Losartan Potassium and Hydrochlorothiazide

Product NDC: 16714-224
11-digit product format: 167140224
Labeler code: 16714
Product ID: 16714-224_d3aeeeca-2c3a-4006-89f7-e3836aa8399b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Losartan Potassium and Hydrochlorothiazide
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: NorthStar Rx LLC
Application: ANDA091629
Marketing category: ANDA
Marketing start: 2024-09-04
Substance: HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM
Active strength: 12.5; 100 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

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 4 matching rows.

View current auxiliary records. · View the auxiliary file history.

Dataset, Scope, Package NDC table
Dataset	Scope	Package NDC
excluded product	product
excluded package	package	16714-224-03
excluded package	package	16714-224-02
excluded package	package	16714-224-01

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	RLD / RS	Approval date
A091629-001	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM	12.5MG;50MG	TABLET / ORAL	AB		2010-10-06
A091629-002	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM	12.5MG;100MG	TABLET / ORAL	AB		2010-10-06
A091629-003	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM	25MG;100MG	TABLET / ORAL	AB	RS	2010-01-06

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A091629-001	AB
A091629-002	AB
A091629-003	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	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A091629-001	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	12.5MG;50MG	TABLET / ORAL	AB		2010-10-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091629-002	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	12.5MG;100MG	TABLET / ORAL	AB		2010-10-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091629-003	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	25MG;100MG	TABLET / ORAL	AB	RS	2010-01-06	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A091629-001	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	12.5MG;50MG	TABLET / ORAL	AB		2010-10-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091629-002	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	12.5MG;100MG	TABLET / ORAL	AB		2010-10-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091629-003	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	25MG;100MG	TABLET / ORAL	AB	RS	2010-01-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091629-001	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	12.5MG;50MG	TABLET / ORAL	AB		2010-10-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091629-002	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	12.5MG;100MG	TABLET / ORAL	AB		2010-10-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091629-003	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	25MG;100MG	TABLET / ORAL	AB	RS	2010-01-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091629-001	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	12.5MG;50MG	TABLET / ORAL	AB		2010-10-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091629-002	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	12.5MG;100MG	TABLET / ORAL	AB		2010-10-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091629-003	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	25MG;100MG	TABLET / ORAL	AB	RS	2010-01-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091629-001	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	12.5MG;50MG	TABLET / ORAL	AB		2010-10-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091629-002	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	12.5MG;100MG	TABLET / ORAL	AB		2010-10-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091629-003	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	25MG;100MG	TABLET / ORAL	AB	RS	2010-01-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091629-001	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	12.5MG;50MG	TABLET / ORAL	AB		2010-10-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091629-002	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	12.5MG;100MG	TABLET / ORAL	AB		2010-10-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091629-003	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	25MG;100MG	TABLET / ORAL	AB	RS	2010-01-06	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091629-001	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	12.5MG;50MG	TABLET / ORAL	AB		2010-10-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091629-002	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	12.5MG;100MG	TABLET / ORAL	AB		2010-10-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091629-003	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	25MG;100MG	TABLET / ORAL	AB	RS	2010-01-06	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091629-001	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	12.5MG;50MG	TABLET / ORAL	AB		2010-10-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091629-002	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	12.5MG;100MG	TABLET / ORAL	AB		2010-10-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091629-003	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	25MG;100MG	TABLET / ORAL	AB	RS	2010-01-06	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091629-001	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	12.5MG;50MG	TABLET / ORAL	AB		2010-10-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091629-002	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	12.5MG;100MG	TABLET / ORAL	AB		2010-10-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091629-003	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	25MG;100MG	TABLET / ORAL	AB	RS	2010-01-06	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091629-001	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	12.5MG;50MG	TABLET / ORAL	AB		2010-10-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091629-002	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	12.5MG;100MG	TABLET / ORAL	AB		2010-10-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091629-003	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	25MG;100MG	TABLET / ORAL	AB	RS	2010-01-06	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091629-001	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	12.5MG;50MG	TABLET / ORAL	AB		2010-10-06	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091629-002	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	12.5MG;100MG	TABLET / ORAL	AB		2010-10-06	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091629-003	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	25MG;100MG	TABLET / ORAL	AB	RS	2010-01-06	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091629-001	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	12.5MG;50MG	TABLET / ORAL	AB		2010-10-06	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091629-002	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	12.5MG;100MG	TABLET / ORAL	AB		2010-10-06	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091629-003	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	25MG;100MG	TABLET / ORAL	AB	RS	2010-01-06	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091629-001	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	12.5MG;50MG	TABLET / ORAL	AB		2010-10-06	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091629-002	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	12.5MG;100MG	TABLET / ORAL	AB		2010-10-06	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091629-003	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	25MG;100MG	TABLET / ORAL	AB	RS	2010-01-06	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091629-001	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	12.5MG;50MG	TABLET / ORAL	AB		2010-10-06	`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	A091629-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091629-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091629-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A091629-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091629-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091629-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091629-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091629-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091629-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091629-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091629-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091629-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091629-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091629-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091629-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091629-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091629-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091629-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091629-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091629-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091629-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091629-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091629-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091629-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091629-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091629-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091629-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091629-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091629-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091629-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091629-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091629-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091629-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091629-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091629-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091629-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091629-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091629-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091629-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091629-001	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	100 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

