Losartan Potassium

Product NDC: 53002-5624
11-digit product format: 530025624
Labeler code: 53002
Product ID: 53002-5624_eaf41ac8-b7b1-44d7-a887-f82336270d25
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Losartan Potassium
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: RPK Pharmaceuticals, Inc.
Application: ANDA090083
Marketing category: ANDA
Marketing start: 2010-10-06
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 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	53002-5624		I	Inactivated by FDA	2026-08-07
excluded package	package	53002-5624	53002-5624-0	I	Inactivated by FDA	2026-08-07
excluded package	package	53002-5624	53002-5624-3	I	Inactivated by FDA	2026-08-07
excluded package	package	53002-5624	53002-5624-9	I	Inactivated by FDA	2026-08-07

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 · 36 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	53002-5624-0	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	53002-5624-9	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	53002-5624-3	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	53002-5624-0	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	53002-5624-9	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	53002-5624-3	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	53002-5624-0	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	53002-5624-9	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	53002-5624-3	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	53002-5624-0	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	53002-5624-9	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	53002-5624-3	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	53002-5624-0	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	53002-5624-9	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	53002-5624-3	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	53002-5624-0	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	53002-5624-9	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	53002-5624-3	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	53002-5624-9	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	53002-5624-0	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	53002-5624-3	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	53002-5624-9	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	53002-5624-0	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	53002-5624-3	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	53002-5624-9	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	53002-5624-0	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	53002-5624-3	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`

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
A090083-001	LOSARTAN POTASSIUM	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	AB	2010-10-06
A090083-002	LOSARTAN POTASSIUM	LOSARTAN POTASSIUM	50MG	TABLET / ORAL	AB	2010-10-06
A090083-003	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
A090083-001	AB
A090083-002	AB
A090083-003	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	A090083-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	AB	2010-10-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090083-002	LOSARTAN POTASSIUM	50MG	TABLET / ORAL	AB	2010-10-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090083-003	LOSARTAN POTASSIUM	100MG	TABLET / ORAL	AB	2010-10-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090083-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	AB	2010-10-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090083-002	LOSARTAN POTASSIUM	50MG	TABLET / ORAL	AB	2010-10-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090083-003	LOSARTAN POTASSIUM	100MG	TABLET / ORAL	AB	2010-10-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090083-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	AB	2010-10-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090083-002	LOSARTAN POTASSIUM	50MG	TABLET / ORAL	AB	2010-10-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090083-003	LOSARTAN POTASSIUM	100MG	TABLET / ORAL	AB	2010-10-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090083-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	AB	2010-10-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090083-002	LOSARTAN POTASSIUM	50MG	TABLET / ORAL	AB	2010-10-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090083-003	LOSARTAN POTASSIUM	100MG	TABLET / ORAL	AB	2010-10-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090083-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	AB	2010-10-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090083-002	LOSARTAN POTASSIUM	50MG	TABLET / ORAL	AB	2010-10-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090083-003	LOSARTAN POTASSIUM	100MG	TABLET / ORAL	AB	2010-10-06	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090083-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	AB	2010-10-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090083-002	LOSARTAN POTASSIUM	50MG	TABLET / ORAL	AB	2010-10-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090083-003	LOSARTAN POTASSIUM	100MG	TABLET / ORAL	AB	2010-10-06	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090083-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	AB	2010-10-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090083-002	LOSARTAN POTASSIUM	50MG	TABLET / ORAL	AB	2010-10-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090083-003	LOSARTAN POTASSIUM	100MG	TABLET / ORAL	AB	2010-10-06	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090083-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	AB	2010-10-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090083-002	LOSARTAN POTASSIUM	50MG	TABLET / ORAL	AB	2010-10-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090083-003	LOSARTAN POTASSIUM	100MG	TABLET / ORAL	AB	2010-10-06	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090083-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	AB	2010-10-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090083-002	LOSARTAN POTASSIUM	50MG	TABLET / ORAL	AB	2010-10-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090083-003	LOSARTAN POTASSIUM	100MG	TABLET / ORAL	AB	2010-10-06	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090083-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	AB	2010-10-06	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090083-002	LOSARTAN POTASSIUM	50MG	TABLET / ORAL	AB	2010-10-06	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090083-003	LOSARTAN POTASSIUM	100MG	TABLET / ORAL	AB	2010-10-06	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090083-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	AB	2010-10-06	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090083-002	LOSARTAN POTASSIUM	50MG	TABLET / ORAL	AB	2010-10-06	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090083-003	LOSARTAN POTASSIUM	100MG	TABLET / ORAL	AB	2010-10-06	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090083-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	AB	2010-10-06	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090083-002	LOSARTAN POTASSIUM	50MG	TABLET / ORAL	AB	2010-10-06	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090083-003	LOSARTAN POTASSIUM	100MG	TABLET / ORAL	AB	2010-10-06	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090083-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	AB	2010-10-06	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090083-002	LOSARTAN POTASSIUM	50MG	TABLET / ORAL	AB	2010-10-06	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090083-003	LOSARTAN POTASSIUM	100MG	TABLET / ORAL	AB	2010-10-06	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090083-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	AB	2010-10-06	`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	A090083-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090083-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090083-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090083-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090083-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090083-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090083-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090083-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090083-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090083-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090083-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090083-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090083-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090083-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090083-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090083-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090083-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090083-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090083-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090083-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090083-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090083-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090083-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090083-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090083-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090083-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090083-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090083-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090083-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090083-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090083-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090083-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090083-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090083-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090083-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090083-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090083-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090083-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090083-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090083-001	AB	1	`8072bd15b7f6…`

