Losartan Potassium

Product NDC: 43547-360
11-digit product format: 435470360
Labeler code: 43547
Product ID: 43547-360_098aef71-90f1-40ee-b574-03dcbbad51a4
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Losartan Potassium
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Solco Healthcare US, LLC
Application: ANDA091497
Marketing category: ANDA
Marketing start: 2022-03-20
Substance: LOSARTAN POTASSIUM
Active strength: 25 mg/1
Pharmacologic classes: Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]
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 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	Approval date
A091497-001	LOSARTAN POTASSIUM	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	AB	2011-06-06
A091497-002	LOSARTAN POTASSIUM	LOSARTAN POTASSIUM	50MG	TABLET / ORAL	AB	2011-06-06
A091497-003	LOSARTAN POTASSIUM	LOSARTAN POTASSIUM	100MG	TABLET / ORAL	AB	2011-06-06

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A091497-001	AB
A091497-002	AB
A091497-003	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	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A091497-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	AB	2011-06-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091497-002	LOSARTAN POTASSIUM	50MG	TABLET / ORAL	AB	2011-06-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091497-003	LOSARTAN POTASSIUM	100MG	TABLET / ORAL	AB	2011-06-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091497-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	AB	2011-06-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091497-002	LOSARTAN POTASSIUM	50MG	TABLET / ORAL	AB	2011-06-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091497-003	LOSARTAN POTASSIUM	100MG	TABLET / ORAL	AB	2011-06-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091497-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	AB	2011-06-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091497-002	LOSARTAN POTASSIUM	50MG	TABLET / ORAL	AB	2011-06-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091497-003	LOSARTAN POTASSIUM	100MG	TABLET / ORAL	AB	2011-06-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091497-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	AB	2011-06-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091497-002	LOSARTAN POTASSIUM	50MG	TABLET / ORAL	AB	2011-06-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091497-003	LOSARTAN POTASSIUM	100MG	TABLET / ORAL	AB	2011-06-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091497-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	AB	2011-06-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091497-002	LOSARTAN POTASSIUM	50MG	TABLET / ORAL	AB	2011-06-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091497-003	LOSARTAN POTASSIUM	100MG	TABLET / ORAL	AB	2011-06-06	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091497-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	AB	2011-06-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091497-002	LOSARTAN POTASSIUM	50MG	TABLET / ORAL	AB	2011-06-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091497-003	LOSARTAN POTASSIUM	100MG	TABLET / ORAL	AB	2011-06-06	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091497-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	AB	2011-06-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091497-002	LOSARTAN POTASSIUM	50MG	TABLET / ORAL	AB	2011-06-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091497-003	LOSARTAN POTASSIUM	100MG	TABLET / ORAL	AB	2011-06-06	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091497-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	AB	2011-06-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091497-002	LOSARTAN POTASSIUM	50MG	TABLET / ORAL	AB	2011-06-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091497-003	