Losartan Potassium

Product NDC: 0054-0123
11-digit product format: 000540123
Labeler code: 0054
Product ID: 0054-0123_856bc6e8-6f23-48cd-a2b7-d222c3f99913
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Losartan Potassium
Dosage form: TABLET
Route: ORAL
Labeler: Hikma Pharmaceuticals USA Inc.
Application: ANDA077459
Marketing category: ANDA
Marketing start: 2020-07-13
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: 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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	0054-0123		D	Discontinued by firm		2026-08-17
excluded package	package	0054-0123	0054-0123-22	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 · 24 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0054-0123-22	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0054-0123-22	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0054-0123-22	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0054-0123-22	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0054-0123-22	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0054-0123-22	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0054-0123-22	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0054-0123-22	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0054-0123-22	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0054-0123-22	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0054-0123-22	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0054-0123-22	`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	Approval date
A077459-001	LOSARTAN POTASSIUM	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	2010-10-06
A077459-002	LOSARTAN POTASSIUM	LOSARTAN POTASSIUM	50MG	TABLET / ORAL	2010-10-06
A077459-003	LOSARTAN POTASSIUM	LOSARTAN POTASSIUM	100MG	TABLET / ORAL	2010-10-06

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	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A077459-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	2010-10-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077459-002	LOSARTAN POTASSIUM	50MG	TABLET / ORAL	2010-10-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077459-003	LOSARTAN POTASSIUM	100MG	TABLET / ORAL	2010-10-06	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077459-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	2010-10-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077459-002	LOSARTAN POTASSIUM	50MG	TABLET / ORAL	2010-10-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077459-003	LOSARTAN POTASSIUM	100MG	TABLET / ORAL	2010-10-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077459-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	2010-10-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077459-002	LOSARTAN POTASSIUM	50MG	TABLET / ORAL	2010-10-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077459-003	LOSARTAN POTASSIUM	100MG	TABLET / ORAL	2010-10-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077459-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	2010-10-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077459-002	LOSARTAN POTASSIUM	50MG	TABLET / ORAL	2010-10-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077459-003	LOSARTAN POTASSIUM	100MG	TABLET / ORAL	2010-10-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077459-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	2010-10-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077459-002	LOSARTAN POTASSIUM	50MG	TABLET / ORAL	2010-10-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077459-003	LOSARTAN POTASSIUM	100MG	TABLET / ORAL	2010-10-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077459-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	2010-10-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077459-002	LOSARTAN POTASSIUM	50MG	TABLET / ORAL	2010-10-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077459-003	LOSARTAN POTASSIUM	100MG	TABLET / ORAL	2010-10-06	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077459-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	2010-10-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077459-002	LOSARTAN POTASSIUM	50MG	TABLET / ORAL	2010-10-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077459-003	LOSARTAN POTASSIUM	100MG	TABLET / ORAL	2010-10-06	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077459-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	2010-10-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077459-002	LOSARTAN POTASSIUM	50MG	TABLET / ORAL	2010-10-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077459-003	LOSARTAN POTASSIUM	100MG	TABLET / ORAL	2010-10-06	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077459-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	2010-10-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077459-002	LOSARTAN POTASSIUM	50MG	TABLET / ORAL	2010-10-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077459-003	LOSARTAN POTASSIUM	100MG	TABLET / ORAL	2010-10-06	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077459-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	2010-10-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077459-002	LOSARTAN POTASSIUM	50MG	TABLET / ORAL	2010-10-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077459-003	LOSARTAN POTASSIUM	100MG	TABLET / ORAL	2010-10-06	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077459-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	2010-10-06	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077459-002	LOSARTAN POTASSIUM	50MG	TABLET / ORAL	2010-10-06	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077459-003	LOSARTAN POTASSIUM	100MG	TABLET / ORAL	2010-10-06	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077459-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	2010-10-06	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077459-002	LOSARTAN POTASSIUM	50MG	TABLET / ORAL	2010-10-06	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077459-003	LOSARTAN POTASSIUM	100MG	TABLET / ORAL	2010-10-06	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077459-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	2010-10-06	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077459-002	LOSARTAN POTASSIUM	50MG	TABLET / ORAL	2010-10-06	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077459-003	LOSARTAN POTASSIUM	100MG	TABLET / ORAL	2010-10-06	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077459-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	2010-10-06	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077459-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077459-002	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077459-003	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077459-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A077459-002	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A077459-003	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077459-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A077459-002	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A077459-003	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077459-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A077459-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A077459-003	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077459-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A077459-002	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A077459-003	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077459-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A077459-002	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A077459-003	AB	1	`782e0a99824c…`
2019-12-14 00:12 UTC	2019-12	A077459-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A077459-002	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A077459-003	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A077459-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A077459-002	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A077459-003	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A077459-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A077459-002	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A077459-003	AB	1	`ea99ee380514…`
2022-10-28 04:53 UTC	2022-10	A077459-002	AB	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A077459-003	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A077459-002	AB	1	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	A077459-003	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A077459-001	AB	1	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A077459-002	AB	1	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A077459-003	AB	1	`cb3db0bc1861…`

