65197-7914-7acf-c7ec-914d53819b34	Product name	3	20190624
8b67f333-47d1-8464-7ce4-406d3dbb295f	Product name	7	20190618
89a57420-ab44-5323-14f9-595159145f9b	Product name	2	20190612
c27b049d-3258-48cf-ebe5-08c236ae78e2	Product name	3	20190610
00fc2cf9-672f-3e0b-6afa-43cbc864d058	Product name	4	20180613
15b375b1-89c7-9594-80df-5a8c8864aee0	Product name	3	20180108
a7349398-661d-d9fc-46df-7e128bbd61d9	Product name	5	20171113
1bdb87cf-9b1f-6a51-5eb7-d182aaffaa3d	Product name	2	20170719
e0eeb018-194e-4b70-a57d-bac47a97b8ea	Product name	1	20160825
55bffd21-17e1-ff02-2e8f-1f9a532b9502	Product name	2	20150320
ea069444-e874-4c28-833f-d2f52734ef4d	Product name	1	20150206
041df61b-f8b6-48a6-7b67-411e1412678b	Product name	1	20140508
0ad8bdca-888e-00da-648b-6a4de854a167	Product name	1	20140508
433a3439-b8f3-d13a-d2c8-9b221d628d60	Product name	1	20140508
59212689-39e5-a976-6d21-882d76d8079a	Product name	1	20140508
7613b1a5-acb6-4e5e-6048-c44deeeb1212	Product name	1	20140508
78637fb0-95c8-441f-e4b4-db1274b6f956	Product name	1	20140508
df89bd47-2db4-d593-ab37-d11953fd5536	Product name	1	20140508
f151007d-265d-9fbe-857d-1d44f1cb76ba	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
71335-2127-1	Losartan Potassium and Hydrochlorothiazide	90 in 1 BOTTLE	TABLET, FILM COATED	90	101
71335-2127-2	Losartan Potassium and Hydrochlorothiazide	60 in 1 BOTTLE	TABLET, FILM COATED	60	101
71335-2127-3	Losartan Potassium and Hydrochlorothiazide	30 in 1 BOTTLE	TABLET, FILM COATED	30	101
71335-2127-4	Losartan Potassium and Hydrochlorothiazide	120 in 1 BOTTLE	TABLET, FILM COATED	120	101
71335-2127-5	Losartan Potassium and Hydrochlorothiazide	58 in 1 BOTTLE	TABLET, FILM COATED	58	101
71335-2127-6	Losartan Potassium and Hydrochlorothiazide	100 in 1 BOTTLE	TABLET, FILM COATED	100	101
71335-2127-7	Losartan Potassium and Hydrochlorothiazide	180 in 1 BOTTLE	TABLET, FILM COATED	180	101
71335-2127-8	Losartan Potassium and Hydrochlorothiazide	1000 in 1 BOTTLE	TABLET, FILM COATED	1000	101

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71335-2127	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [BRYANT RANCH PREPACK]	101	Current NDC, Legacy NDC, 8 package rows	20231117_42942482-1f54-4c7f-9d5f-4aaf20abb3e3.zip