LOSARTAN POTASSIUM	100MG	TABLET / ORAL	AB	2011-06-06	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091497-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	AB	2011-06-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091497-002	LOSARTAN POTASSIUM	50MG	TABLET / ORAL	AB	2011-06-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091497-003	LOSARTAN POTASSIUM	100MG	TABLET / ORAL	AB	2011-06-06	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091497-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	AB	2011-06-06	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091497-002	LOSARTAN POTASSIUM	50MG	TABLET / ORAL	AB	2011-06-06	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091497-003	LOSARTAN POTASSIUM	100MG	TABLET / ORAL	AB	2011-06-06	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091497-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	AB	2011-06-06	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091497-002	LOSARTAN POTASSIUM	50MG	TABLET / ORAL	AB	2011-06-06	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091497-003	LOSARTAN POTASSIUM	100MG	TABLET / ORAL	AB	2011-06-06	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091497-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	AB	2011-06-06	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091497-002	LOSARTAN POTASSIUM	50MG	TABLET / ORAL	AB	2011-06-06	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091497-003	LOSARTAN POTASSIUM	100MG	TABLET / ORAL	AB	2011-06-06	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091497-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	AB	2011-06-06	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091497-002	LOSARTAN POTASSIUM	50MG	TABLET / ORAL	AB	2011-06-06	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091497-003	LOSARTAN POTASSIUM	100MG	TABLET / ORAL	AB	2011-06-06	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091497-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	AB	2011-06-06	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 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	A091497-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091497-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091497-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091497-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091497-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091497-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091497-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091497-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091497-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091497-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091497-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091497-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091497-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091497-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091497-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091497-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091497-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091497-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091497-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091497-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091497-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091497-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091497-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091497-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091497-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091497-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091497-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091497-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091497-