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
53002-5624-0	2025-01-30	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
53002-5624-3	2025-01-30	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
53002-5624-9	2025-01-30	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
53002-5624-0	2023-06-08	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
53002-5624-3	2023-06-08	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
53002-5624-9	2023-06-08	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
53002-5624-0	2023-01-30	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
53002-5624-3	2023-01-30	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
53002-5624-9	2023-01-30	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
53002-5624-0	Losartan Potassium	100 in 1 BOTTLE	TABLET, FILM COATED	100	8
53002-5624-3	Losartan Potassium	30 in 1 BOTTLE	TABLET, FILM COATED	30	8
53002-5624-9	Losartan Potassium	90 in 1 BOTTLE	TABLET, FILM COATED	90	8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
53002-5624	LOSARTAN POTASSIUM TABLET, FILM COATED [RPK PHARMACEUTICALS, INC.]	8	Legacy NDC, 3 package rows	20230609_8dfe73ee-7815-404b-801a-57482688271c.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 2 · 23 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Losartan Potassium	LOSARTAN POTASSIUM	REMEDYREPACK INC.	df4f55f0-fb11-4f6f-a7ed-127b50f955fc	2026-07-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090083 application number: ANDA090083
Losartan Potassium	LOSARTAN POTASSIUM	REMEDYREPACK INC.	f7cf8a7d-90f1-46a3-abff-1eb316aa7d72	2026-07-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090083 application number: ANDA090083
Losartan Potassium	LOSARTAN POTASSIUM	REMEDYREPACK INC.	25c93638-7016-47d2-a57c-e4a5245ca41b	2026-06-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090083 application number: ANDA090083
Losartan Potassium	LOSARTAN POTASSIUM	Unit Dose Solutions, Inc.	552a2f78-6318-310f-e063-6394a90abb15	2026-06-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090083 application number: ANDA090083
Losartan Potassium	LOSARTAN POTASSIUM	REMEDYREPACK INC.	41069514-0491-41fe-b7fe-a52d42d33848	2026-06-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090083 application number: ANDA090083
Losartan Potassium	LOSARTAN POTASSIUM	PD-Rx Pharmaceuticals, Inc.	f9a92771-5c73-4f17-ac38-29fabfd4a919	2026-05-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090083 application number: ANDA090083
Losartan Potassium	LOSARTAN POTASSIUM	PD-Rx Pharmaceuticals, Inc.	5f7612dc-dccf-49e2-b541-3dab9dc1f97a	2026-05-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090083 application number: ANDA090083
Losartan Potassium	LOSARTAN POTASSIUM	Northwind Health Company, LLC	d9ced981-d791-6600-e053-2995a90ace3b	2026-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090083 application number: ANDA090083
Losartan Potassium	LOSARTAN POTASSIUM	Northwind Health Company, LLC	d9de3627-9aa2-65c8-e053-2995a90ab5ec	2026-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090083 application number: ANDA090083
