Losartan Potassium

Product NDC: 55154-2333
11-digit product format: 551542333
Labeler code: 55154
Product ID: 55154-2333_d8dff652-2d31-46fc-b6e2-793418308bab
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Losartan Potassium
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Cardinal Health 107, LLC
Application: ANDA078243
Marketing category: ANDA
Marketing start: 2010-10-04
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: 2027-12-31
Current FDA listing: Yes

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
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 · 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	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…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078243-002	LOSARTAN POTASSIUM	50MG	TABLET / ORAL	AB	2010-10-06	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078243-003	LOSARTAN POTASSIUM	100MG	TABLET / ORAL	AB	2010-10-06	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078243-001	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	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…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078243-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078243-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078243-001	AB	1	`1e350fbaab3a…`

Additional Listing Data#

Finished product: Yes
Brand name base: Losartan Potassium
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
LOSARTAN POTASSIUM	100 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
b83d896a-c7e9-4508-814c-425b88a87b16	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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
55154-2333-0	Losartan Potassium	1 in 1 BLISTER PACK	TABLET, FILM COATED	1		12
55154-2333-0	Losartan Potassium	10 in 1 BAG	TABLET, FILM COATED	10		12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
55154-2333	LOSARTAN POTASSIUM TABLET, FILM COATED [CARDINAL HEALTH 107, LLC]	10	Current NDC, Legacy NDC, 2 package rows	20250524_b83d896a-c7e9-4508-814c-425b88a87b16.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 · 13 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
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 ndc (product): 55154-2333
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	Cardinal Health 107, LLC	021cd76a-b093-4704-8410-5e7d01e20a54	2025-10-22	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
Losartan Potassium	LOSARTAN POTASSIUM	NCS HealthCare of KY, LLC dba Vangard Labs	c565e7ba-97aa-4a65-80e6-543e9af6e1c4	2025-01-03	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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
979480	losartan potassium 100 MG Oral Tablet	PSN	b83d896a-c7e9-4508-814c-425b88a87b16	12
979485	losartan potassium 25 MG Oral Tablet	PSN	b83d896a-c7e9-4508-814c-425b88a87b16	12
979492	losartan potassium 50 MG Oral Tablet	PSN	b83d896a-c7e9-4508-814c-425b88a87b16	12
979480	losartan potassium 100 MG Oral Tablet	SCD	b83d896a-c7e9-4508-814c-425b88a87b16	12
979485	losartan potassium 25 MG Oral Tablet	SCD	b83d896a-c7e9-4508-814c-425b88a87b16	12
979492	losartan potassium 50 MG Oral Tablet	SCD	b83d896a-c7e9-4508-814c-425b88a87b16	12
979480	Losartan K+ 100 MG Oral Tablet	SY	b83d896a-c7e9-4508-814c-425b88a87b16	12
979485	Losartan K+ 25 MG Oral Tablet	SY	b83d896a-c7e9-4508-814c-425b88a87b16	12
979492	Losartan K+ 50 MG Oral Tablet	SY	b83d896a-c7e9-4508-814c-425b88a87b16	12
979480	Losartan Pot 100 MG Oral Tablet	SY	b83d896a-c7e9-4508-814c-425b88a87b16	12
979485	Losartan Pot 25 MG Oral Tablet	SY	b83d896a-c7e9-4508-814c-425b88a87b16	12
979492	Losartan Pot 50 MG Oral Tablet	SY	b83d896a-c7e9-4508-814c-425b88a87b16	12

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
55154-2333-0	55154233300	10 BLISTER PACK in 1 BAG (55154-2333-0) / 1 TABLET, FILM COATED in 1 BLISTER PACK	10 blister pack	2010-10-04	0000-00-00	No	No	Current