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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0054-0123-22	EA - Each	0054-0123	b22e0843-95a3-42b5-bbc6-eaeb628aaabe	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
LOSARTAN POTASSIUM	ACTIVE INGREDIENT	3ST302B24A	LOSARTAN POTASSIUM TABLET [ROXANE LABORATORIES, INC.]	7
LOSARTAN	ACTIVE MOIETY	JMS50MPO89	LOSARTAN POTASSIUM TABLET [ROXANE LABORATORIES, INC.]	7
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	LOSARTAN POTASSIUM TABLET [ROXANE LABORATORIES, INC.]	7
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	LOSARTAN POTASSIUM TABLET [ROXANE LABORATORIES, INC.]	7
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	LOSARTAN POTASSIUM TABLET [ROXANE LABORATORIES, INC.]	7
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	LOSARTAN POTASSIUM TABLET [ROXANE LABORATORIES, INC.]	7
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	LOSARTAN POTASSIUM TABLET [ROXANE LABORATORIES, INC.]	7
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	LOSARTAN POTASSIUM TABLET [ROXANE LABORATORIES, INC.]	7
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	LOSARTAN POTASSIUM TABLET [ROXANE LABORATORIES, INC.]	7
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	LOSARTAN POTASSIUM TABLET [ROXANE LABORATORIES, INC.]	7
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	LOSARTAN POTASSIUM TABLET [ROXANE LABORATORIES, INC.]	7
TRIACETIN	INACTIVE INGREDIENT	XHX3C3X673	LOSARTAN POTASSIUM TABLET [ROXANE LABORATORIES, INC.]	7

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
979485	losartan potassium 25 MG Oral Tablet	PSN	a5179fa4-0b29-4bf0-af0b-660c2ca52199	100
979485	losartan potassium 25 MG Oral Tablet	SCD	a5179fa4-0b29-4bf0-af0b-660c2ca52199	100
979485	Losartan K+ 25 MG Oral Tablet	SY	a5179fa4-0b29-4bf0-af0b-660c2ca52199	100
979485	Losartan Pot 25 MG Oral Tablet	SY	a5179fa4-0b29-4bf0-af0b-660c2ca52199	100

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0054-0123-22	00054012322	90 TABLET in 1 BOTTLE (0054-0123-22)	90 tablet	2010-10-06	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Losartan Potassium	Bryant Ranch Prepack	2022-05-04	HUMAN PRESCRIPTION DRUG LABEL	100
Losartan Potassium	Hikma Pharmaceuticals USA Inc. \| West-Ward Columbus Inc.	2021-10-20	HUMAN PRESCRIPTION DRUG LABEL	12
Losartan Potassium	NuCare Pharmaceuticals,Inc.	2021-02-22	HUMAN PRESCRIPTION DRUG LABEL	2