LOSARTAN POTASSIUM

Product NDC: 71335-1082
Requested package NDC: 71335-1082-4
11-digit product format: 713351082
Labeler code: 71335
Product ID: 71335-1082_05b4b16f-e350-48ab-95e8-5702841a5c2f
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: LOSARTAN POTASSIUM
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: ANDA090382
Marketing category: ANDA
Marketing start: 2018-01-04
Marketing end: 0000-00-00
Substance: LOSARTAN POTASSIUM
Active strength: 100 mg/1
Pharmacologic classes: Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC]
NDC exclude flag: No
Listing certified through: 2020-12-31
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	71335-1082	71335-1082-4	D	Discontinued by firm		2026-08-17

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 · 12 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`

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
A090382-001	LOSARTAN POTASSIUM	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	AB	2010-10-06
A090382-002	LOSARTAN POTASSIUM	LOSARTAN POTASSIUM	50MG	TABLET / ORAL	AB	2010-10-06
A090382-003	LOSARTAN POTASSIUM	LOSARTAN POTASSIUM	100MG	TABLET / ORAL	AB	2010-10-06

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A090382-001	AB
A090382-002	AB
A090382-003	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	A090382-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	AB	2010-10-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090382-002	LOSARTAN POTASSIUM	50MG	TABLET / ORAL	AB	2010-10-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090382-003	LOSARTAN POTASSIUM	100MG	TABLET / ORAL	AB	2010-10-06	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090382-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	AB	2010-10-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090382-002	LOSARTAN POTASSIUM	50MG	TABLET / ORAL	AB	2010-10-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090382-003	LOSARTAN POTASSIUM	100MG	TABLET / ORAL	AB	2010-10-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090382-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	AB	2010-10-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090382-002	LOSARTAN POTASSIUM	50MG	TABLET / ORAL	AB	2010-10-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090382-003	LOSARTAN POTASSIUM	100MG	TABLET / ORAL	AB	2010-10-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090382-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	AB	2010-10-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090382-002	LOSARTAN POTASSIUM	50MG	TABLET / ORAL	AB	2010-10-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090382-003	LOSARTAN POTASSIUM	100MG	TABLET / ORAL	AB	2010-10-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090382-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	AB	2010-10-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090382-002	LOSARTAN POTASSIUM	50MG	TABLET / ORAL	AB	2010-10-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090382-003	LOSARTAN POTASSIUM	100MG	TABLET / ORAL	AB	2010-10-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090382-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	AB	2010-10-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090382-002	LOSARTAN POTASSIUM	50MG	TABLET / ORAL	AB	2010-10-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090382-003	LOSARTAN POTASSIUM	100MG	TABLET / ORAL	AB	2010-10-06	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090382-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	AB	2010-10-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090382-002	LOSARTAN POTASSIUM	50MG	TABLET / ORAL	AB	2010-10-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090382-003	LOSARTAN POTASSIUM	100MG	TABLET / ORAL	AB	2010-10-06	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090382-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	AB	2010-10-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090382-002	LOSARTAN POTASSIUM	50MG	TABLET / ORAL	AB	2010-10-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090382-003	LOSARTAN POTASSIUM	100MG	TABLET / ORAL	AB	2010-10-06	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090382-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	AB	2010-10-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090382-002	LOSARTAN POTASSIUM	50MG	TABLET / ORAL	AB	2010-10-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090382-003	LOSARTAN POTASSIUM	100MG	TABLET / ORAL	AB	2010-10-06	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090382-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	AB	2010-10-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090382-002	LOSARTAN POTASSIUM	50MG	TABLET / ORAL	AB	2010-10-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090382-003	LOSARTAN POTASSIUM	100MG	TABLET / ORAL	AB	2010-10-06	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090382-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	AB	2010-10-06	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090382-002	LOSARTAN POTASSIUM	50MG	TABLET / ORAL	AB	2010-10-06	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090382-003	LOSARTAN POTASSIUM	100MG	TABLET / ORAL	AB	2010-10-06	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090382-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	AB	2010-10-06	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090382-002	LOSARTAN POTASSIUM	50MG	TABLET / ORAL	AB	2010-10-06	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090382-003	LOSARTAN POTASSIUM	100MG	TABLET / ORAL	AB	2010-10-06	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090382-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	AB	2010-10-06	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090382-002	LOSARTAN POTASSIUM	50MG	TABLET / ORAL	AB	2010-10-06	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090382-003	LOSARTAN POTASSIUM	100MG	TABLET / ORAL	AB	2010-10-06	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090382-001	LOSARTAN POTASSIUM	25MG	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	A090382-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090382-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090382-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090382-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090382-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090382-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090382-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090382-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090382-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090382-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090382-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090382-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090382-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090382-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090382-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090382-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090382-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090382-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090382-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090382-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090382-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090382-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090382-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090382-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090382-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090382-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090382-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090382-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090382-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090382-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090382-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090382-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090382-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090382-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090382-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090382-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090382-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090382-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090382-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090382-001	AB	1	`1e350fbaab3a…`

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 · 8 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
LOSARTAN POTASSIUM 25 mg	LOSARTAN POTASSIUM	PD-Rx Pharmaceuticals, Inc.	4d60e755-40a6-4187-b09e-e55c735945aa	2026-02-25	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090382 application number: ANDA090382
LOSARTAN POTASSIUM 25 mg	LOSARTAN POTASSIUM	PD-Rx Pharmaceuticals, Inc.	372ba4ad-26ca-4675-8475-4b664fbecba9	2026-02-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090382 application number: ANDA090382
LOSARTAN POTASSIUM 50 mg	LOSARTAN POTASSIUM	PD-Rx Pharmaceuticals, Inc.	498f26a1-5030-4f9b-9599-07d50e912d41	2026-02-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090382 application number: ANDA090382
LOSARTAN POTASSIUM 25 mg	LOSARTAN POTASSIUM	Strides Pharma Science Limited	a8817f22-8478-49b9-8354-ab27ca222c6b	2026-01-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090382 application number: ANDA090382
LOSARTAN POTASSIUM 50 mg	LOSARTAN POTASSIUM	Northwind Health Company, LLC	c29d999d-adc9-6c66-e053-2995a90a1fc3	2026-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090382 application number: ANDA090382
LOSARTAN POTASSIUM 100 mg	LOSARTAN POTASSIUM	NuCare Pharmaceuticals,Inc.	a955160f-3c2d-3366-e053-2a95a90a65ea	2024-07-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090382 application number: ANDA090382
LOSARTAN POTASSIUM 25 mg	LOSARTAN POTASSIUM	Proficient Rx LP	e8075254-cdfd-44f3-a9c2-1ed913f846ea	2022-07-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090382 application number: ANDA090382
LOSARTAN POTASSIUM 50 mg	LOSARTAN POTASSIUM	Proficient Rx LP	f260f7c5-a55b-4294-ae02-2586929e24c9	2021-08-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090382 application number: ANDA090382

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
3ST302B24A	LOSARTAN POTASSIUM	124750-99-8	LOSARTAN POTASSIUM

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
71335-1082-4	71335108204	120 TABLET, FILM COATED in 1 BOTTLE (71335-1082-4)	2019-02-07	0000-00-00	No	No	Current