Losortan Potassium

Product NDC: 68788-7736
Requested package NDC: 68788-7736-5
11-digit product format: 687887736
Labeler code: 68788
Product ID: 68788-7736_3dedda31-fae5-43c0-97fa-5392d2d8f21d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Losartan Potassium
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Preferred Pharmaceuticals, Inc.
Application: ANDA078243
Marketing category: ANDA
Marketing start: 2020-07-01
Marketing end: 0000-00-00
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: 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	68788-7736	68788-7736-5	D	Discontinued by firm		2026-10-05

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 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	TE codes	Approval date
A078243-001	LOSARTAN POTASSIUM	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	AB	2010-10-06
A078243-002	LOSARTAN POTASSIUM	LOSARTAN POTASSIUM	50MG	TABLET / ORAL	AB	2010-10-06
A078243-003	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
A078243-001	AB
A078243-002	AB
A078243-003	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 · 129 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
2026-09-14 22:38:34	2026-08	A078243-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	AB	2010-10-06	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078243-002	LOSARTAN POTASSIUM	50MG	TABLET / ORAL	AB	2010-10-06	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078243-003	LOSARTAN POTASSIUM	100MG	TABLET / ORAL	AB	2010-10-06	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A078243-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	AB	2010-10-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078243-002	LOSARTAN POTASSIUM	50MG	TABLET / ORAL	AB	2010-10-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078243-003	LOSARTAN POTASSIUM	100MG	TABLET / ORAL	AB	2010-10-06	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078243-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	AB	2010-10-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078243-002	LOSARTAN POTASSIUM	50MG	TABLET / ORAL	AB	2010-10-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078243-003	LOSARTAN POTASSIUM	100MG	TABLET / ORAL	AB	2010-10-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078243-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	AB	2010-10-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078243-002	LOSARTAN POTASSIUM	50MG	TABLET / ORAL	AB	2010-10-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078243-003	LOSARTAN POTASSIUM	100MG	TABLET / ORAL	AB	2010-10-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078243-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	AB	2010-10-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078243-002	LOSARTAN POTASSIUM	50MG	TABLET / ORAL	AB	2010-10-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078243-003	LOSARTAN POTASSIUM	100MG	TABLET / ORAL	AB	2010-10-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078243-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	AB	2010-10-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078243-002	LOSARTAN POTASSIUM	50MG	TABLET / ORAL	AB	2010-10-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078243-003	LOSARTAN POTASSIUM	100MG	TABLET / ORAL	AB	2010-10-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078243-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	AB	2010-10-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078243-002	LOSARTAN POTASSIUM	50MG	TABLET / ORAL	AB	2010-10-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078243-003	LOSARTAN POTASSIUM	100MG	TABLET / ORAL	AB	2010-10-06	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078243-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	AB	2010-10-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078243-002	LOSARTAN POTASSIUM	50MG	TABLET / ORAL	AB	2010-10-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078243-003	LOSARTAN POTASSIUM	100MG	TABLET / ORAL	AB	2010-10-06	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078243-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	AB	2010-10-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078243-002	LOSARTAN POTASSIUM	50MG	TABLET / ORAL	AB	2010-10-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078243-003	LOSARTAN POTASSIUM	100MG	TABLET / ORAL	AB	2010-10-06	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078243-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	AB	2010-10-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078243-002	LOSARTAN POTASSIUM	50MG	TABLET / ORAL	AB	2010-10-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078243-003	LOSARTAN POTASSIUM	100MG	TABLET / ORAL	AB	2010-10-06	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078243-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	AB	2010-10-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078243-002	LOSARTAN POTASSIUM	50MG	TABLET / ORAL	AB	2010-10-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078243-003	LOSARTAN POTASSIUM	100MG	TABLET / ORAL	AB	2010-10-06	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078243-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	AB	2010-10-06	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078243-002	LOSARTAN POTASSIUM	50MG	TABLET / ORAL	AB	2010-10-06	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078243-003	LOSARTAN POTASSIUM	100MG	TABLET / ORAL	AB	2010-10-06	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078243-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	AB	2010-10-06	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078243-002	LOSARTAN POTASSIUM	50MG	TABLET / ORAL	AB	2010-10-06	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078243-003	LOSARTAN POTASSIUM	100MG	TABLET / ORAL	AB	2010-10-06	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078243-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	AB	2010-10-06	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A078243-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078243-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078243-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A078243-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078243-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078243-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078243-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078243-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078243-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078243-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078243-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078243-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078243-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078243-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078243-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078243-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078243-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078243-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078243-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078243-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078243-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078243-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078243-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078243-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078243-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078243-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078243-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078243-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078243-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078243-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078243-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078243-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078243-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078243-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078243-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078243-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078243-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078243-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078243-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078243-001	AB	1	`301d65b070ca…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68788-7736-1	EA - Each	68788-7736	38150283-9d1a-407d-97a1-4849f1c6a871	1	2020-09-14
68788-7736-3	EA - Each	68788-7736	5646eebc-4c32-40a8-bc87-2b811b26d363	1	2020-09-14
68788-7736-5	EA - Each	68788-7736	f7b90aa2-25ee-4989-8bdb-009e5df13600	1	2020-09-14
68788-7736-6	EA - Each	68788-7736	881570a5-01cb-4e80-8824-9e2701b33f5e	1	2020-09-14
68788-7736-9	EA - Each	68788-7736	a5e5ad97-d846-4e26-979c-39a8f1bcdadd	1	2020-09-14