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091497-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091497-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091497-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091497-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091497-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091497-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091497-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091497-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091497-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091497-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091497-001	AB	1	`8072bd15b7f6…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
LOSARTAN POTASSIUM	25 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
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
979480	Internal RxNorm lookup
979485	Internal RxNorm lookup
979492	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
fa0cf2c2-6238-4edd-94e2-b670b98a0da4	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
0d341e63-aee5-498b-bf9a-b53a43963acf	Product name	1	20260105
de29c5c0-90ba-29da-d7ab-0500274708be	Product name	6	20241009
15b375b1-89c7-9594-80df-5a8c8864aee0	Product name	3	20180108

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
43547-360-09	2020-04-23	These highlights do not include all the information needed to use LOSARTAN POTASSIUM TABLETS safely and effectively. See full prescribing information for LOSARTAN POTASSIUM TABLETS. LOSARTAN POTASSIUM tablets, for oral use Initial U.S. Approval: 1995
43547-360-11	2020-04-23	These highlights do not include all the information needed to use LOSARTAN POTASSIUM TABLETS safely and effectively. See full prescribing information for LOSARTAN POTASSIUM TABLETS. LOSARTAN POTASSIUM tablets, for oral use Initial U.S. Approval: 1995
43547-360-50	2020-04-23	These highlights do not include all the information needed to use LOSARTAN POTASSIUM TABLETS safely and effectively. See full prescribing information for LOSARTAN POTASSIUM TABLETS. LOSARTAN POTASSIUM tablets, for oral use Initial U.S. Approval: 1995
43547-360-09	2020-01-31	These highlights do not include all the information needed to use LOSARTAN POTASSIUM TABLETS safely and effectively. See full prescribing information for LOSARTAN POTASSIUM TABLETS. LOSARTAN POTASSIUM tablets, for oral use Initial U.S. Approval: 1995
43547-360-11	2020-01-31	These highlights do not include all the information needed to use LOSARTAN POTASSIUM TABLETS safely and effectively. See full prescribing information for LOSARTAN POTASSIUM TABLETS. LOSARTAN POTASSIUM tablets, for oral use Initial U.S. Approval: 1995
43547-360-50	2020-01-31	These highlights do not include all the information needed to use LOSARTAN POTASSIUM TABLETS safely and effectively. See full prescribing information for LOSARTAN POTASSIUM TABLETS. LOSARTAN POTASSIUM tablets, for oral use Initial U.S. Approval: 1995

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
43547-360-09	Losartan Potassium	90 in 1 BOTTLE	TABLET, FILM COATED	90	18
43547-360-11	Losartan Potassium	1000 in 1 BOTTLE	TABLET, FILM COATED	1000	18
43547-360-50	Losartan Potassium	500 in 1 BOTTLE	TABLET, FILM COATED	500	18

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
43547-360-09	EA - Each	43547-360	072d0326-4667-4ca8-af87-a3a7a01fdb27	1	2015-06-09
43547-360-11	EA - Each	43547-360	9e7ac41b-47f7-4448-a7b2-be11ce6fbb74	1	2022-02-07
43547-360-50	EA - Each	43547-360	3f9245fa-2632-4ffa-9a5c-a70ddaebac99	1	2015-06-09

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
LOSARTAN POTASSIUM	ACTIVE INGREDIENT	3ST302B24A	LOSARTAN POTASSIUM TABLET, FILM COATED LOSARTAN POTASSIUM TABLET, FILM COATED [SOLCO HEALTHCARE US, LLC]	9