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

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
979464	Internal RxNorm lookup
979468	Internal RxNorm lookup
979471	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
25318baf-9c2f-458f-b9ea-f52dabca49af	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
16714-224-01	Losartan Potassium and Hydrochlorothiazide	30 in 1 BOTTLE	TABLET, FILM COATED	30	21
16714-224-02	Losartan Potassium and Hydrochlorothiazide	90 in 1 BOTTLE	TABLET, FILM COATED	90	21
16714-224-03	Losartan Potassium and Hydrochlorothiazide	1000 in 1 BOTTLE	TABLET, FILM COATED	1000	21

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
16714-224-01	EA - Each	16714-224	942ae610-0308-444f-bd10-e05f32e390d3	1	2012-07-24
16714-224-02	EA - Each	16714-224	3238642b-74fc-465a-ab66-6c91560c3e44	1	2012-07-24
16714-224-03	EA - Each	16714-224	878508b3-92af-4533-805e-d5cfb8eb1bdd	1	2024-11-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
HYDROCHLOROTHIAZIDE	ACTIVE INGREDIENT	0J48LPH2TH	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [NORTHSTAR RX LLC]	10
LOSARTAN POTASSIUM	ACTIVE INGREDIENT	3ST302B24A	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [NORTHSTAR RX LLC]	10
HYDROCHLOROTHIAZIDE	ACTIVE MOIETY	0J48LPH2TH	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [NORTHSTAR RX LLC]	10
LOSARTAN	ACTIVE MOIETY	JMS50MPO89	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [NORTHSTAR RX LLC]	10
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [NORTHSTAR RX LLC]	10
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [NORTHSTAR RX LLC]	10
HYDROXYPROPYL CELLULOSE (TYPE H)	INACTIVE INGREDIENT	RFW2ET671P	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [NORTHSTAR RX LLC]	10
HYPROMELLOSE 2910 (6 MPA.S)	INACTIVE INGREDIENT	0WZ8WG20P6	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [NORTHSTAR RX LLC]	10
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [NORTHSTAR RX LLC]	10
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [NORTHSTAR RX LLC]	10
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [NORTHSTAR RX LLC]	10
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [NORTHSTAR RX LLC]	10
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [NORTHSTAR RX LLC]	10
HYDROCHLOROTHIAZIDE	ACTIVE INGREDIENT	0J48LPH2TH	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]	1
LOSARTAN POTASSIUM	ACTIVE INGREDIENT	3ST302B24A	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]	1
HYDROCHLOROTHIAZIDE	ACTIVE MOIETY	0J48LPH2TH	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]	1
LOSARTAN	ACTIVE MOIETY	JMS50MPO89	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]	1
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]	1
HYDROXYPROPYL CELLULOSE	INACTIVE INGREDIENT	RFW2ET671P	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]	1
HYPROMELLOSE 2910 (6 MPA.S)	INACTIVE INGREDIENT	0WZ8WG20P6	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
16714-224	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [NORTHSTAR RX LLC]	20	Current NDC, Legacy NDC, 3 package rows	20240906_25318baf-9c2f-458f-b9ea-f52dabca49af.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 · 16 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.	9f9cd7a7-be95-4ea8-8247-eb7ecbd36936	2026-07-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091629 application number: ANDA091629
Losartan Potassium and Hydrochlorothiazide	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	A-S Medication Solutions	be99cc03-ea65-4b17-bd9e-df7ae4307778	2026-04-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091629 application number: ANDA091629