Losartan Potassium	LOSARTAN POTASSIUM	Northwind Health Company, LLC	d9dfae69-9ce7-0c6b-e053-2a95a90aace8	2026-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090083 application number: ANDA090083
Losartan Potassium	LOSARTAN POTASSIUM	QPharma, Inc.	2a7513c4-b73b-46fe-ba86-6e58658cdbc7	2025-12-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090083 application number: ANDA090083
Losartan Potassium	LOSARTAN POTASSIUM	QPharma, Inc.	16a6a582-eb4d-41bc-9d49-fc1d4117b29a	2025-12-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090083 application number: ANDA090083
Losartan Potassium	LOSARTAN POTASSIUM	Aurobindo Pharma Limited	31366b4b-dfd6-4fda-babe-2cb3d2c14a2b	2025-09-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090083 application number: ANDA090083
Losartan Potassium	LOSARTAN POTASSIUM	Bryant Ranch Prepack	4d7a0e82-4791-4e3f-932a-2f1a2993ba36	2025-09-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090083 application number: ANDA090083
Losartan Potassium	LOSARTAN POTASSIUM	Bryant Ranch Prepack	45d0b1cc-d88d-4044-9692-c143cdf7a1b8	2025-09-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090083 application number: ANDA090083
Losartan Potassium	LOSARTAN POTASSIUM	Bryant Ranch Prepack	0c728db3-86ae-4ed9-b86a-78ff8d18876a	2025-09-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090083 application number: ANDA090083
Losartan Potassium	LOSARTAN POTASSIUM	A-S Medication Solutions	73bb1210-fa46-4c88-b07c-14ff5580ef18	2025-08-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090083 application number: ANDA090083
Losartan Potassium	LOSARTAN POTASSIUM	NuCare Pharmaceuticals,Inc.	9130921b-02f0-82d6-e053-2995a90a9c0a	2024-06-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090083 application number: ANDA090083
Losartan Potassium	LOSARTAN POTASSIUM	NuCare Pharmaceuticals,Inc.	91305ca4-7d56-2052-e053-2995a90a5d61	2024-06-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090083 application number: ANDA090083
Losartan Potassium	LOSARTAN POTASSIUM	NuCare Pharmaceuticals,Inc.	8c2b3412-254b-8fa9-e053-2a95a90a7dc6	2024-06-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090083 application number: ANDA090083

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	8dfe73ee-7815-404b-801a-57482688271c	8
979485	losartan potassium 25 MG Oral Tablet	SCD	8dfe73ee-7815-404b-801a-57482688271c	8
979485	Losartan K+ 25 MG Oral Tablet	SY	8dfe73ee-7815-404b-801a-57482688271c	8
979485	Losartan Pot 25 MG Oral Tablet	SY	8dfe73ee-7815-404b-801a-57482688271c	8

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
53002-5624-0	53002562400	100 TABLET, FILM COATED in 1 BOTTLE (53002-5624-0)	2019-01-01	0000-00-00	No	No	Current
53002-5624-3	53002562403	30 TABLET, FILM COATED in 1 BOTTLE (53002-5624-3)	2019-01-01	0000-00-00	No	No	Current
53002-5624-9	53002562409	90 TABLET, FILM COATED in 1 BOTTLE (53002-5624-9)	2019-01-01	0000-00-00	No	No	Current