LOSARTAN	ACTIVE MOIETY	JMS50MPO89	LOSARTAN POTASSIUM TABLET, FILM COATED LOSARTAN POTASSIUM TABLET, FILM COATED [SOLCO HEALTHCARE US, LLC]	9
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	LOSARTAN POTASSIUM TABLET, FILM COATED LOSARTAN POTASSIUM TABLET, FILM COATED [SOLCO HEALTHCARE US, LLC]	9
HYDROXYPROPYL CELLULOSE (TYPE H)	INACTIVE INGREDIENT	RFW2ET671P	LOSARTAN POTASSIUM TABLET, FILM COATED LOSARTAN POTASSIUM TABLET, FILM COATED [SOLCO HEALTHCARE US, LLC]	9
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	LOSARTAN POTASSIUM TABLET, FILM COATED LOSARTAN POTASSIUM TABLET, FILM COATED [SOLCO HEALTHCARE US, LLC]	9
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	LOSARTAN POTASSIUM TABLET, FILM COATED LOSARTAN POTASSIUM TABLET, FILM COATED [SOLCO HEALTHCARE US, LLC]	9
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	LOSARTAN POTASSIUM TABLET, FILM COATED LOSARTAN POTASSIUM TABLET, FILM COATED [SOLCO HEALTHCARE US, LLC]	9
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	LOSARTAN POTASSIUM TABLET, FILM COATED LOSARTAN POTASSIUM TABLET, FILM COATED [SOLCO HEALTHCARE US, LLC]	9
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	LOSARTAN POTASSIUM TABLET, FILM COATED LOSARTAN POTASSIUM TABLET, FILM COATED [SOLCO HEALTHCARE US, LLC]	9

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
43547-360	LOSARTAN POTASSIUM TABLET, FILM COATED LOSARTAN POTASSIUM TABLET, FILM COATED [SOLCO HEALTHCARE US, LLC]	16	Current NDC, Legacy NDC, 3 package rows	20240817_fa0cf2c2-6238-4edd-94e2-b670b98a0da4.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 · 18 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Losartan Potassium	LOSARTAN POTASSIUM	Unit Dose Solutions, Inc.	5529733c-1e3b-e590-e063-6294a90a765c	2026-06-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091497 application number: ANDA091497
Losartan Potassium	LOSARTAN POTASSIUM	Coupler LLC	53456224-db79-e7c1-e063-6394a90a90d5	2026-06-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091497 application number: ANDA091497
Losartan Potassium	LOSARTAN POTASSIUM	Preferred Pharmaceuticals Inc.	c4b81f90-bcd0-45d0-99ce-35ca998d473a	2026-06-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091497 application number: ANDA091497
Losartan Potassium	LOSARTAN POTASSIUM	REMEDYREPACK INC.	e136356b-e4d2-4e00-a409-35825c5637c9	2026-02-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091497 application number: ANDA091497
Losartan Potassium	LOSARTAN POTASSIUM	Solco Healthcare US, LLC	fa0cf2c2-6238-4edd-94e2-b670b98a0da4	2025-08-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091497 application number: ANDA091497 ndc (product): 43547-360
Losartan Potassium	LOSARTAN POTASSIUM	Preferred Pharmaceuticals Inc.	94eb89aa-296f-4e8f-a077-30a1be01ad52	2025-08-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091497 application number: ANDA091497
Losartan Potassium	LOSARTAN POTASSIUM	Preferred Pharmaceuticals Inc.	68ed9727-987e-4bb6-98b4-b98150bb6404	2025-08-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091497 application number: ANDA091497
Losartan Potassium	LOSARTAN POTASSIUM	NuCare Pharmaceuticals.Inc.	351d3c5c-05c6-921a-e063-6394a90abef9	2025-05-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091497 application number: ANDA091497
LOSARTAN POTASSIUM	LOSARTAN POTASSIUM	DIRECT RX	a58c56b2-e05c-6697-e053-2a95a90ad466	2025-01-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091497 application number: ANDA091497
Losartan Potassium	LOSARTAN POTASSIUM	NuCare Pharmaceuticals,Inc.	de5c0c87-e90b-fc14-e053-2a95a90af0c5	2024-12-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091497 application number: ANDA091497
Losartan Potassium	LOSARTAN POTASSIUM	Bryant Ranch Prepack	43fa4762-cc0c-4a3b-a527-6aa7fb7c5464	2024-08-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091497 application number: ANDA091497