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 · 19 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Losartan Potassium and Hydrochlorothiazide	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	REMEDYREPACK INC.	fd07d24c-6db1-4f6b-b226-68abba3a3321	2026-08-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204901 application number: ANDA204901
Losartan Potassium and Hydrochlorothiazide	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	REMEDYREPACK INC.	446e6998-01f6-4de0-be57-7fecf5448e95	2026-08-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204901 application number: ANDA204901
Losartan Potassium and Hydrochlorothiazide	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	St. Mary's Medical Park Pharmacy	eac57b4c-e79b-8d35-e053-2a95a90a9d25	2026-06-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204901 application number: ANDA204901
Losartan Potassium and Hydrochlorothiazide	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	QPharma, Inc	499208e5-21ab-d4fe-e063-6294a90a9a78	2026-05-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204901 application number: ANDA204901
Losartan Potassium and Hydrochlorothiazide	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	REMEDYREPACK INC.	03c0ec8d-9daf-43e8-8a4e-a2ddc3573ca7	2026-04-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204901 application number: ANDA204901
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	Direct Rx	d838e918-2463-79f6-e053-2a95a90a948d	2026-03-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204901 application number: ANDA204901
Losartan Potassium and Hydrochlorothiazide	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	Solco Healthcare US, LLC	6d677f9e-c0e4-4d6e-bea2-a58e986e4635	2025-11-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204901 application number: ANDA204901
Losartan Potassium and Hydrochlorothiazide	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	Proficient Rx LP	be81ba65-c434-4287-97d3-cd11d6031636	2025-09-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204901 application number: ANDA204901
Losartan Potassium and Hydrochlorothiazide	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	Preferred Pharmaceuticals Inc.	46cf633d-70a5-4d3b-b349-ad74c23ddace	2025-08-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204901 application number: ANDA204901
Losartan Potassium and Hydrochlorothiazide	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	Bryant Ranch Prepack	e0f63126-6890-48bf-9c25-444dc5974ecd	2025-02-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204901 application number: ANDA204901
Losartan Potassium and Hydrochlorothiazide	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	Bryant Ranch Prepack	8b36fa56-4274-4fc6-bdba-ca7a399b2b21	2025-01-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204901 application number: ANDA204901
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	Direct Rx	d8284747-07b6-9775-e053-2a95a90ad52d	2025-01-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204901 application number: ANDA204901
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	Direct Rx	d88ad738-a915-7679-e053-2a95a90a58c7	2025-01-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204901 application number: ANDA204901
Losartan Potassium and Hydrochlorothiazide	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	Quality Care Products, LLC	a6241e63-1952-4dfa-ba94-c406059501dd	2024-12-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204901 application number: ANDA204901
Losartan Potassium and Hydrochlorothiazide	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	Bryant Ranch Prepack	927315ca-211b-4976-b228-cf544f7e5259	2024-11-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204901 application number: ANDA204901
Losartan Potassium and Hydrochlorothiazide	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	A-S Medication Solutions	af44b2b0-1204-43c9-8ec1-d081d35b8f2b	2024-06-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204901 application number: ANDA204901
Losartan Potassium and Hydrochlorothiazide	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	Proficient Rx LP	c6ed6f74-0eca-4f99-8c7e-dd3f56167f01	2024-05-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204901 application number: ANDA204901
Losartan Potassium and Hydrochlorothiazide	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	A-S Medication Solutions	6bd15e74-2ca2-49c8-8c01-0a647d3fa5df	2024-01-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204901 application number: ANDA204901
Losartan Potassium and Hydrochlorothiazide	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	Bryant Ranch Prepack	42942482-1f54-4c7f-9d5f-4aaf20abb3e3	2023-11-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204901 application number: ANDA204901 ndc (product): 71335-2127

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
0J48LPH2TH	HYDROCHLOROTHIAZIDE	58-93-5	HYDROCHLOROTHIAZIDE
3ST302B24A	LOSARTAN POTASSIUM	124750-99-8	LOSARTAN POTASSIUM

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
979468	losartan potassium 50 MG / hydroCHLOROthiazide 12.5 MG Oral Tablet	PSN	42942482-1f54-4c7f-9d5f-4aaf20abb3e3	101
979468	hydrochlorothiazide 12.5 MG / losartan potassium 50 MG Oral Tablet	SCD	42942482-1f54-4c7f-9d5f-4aaf20abb3e3	101
979468	HCTZ 12.5 MG / Losartan K+ 50 MG Oral Tablet	SY	42942482-1f54-4c7f-9d5f-4aaf20abb3e3	101
979468	HCTZ 12.5 MG / Losartan Pot 50 MG Oral Tablet	SY	42942482-1f54-4c7f-9d5f-4aaf20abb3e3	101

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
71335-2127-1	71335212701	90 TABLET, FILM COATED in 1 BOTTLE (71335-2127-1)	2022-07-18	0000-00-00	No	No	Current
71335-2127-2	71335212702	60 TABLET, FILM COATED in 1 BOTTLE (71335-2127-2)	2022-07-18	0000-00-00	No	No	Current
71335-2127-3	71335212703	30 TABLET, FILM COATED in 1 BOTTLE (71335-2127-3)	2022-07-18	0000-00-00	No	No	Current
71335-2127-4	71335212704	120 TABLET, FILM COATED in 1 BOTTLE (71335-2127-4)	2022-07-18	0000-00-00	No	No	Current
71335-2127-5	71335212705	58 TABLET, FILM COATED in 1 BOTTLE (71335-2127-5)	2022-07-18	0000-00-00	No	No	Current
71335-2127-6	71335212706	100 TABLET, FILM COATED in 1 BOTTLE (71335-2127-6)	2022-07-18	0000-00-00	No	No	Current
71335-2127-7	71335212707	180 TABLET, FILM COATED in 1 BOTTLE (71335-2127-7)	2022-07-18	0000-00-00	No	No	Current
71335-2127-8	71335212708	1000 TABLET, FILM COATED in 1 BOTTLE (71335-2127-8)	2022-07-18	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Losartan Potassium and Hydrochlorothiazide	Bryant Ranch Prepack	2023-11-16	HUMAN PRESCRIPTION DRUG LABEL	101