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 · 12 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Losartan Potassium	LOSARTAN POTASSIUM	Cardinal Health 107, LLC	021cd76a-b093-4704-8410-5e7d01e20a54	2026-08-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078243 application number: ANDA078243
Losartan Potassium	LOSARTAN POTASSIUM	Major Pharmaceuticals	c15387df-87a4-4784-acb5-7dd550498f8f	2026-07-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078243 application number: ANDA078243
Losartan Potassium	LOSARTAN POTASSIUM	Zydus Pharmaceuticals USA Inc.	3233c707-70b6-4c29-8210-913eeb2a38ed	2026-07-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078243 application number: ANDA078243
Losartan Potassium	LOSARTAN POTASSIUM	American Health Packaging	e7f6b25b-ec4c-4c3a-a541-617d2d9ab393	2026-06-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078243 application number: ANDA078243
Losartan Potassium	LOSARTAN POTASSIUM	Cardinal Health 107, LLC	b83d896a-c7e9-4508-814c-425b88a87b16	2026-06-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078243 application number: ANDA078243
Losortan Potassium	LOSARTAN POTASSIUM	Preferred Pharmaceuticals Inc.	25651749-8950-43ff-bcbd-3bb85f57a360	2026-05-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078243 application number: ANDA078243
Losortan Potassium	LOSARTAN POTASSIUM	Bryant Ranch Prepack	1b285c10-f468-4d87-b36d-79047f686c58	2026-05-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078243 application number: ANDA078243
Losartan Potassium	LOSARTAN POTASSIUM	Zydus Lifesciences Limited	9ccd6823-e813-472c-99cd-c6ef25e74bed	2026-01-12		Exact identifier application applno (ANDA): 078243 application number: ANDA078243
Losartan Potassium	LOSARTAN POTASSIUM	Quallent Pharmaceuticals Health LLC	1a9e1ffd-edf1-4e35-a7f5-ca351c507d7f	2026-01-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078243 application number: ANDA078243
Losortan Potassium	LOSARTAN POTASSIUM	AvPAK	a6cd0b5f-2bd6-bed9-e053-2995a90a3191	2026-01-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078243 application number: ANDA078243
LOSARTAN POTASSIUM	LOSARTAN POTASSIUM	DIRECT RX	a58c56b2-e05c-6697-e053-2a95a90ad466	2025-01-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078243 application number: ANDA078243
Losortan Potassium	LOSARTAN POTASSIUM	Proficient Rx LP	364fe10e-11ca-4ee6-9f67-c85dec09aca5	2019-11-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078243 application number: ANDA078243

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
68788-7736-5	68788773605	50 TABLET, FILM COATED in 1 BOTTLE (68788-7736-5)	2020-07-01	0000-00-00	No	No	Current