Losartan Potassium

Product NDC: 60760-645
11-digit product format: 607600645
Labeler code: 60760
Product ID: 60760-645_e6735480-2f09-43d8-e053-2995a90a09f2
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Losartan potassium
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: ST. MARY'S MEDICAL PARK PHARMACY
Application: ANDA091497
Marketing category: ANDA
Marketing start: 2022-07-28
Marketing end: 0000-00-00
Substance: LOSARTAN POTASSIUM
Active strength: 50 mg/1
Pharmacologic classes: Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]
NDC exclude flag: No
Listing certified through: 2023-12-31
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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	60760-645		D	Discontinued by firm	2026-08-10
excluded package	package	60760-645	60760-645-30	D	Discontinued by firm	2026-08-10
excluded package	package	60760-645	60760-645-90	D	Discontinued by firm	2026-08-10

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…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
60760-645-30	EA - Each	60760-645	dee58785-b4d7-40af-8673-e25494b2f1cb	1	2022-09-12
60760-645-90	EA - Each	60760-645	3cf01aa7-53b1-4a92-be32-fa4062885103	1	2022-10-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
60760-645	LOSARTAN POTASSIUM TABLET, FILM COATED [ST. MARY'S MEDICAL PARK PHARMACY]	2	Legacy NDC	20220819_e55d5a9c-46b5-c407-e053-2a95a90a6e28.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
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
60760-645-30	60760064530	30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (60760-645-30)	2022-08-01	0000-00-00	No	No	Current
60760-645-90	60760064590	90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (60760-645-90)	2022-08-11	0000-00-00	No	No	Current