Losartan Potassium and Hydrochlorothiazide	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	A-S Medication Solutions	dc9512cf-db66-40e9-afcb-1d6a722772e8	2026-02-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091629 application number: ANDA091629
Losartan Potassium and Hydrochlorothiazide	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	A-S Medication Solutions	5ec290f4-bf21-4c5b-a576-8eb2bd6bd379	2026-02-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091629 application number: ANDA091629
Losartan Potassium and Hydrochlorothiazide	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	Coupler LLC	44fd38d2-cb8b-d0e8-e063-6294a90a994e	2026-01-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091629 application number: ANDA091629
Losartan Potassium and Hydrochlorothiazide	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	A-S Medication Solutions	bc8b9ae2-8263-4624-8629-4f856392f9da	2025-12-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091629 application number: ANDA091629
Losartan Potassium and Hydrochlorothiazide	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	PD-Rx Pharmaceuticals, Inc.	dcb39c6b-430d-4b3d-ba6f-5bf1efe116aa	2025-09-25	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091629 application number: ANDA091629
Losartan Potassium and Hydrochlorothiazide	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	Bryant Ranch Prepack	60f3f17d-fd28-406d-97ca-9f01f5f1c72c	2025-09-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091629 application number: ANDA091629
Losartan Potassium and Hydrochlorothiazide	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	NorthStar Rx LLC	25318baf-9c2f-458f-b9ea-f52dabca49af	2025-09-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091629 application number: ANDA091629 ndc (product): 16714-224
Losartan Potassium and Hydrochlorothiazide	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	Aurobindo Pharma Limited	dc177d6c-c754-4379-8c2f-1cf6f52f950a	2025-08-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091629 application number: ANDA091629
Losartan Potassium and Hydrochlorothiazide	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	Preferred Pharmaceuticals Inc.	24ee299f-4466-45d4-9013-17791e1998bb	2025-08-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091629 application number: ANDA091629
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	DirectRx	cf4278a3-fbb7-a8ab-e053-2a95a90abc0f	2025-01-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091629 application number: ANDA091629
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	Direct_Rx	8de04bf2-83dd-c494-e053-2a95a90abade	2025-01-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091629 application number: ANDA091629
Losartan Potassium and Hydrochlorothiazide	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	A-S Medication Solutions	98b97680-474c-4e70-89dd-15bb49773125	2024-08-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091629 application number: ANDA091629
Losartan Potassium and Hydrochlorothiazide	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	Proficient Rx LP	a6e7d8a7-f969-4a21-ac28-93c77ed1fa63	2021-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091629 application number: ANDA091629
Losartan Potassium and Hydrochlorothiazide	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	Proficient Rx LP	198d5151-7982-4639-9fe1-6573a4529348	2021-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091629 application number: ANDA091629