Losartan Potassium	LOSARTAN POTASSIUM	Bryant Ranch Prepack	de987691-f659-45ab-9c53-402ef7421f4b	2024-08-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091497 application number: ANDA091497
Losartan Potassium	LOSARTAN POTASSIUM	Proficient Rx LP	4b298291-4251-4af8-a436-58a3443a7978	2024-08-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091497 application number: ANDA091497
Losartan Potassium	LOSARTAN POTASSIUM	NuCare Pharmaceuticals,iNc.	54b363c4-00bb-08db-e054-00144ff8d46c	2024-07-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091497 application number: ANDA091497
Losartan Potassium	LOSARTAN POTASSIUM	Proficient Rx LP	c0319153-3e35-4a84-aa63-935b1e0047d8	2022-07-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091497 application number: ANDA091497
Losartan Potassium	LOSARTAN POTASSIUM	Proficient Rx LP	1b3c03e8-da8e-4c25-a493-118e760a003b	2022-07-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091497 application number: ANDA091497
Losartan Potassium	LOSARTAN POTASSIUM	Aphena Pharma Solutions - Tennessee, LLC	35e3472a-457f-4f95-a78d-dbff2595171d	2019-01-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091497 application number: ANDA091497
Losartan Potassium	LOSARTAN POTASSIUM	Aphena Pharma Solutions - Tennessee, LLC	1f55aaa2-5848-47e0-bba0-6a70b2fa05dd	2018-12-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091497 application number: ANDA091497

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
979480	losartan potassium 100 MG Oral Tablet	PSN	fa0cf2c2-6238-4edd-94e2-b670b98a0da4	18
979485	losartan potassium 25 MG Oral Tablet	PSN	fa0cf2c2-6238-4edd-94e2-b670b98a0da4	18
979492	losartan potassium 50 MG Oral Tablet	PSN	fa0cf2c2-6238-4edd-94e2-b670b98a0da4	18
979480	losartan potassium 100 MG Oral Tablet	SCD	fa0cf2c2-6238-4edd-94e2-b670b98a0da4	18
979485	losartan potassium 25 MG Oral Tablet	SCD	fa0cf2c2-6238-4edd-94e2-b670b98a0da4	18
979492	losartan potassium 50 MG Oral Tablet	SCD	fa0cf2c2-6238-4edd-94e2-b670b98a0da4	18
979480	Losartan K+ 100 MG Oral Tablet	SY	fa0cf2c2-6238-4edd-94e2-b670b98a0da4	18
979485	Losartan K+ 25 MG Oral Tablet	SY	fa0cf2c2-6238-4edd-94e2-b670b98a0da4	18
979492	Losartan K+ 50 MG Oral Tablet	SY	fa0cf2c2-6238-4edd-94e2-b670b98a0da4	18
979480	Losartan Pot 100 MG Oral Tablet	SY	fa0cf2c2-6238-4edd-94e2-b670b98a0da4	18
979485	Losartan Pot 25 MG Oral Tablet	SY	fa0cf2c2-6238-4edd-94e2-b670b98a0da4	18
979492	Losartan Pot 50 MG Oral Tablet	SY	fa0cf2c2-6238-4edd-94e2-b670b98a0da4	18
979480	losartan potassium 100 MG Oral Tablet	PSN	eea53209-8c3e-430a-8366-e17d5da559e5	9
979485	losartan potassium 25 MG Oral Tablet	PSN	eea53209-8c3e-430a-8366-e17d5da559e5	9
979492	losartan potassium 50 MG Oral Tablet	PSN	eea53209-8c3e-430a-8366-e17d5da559e5	9
979480	losartan potassium 100 MG Oral Tablet	SCD	eea53209-8c3e-430a-8366-e17d5da559e5	9
979485	losartan potassium 25 MG Oral Tablet	SCD	eea53209-8c3e-430a-8366-e17d5da559e5	9
979492	losartan potassium 50 MG Oral Tablet	SCD	eea53209-8c3e-430a-8366-e17d5da559e5	9
979480	Losartan K+ 100 MG Oral Tablet	SY	eea53209-8c3e-430a-8366-e17d5da559e5	9
979485	Losartan K+ 25 MG Oral Tablet	SY	eea53209-8c3e-430a-8366-e17d5da559e5	9
979492	Losartan K+ 50 MG Oral Tablet	SY	eea53209-8c3e-430a-8366-e17d5da559e5	9
979480	Losartan Pot 100 MG Oral Tablet	SY	eea53209-8c3e-430a-8366-e17d5da559e5	9
979485	Losartan Pot 25 MG Oral Tablet	SY	eea53209-8c3e-430a-8366-e17d5da559e5	9
979492	Losartan Pot 50 MG Oral Tablet	SY	eea53209-8c3e-430a-8366-e17d5da559e5	9
979485	losartan potassium 25 MG Oral Tablet	PSN	e136356b-e4d2-4e00-a409-35825c5637c9	6
979485	losartan potassium 25 MG Oral Tablet	SCD	e136356b-e4d2-4e00-a409-35825c5637c9	6
979485	Losartan K+ 25 MG Oral Tablet	SY	e136356b-e4d2-4e00-a409-35825c5637c9	6
979485	Losartan Pot 25 MG Oral Tablet	SY	e136356b-e4d2-4e00-a409-35825c5637c9	6
