Losartan Potassium and Hydrochlorothiazide

Product NDC: 63187-398
Requested package NDC: 63187-398-30
11-digit product format: 631870398
Labeler code: 63187
Product ID: 63187-398_0d66603d-b111-4b2e-a841-c47935b8c41a
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Losartan Potassium and Hydrochlorothiazide
Dosage form: TABLET
Route: ORAL
Labeler: Proficient Rx LP
Application: ANDA090528
Marketing category: ANDA
Marketing start: 2010-10-06
Marketing end: 0000-00-00
Substance: HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM
Active strength: 13 mg/1; mg/1
Pharmacologic classes: Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [CS],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC]
NDC exclude flag: No
Listing certified through: 2022-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	63187-398	63187-398-30	D	Discontinued by firm		2026-09-14

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 · 2 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Archive	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	63187-398	63187-398-30	D	Discontinued by firm		excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	63187-398	63187-398-30	D	Discontinued by firm		excluded / ndc_excluded.zip	`f5e01cc5f278…`	`a2eaf40c39c3…`

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

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	Approval date
A090528-001	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM	12.5MG;50MG	TABLET / ORAL	2010-10-06
A090528-002	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM	25MG;100MG	TABLET / ORAL	2010-10-06
A090528-003	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM	12.5MG;100MG	TABLET / ORAL	2010-04-06

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 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A090528-001	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	12.5MG;50MG	TABLET / ORAL	2010-10-06	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090528-002	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	25MG;100MG	TABLET / ORAL	2010-10-06	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090528-003	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	12.5MG;100MG	TABLET / ORAL	2010-04-06	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A090528-001	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	12.5MG;50MG	TABLET / ORAL	2010-10-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090528-002	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	25MG;100MG	TABLET / ORAL	2010-10-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090528-003	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	12.5MG;100MG	TABLET / ORAL	2010-04-06	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090528-001	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	12.5MG;50MG	TABLET / ORAL	2010-10-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090528-002	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	25MG;100MG	TABLET / ORAL	2010-10-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090528-003	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	12.5MG;100MG	TABLET / ORAL	2010-04-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090528-001	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	12.5MG;50MG	TABLET / ORAL	2010-10-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090528-002	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	25MG;100MG	TABLET / ORAL	2010-10-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090528-003	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	12.5MG;100MG	TABLET / ORAL	2010-04-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090528-001	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	12.5MG;50MG	TABLET / ORAL	2010-10-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090528-002	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	25MG;100MG	TABLET / ORAL	2010-10-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090528-003	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	12.5MG;100MG	TABLET / ORAL	2010-04-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090528-001	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	12.5MG;50MG	TABLET / ORAL	2010-10-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090528-002	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	25MG;100MG	TABLET / ORAL	2010-10-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090528-003	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	12.5MG;100MG	TABLET / ORAL	2010-04-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090528-001	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	12.5MG;50MG	TABLET / ORAL	2010-10-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090528-002	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	25MG;100MG	TABLET / ORAL	2010-10-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090528-003	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	12.5MG;100MG	TABLET / ORAL	2010-04-06	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090528-001	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	12.5MG;50MG	TABLET / ORAL	2010-10-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090528-002	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	25MG;100MG	TABLET / ORAL	2010-10-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090528-003	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	12.5MG;100MG	TABLET / ORAL	2010-04-06	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090528-001	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	12.5MG;50MG	TABLET / ORAL	2010-10-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090528-002	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	25MG;100MG	TABLET / ORAL	2010-10-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090528-003	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	12.5MG;100MG	TABLET / ORAL	2010-04-06	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090528-001	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	12.5MG;50MG	TABLET / ORAL	2010-10-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090528-002	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	25MG;100MG	TABLET / ORAL	2010-10-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090528-003	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	12.5MG;100MG	TABLET / ORAL	2010-04-06	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090528-001	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	12.5MG;50MG	TABLET / ORAL	2010-10-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090528-002	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	25MG;100MG	TABLET / ORAL	2010-10-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090528-003	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	12.5MG;100MG	TABLET / ORAL	2010-04-06	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090528-001	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	12.5MG;50MG	TABLET / ORAL	2010-10-06	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090528-002	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	25MG;100MG	TABLET / ORAL	2010-10-06	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090528-003	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	12.5MG;100MG	TABLET / ORAL	2010-04-06	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090528-001	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	12.5MG;50MG	TABLET / ORAL	2010-10-06	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090528-002	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	25MG;100MG	TABLET / ORAL	2010-10-06	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090528-003	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	12.5MG;100MG	TABLET / ORAL	2010-04-06	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090528-001	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	12.5MG;50MG	TABLET / ORAL	2010-10-06	`301d65b070ca…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A090528-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A090528-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A090528-003	AB	1	`74a2ff9319b5…`
2021-12-28 21:50 UTC	2021-12	A090528-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A090528-002	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A090528-003	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090528-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090528-002	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090528-003	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A090528-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A090528-002	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A090528-003	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A090528-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A090528-002	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A090528-003	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A090528-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A090528-002	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A090528-003	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A090528-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A090528-002	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A090528-003	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A090528-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A090528-002	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A090528-003	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A090528-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A090528-002	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A090528-003	AB	1	`ea99ee380514…`

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
HYDROCHLOROTHIAZIDE	ACTIVE INGREDIENT	0J48LPH2TH	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLET [PROFICIENT RX LP]	2
LOSARTAN POTASSIUM	ACTIVE INGREDIENT	3ST302B24A	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLET [PROFICIENT RX LP]	2
HYDROCHLOROTHIAZIDE	ACTIVE MOIETY	0J48LPH2TH	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLET [PROFICIENT RX LP]	2
LOSARTAN	ACTIVE MOIETY	JMS50MPO89	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLET [PROFICIENT RX LP]	2
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLET [PROFICIENT RX LP]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63187-398	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLET [PROFICIENT RX LP]	4	Legacy NDC	20210115_51c30548-81c9-4b56-ade6-2e56a3fe828e.zip

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
63187-398-30	63187039830	30 TABLET in 1 BOTTLE (63187-398-30)	30 tablet	2019-01-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Losartan Potassium and Hydrochlorothiazide	Proficient Rx LP	2021-01-01	HUMAN PRESCRIPTION DRUG LABEL	4