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
979464	losartan potassium 100 MG / hydroCHLOROthiazide 12.5 MG Oral Tablet	PSN	25318baf-9c2f-458f-b9ea-f52dabca49af	21
979471	losartan potassium 100 MG / hydroCHLOROthiazide 25 MG Oral Tablet	PSN	25318baf-9c2f-458f-b9ea-f52dabca49af	21
979468	losartan potassium 50 MG / hydroCHLOROthiazide 12.5 MG Oral Tablet	PSN	25318baf-9c2f-458f-b9ea-f52dabca49af	21
979464	hydrochlorothiazide 12.5 MG / losartan potassium 100 MG Oral Tablet	SCD	25318baf-9c2f-458f-b9ea-f52dabca49af	21
979468	hydrochlorothiazide 12.5 MG / losartan potassium 50 MG Oral Tablet	SCD	25318baf-9c2f-458f-b9ea-f52dabca49af	21
979471	hydrochlorothiazide 25 MG / losartan potassium 100 MG Oral Tablet	SCD	25318baf-9c2f-458f-b9ea-f52dabca49af	21
979464	HCTZ 12.5 MG / Losartan K+ 100 MG Oral Tablet	SY	25318baf-9c2f-458f-b9ea-f52dabca49af	21
979468	HCTZ 12.5 MG / Losartan K+ 50 MG Oral Tablet	SY	25318baf-9c2f-458f-b9ea-f52dabca49af	21
979464	HCTZ 12.5 MG / Losartan Pot 100 MG Oral Tablet	SY	25318baf-9c2f-458f-b9ea-f52dabca49af	21
979468	HCTZ 12.5 MG / Losartan Pot 50 MG Oral Tablet	SY	25318baf-9c2f-458f-b9ea-f52dabca49af	21
979464	HCTZ 12.5 MG / losartan potassium 100 MG Oral Tablet	SY	25318baf-9c2f-458f-b9ea-f52dabca49af	21
979471	HCTZ 25 MG / Losartan K+ 100 MG Oral Tablet	SY	25318baf-9c2f-458f-b9ea-f52dabca49af	21
979471	HCTZ 25 MG / Losartan Pot 100 MG Oral Tablet	SY	25318baf-9c2f-458f-b9ea-f52dabca49af	21
979471	HCTZ 25 MG / losartan potassium 100 MG Oral Tablet	SY	25318baf-9c2f-458f-b9ea-f52dabca49af	21
979464	losartan potassium 100 MG / hydroCHLOROthiazide 12.5 MG Oral Tablet	PSN	cedd3d4f-5902-4159-bde3-4cf33d098999	3
979464	hydrochlorothiazide 12.5 MG / losartan potassium 100 MG Oral Tablet	SCD	cedd3d4f-5902-4159-bde3-4cf33d098999	3
979464	HCTZ 12.5 MG / Losartan K+ 100 MG Oral Tablet	SY	cedd3d4f-5902-4159-bde3-4cf33d098999	3
979464	HCTZ 12.5 MG / Losartan Pot 100 MG Oral Tablet	SY	cedd3d4f-5902-4159-bde3-4cf33d098999	3
979464	HCTZ 12.5 MG / losartan potassium 100 MG Oral Tablet	SY	cedd3d4f-5902-4159-bde3-4cf33d098999	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
16714-224-01	16714022401	30 TABLET, FILM COATED in 1 BOTTLE (16714-224-01)	2024-09-04	2022-07-31	No	No	Current
16714-224-02	16714022402	90 TABLET, FILM COATED in 1 BOTTLE (16714-224-02)	2024-09-04	2022-07-31	No	No	Current
16714-224-03	16714022403	1000 TABLET, FILM COATED in 1 BOTTLE (16714-224-03)	2024-09-04	2022-07-31	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Losartan Potassium and Hydrochlorothiazide	NorthStar Rx LLC \| Aurobindo Pharma Limited \| APL HEALTHCARE LIMITED	2025-09-06	Human Prescription Drug Label	21
Losartan Potassium and Hydrochlorothiazide	A-S Medication Solutions	2021-04-16	Human Prescription Drug Label	3
Losartan Potassium and Hydrochlorothiazide	McKesson Corporation dba SKY Packaging \| McKesson Corporation dba RX Pak	2019-09-10	Human Prescription Drug Label	6