979485	losartan potassium 25 MG Oral Tablet	PSN	a58c56b2-e05c-6697-e053-2a95a90ad466	5
979485	losartan potassium 25 MG Oral Tablet	PSN	05bcfa6f-01ff-43aa-b9bc-2ddb1b21c172	5
979485	losartan potassium 25 MG Oral Tablet	SCD	a58c56b2-e05c-6697-e053-2a95a90ad466	5
979485	losartan potassium 25 MG Oral Tablet	SCD	05bcfa6f-01ff-43aa-b9bc-2ddb1b21c172	5
979485	Losartan K+ 25 MG Oral Tablet	SY	05bcfa6f-01ff-43aa-b9bc-2ddb1b21c172	5
979485	Losartan K+ 25 MG Oral Tablet	SY	a58c56b2-e05c-6697-e053-2a95a90ad466	5
979485	Losartan Pot 25 MG Oral Tablet	SY	05bcfa6f-01ff-43aa-b9bc-2ddb1b21c172	5
979485	Losartan Pot 25 MG Oral Tablet	SY	a58c56b2-e05c-6697-e053-2a95a90ad466	5
979485	losartan potassium 25 MG Oral Tablet	PSN	1b3c03e8-da8e-4c25-a493-118e760a003b	3
979485	losartan potassium 25 MG Oral Tablet	SCD	1b3c03e8-da8e-4c25-a493-118e760a003b	3
979485	Losartan K+ 25 MG Oral Tablet	SY	1b3c03e8-da8e-4c25-a493-118e760a003b	3
979485	Losartan Pot 25 MG Oral Tablet	SY	1b3c03e8-da8e-4c25-a493-118e760a003b	3
979485	losartan potassium 25 MG Oral Tablet	PSN	35e3472a-457f-4f95-a78d-dbff2595171d	1
979485	losartan potassium 25 MG Oral Tablet	PSN	11543d8d-acf2-4ad1-bef7-d0855d1eba68	1
979485	losartan potassium 25 MG Oral Tablet	PSN	94eb89aa-296f-4e8f-a077-30a1be01ad52	1
979485	losartan potassium 25 MG Oral Tablet	SCD	35e3472a-457f-4f95-a78d-dbff2595171d	1
979485	losartan potassium 25 MG Oral Tablet	SCD	11543d8d-acf2-4ad1-bef7-d0855d1eba68	1
979485	losartan potassium 25 MG Oral Tablet	SCD	94eb89aa-296f-4e8f-a077-30a1be01ad52	1
979485	Losartan K+ 25 MG Oral Tablet	SY	35e3472a-457f-4f95-a78d-dbff2595171d	1
979485	Losartan K+ 25 MG Oral Tablet	SY	11543d8d-acf2-4ad1-bef7-d0855d1eba68	1
979485	Losartan K+ 25 MG Oral Tablet	SY	94eb89aa-296f-4e8f-a077-30a1be01ad52	1
979485	Losartan Pot 25 MG Oral Tablet	SY	35e3472a-457f-4f95-a78d-dbff2595171d	1
979485	Losartan Pot 25 MG Oral Tablet	SY	94eb89aa-296f-4e8f-a077-30a1be01ad52	1
979485	Losartan Pot 25 MG Oral Tablet	SY	11543d8d-acf2-4ad1-bef7-d0855d1eba68	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
43547-360-09	43547036009	90 TABLET, FILM COATED in 1 BOTTLE (43547-360-09)	2022-03-20	0000-00-00	No	No	Current
43547-360-11	43547036011	1000 TABLET, FILM COATED in 1 BOTTLE (43547-360-11)	2022-03-20	0000-00-00	No	No	Current
43547-360-50	43547036050	500 TABLET, FILM COATED in 1 BOTTLE (43547-360-50)	2022-03-20	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Losartan Potassium	Unit Dose Solutions, Inc.	2026-06-26	HUMAN PRESCRIPTION DRUG LABEL	1
Losartan Potassium	Coupler LLC	2026-06-02	HUMAN PRESCRIPTION DRUG LABEL	1
Losartan Potassium	REMEDYREPACK INC.	2026-02-16	HUMAN PRESCRIPTION DRUG LABEL	6
Losartan Potassium	Solco Healthcare US, LLC	2025-08-22	HUMAN PRESCRIPTION DRUG LABEL	18
Losartan Potassium	Preferred Pharmaceuticals Inc.	2025-08-08	HUMAN PRESCRIPTION DRUG LABEL	1
LOSARTAN POTASSIUM	DIRECT RX	2025-01-17	HUMAN PRESCRIPTION DRUG LABEL	5
Losartan Potassium	RPK Pharmaceuticals, Inc.	2023-06-07	HUMAN PRESCRIPTION DRUG LABEL	9
Losartan Potassium	Proficient Rx LP	2022-07-01	HUMAN PRESCRIPTION DRUG LABEL	3
Losartan Potassium	A-S Medication Solutions	2021-04-16	HUMAN PRESCRIPTION DRUG LABEL	5
Losartan Potassium	NuCare Pharmaceuticals,Inc.	2021-02-16	HUMAN PRESCRIPTION DRUG LABEL	2
Losartan Potassium	Denton Pharma, Inc. dba Northwind Pharmaceuticals	2020-04-02	HUMAN PRESCRIPTION DRUG LABEL	1
Losartan Potassium	Preferred Pharmaceuticals Inc.	2020-02-28	HUMAN PRESCRIPTION DRUG LABEL	1
Losartan Potassium	Aphena Pharma Solutions - Tennessee, LLC	2019-01-21	Human Prescription Drug Label	1
Losartan Potassium	Aidarex Pharmaceuticals LLC \| Aidarex Pharmaceuticals	2018-08-21	HUMAN PRESCRIPTION DRUG LABEL	1
LOSARTAN POTASSIUM TABLETS, USP, for oral use	NuCare Pharmaceuticals, Inc.	2017-02-17	HUMAN PRESCRIPTION DRUG LABEL	1