Losartan Potassium

Product NDC: 45865-687
11-digit product format: 458650687
Labeler code: 45865
Product ID: 45865-687_7d789f3b-68f1-33c7-e053-2991aa0a0330
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Losartan Potassium
Dosage form: TABLET
Route: ORAL
Labeler: medsource pharmaceuticals
Application: ANDA090467
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: 2020-12-31
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	45865-687		I	Inactivated by FDA	2026-08-03
excluded package	package	45865-687	45865-687-30	I	Inactivated by FDA	2026-08-03
excluded package	package	45865-687	45865-687-49	I	Inactivated by FDA	2026-08-03

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 · 27 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	45865-687-49	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	45865-687-30	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	45865-687-49	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	45865-687-30	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	45865-687-49	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	45865-687-30	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	45865-687-49	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	45865-687-30	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	45865-687-49	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	45865-687-30	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	45865-687-49	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	45865-687-30	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	45865-687-30	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	45865-687-49	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	45865-687-30	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	45865-687-49	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	45865-687-30	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	45865-687-49	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	Approval date
A090467-001	LOSARTAN POTASSIUM	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	2010-10-06
A090467-002	LOSARTAN POTASSIUM	LOSARTAN POTASSIUM	50MG	TABLET / ORAL	2010-10-06
A090467-003	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 · 123 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A090467-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	2010-10-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090467-002	LOSARTAN POTASSIUM	50MG	TABLET / ORAL	2010-10-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090467-003	LOSARTAN POTASSIUM	100MG	TABLET / ORAL	2010-10-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090467-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	2010-10-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090467-002	LOSARTAN POTASSIUM	50MG	TABLET / ORAL	2010-10-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090467-003	LOSARTAN POTASSIUM	100MG	TABLET / ORAL	2010-10-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090467-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	2010-10-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090467-002	LOSARTAN POTASSIUM	50MG	TABLET / ORAL	2010-10-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090467-003	LOSARTAN POTASSIUM	100MG	TABLET / ORAL	2010-10-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090467-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	2010-10-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090467-002	LOSARTAN POTASSIUM	50MG	TABLET / ORAL	2010-10-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090467-003	LOSARTAN POTASSIUM	100MG	TABLET / ORAL	2010-10-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090467-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	2010-10-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090467-002	LOSARTAN POTASSIUM	50MG	TABLET / ORAL	2010-10-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090467-003	LOSARTAN POTASSIUM	100MG	TABLET / ORAL	2010-10-06	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090467-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	2010-10-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090467-002	LOSARTAN POTASSIUM	50MG	TABLET / ORAL	2010-10-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090467-003	LOSARTAN POTASSIUM	100MG	TABLET / ORAL	2010-10-06	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090467-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	2010-10-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090467-002	LOSARTAN POTASSIUM	50MG	TABLET / ORAL	2010-10-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090467-003	LOSARTAN POTASSIUM	100MG	TABLET / ORAL	2010-10-06	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090467-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	2010-10-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090467-002	LOSARTAN POTASSIUM	50MG	TABLET / ORAL	2010-10-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090467-003	LOSARTAN POTASSIUM	100MG	TABLET / ORAL	2010-10-06	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090467-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	2010-10-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090467-002	LOSARTAN POTASSIUM	50MG	TABLET / ORAL	2010-10-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090467-003	LOSARTAN POTASSIUM	100MG	TABLET / ORAL	2010-10-06	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090467-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	2010-10-06	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090467-002	LOSARTAN POTASSIUM	50MG	TABLET / ORAL	2010-10-06	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090467-003	LOSARTAN POTASSIUM	100MG	TABLET / ORAL	2010-10-06	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090467-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	2010-10-06	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090467-002	LOSARTAN POTASSIUM	50MG	TABLET / ORAL	2010-10-06	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090467-003	LOSARTAN POTASSIUM	100MG	TABLET / ORAL	2010-10-06	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090467-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	2010-10-06	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090467-002	LOSARTAN POTASSIUM	50MG	TABLET / ORAL	2010-10-06	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090467-003	LOSARTAN POTASSIUM	100MG	TABLET / ORAL	2010-10-06	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090467-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	2010-10-06	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090467-002	LOSARTAN POTASSIUM	50MG	TABLET / ORAL	2010-10-06	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090467-003	LOSARTAN POTASSIUM	100MG	TABLET / ORAL	2010-10-06	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090467-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	2010-10-06	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A090467-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A090467-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A090467-003	AB	1	`74a2ff9319b5…`
2020-12-22 03:56 UTC	2020-12	A090467-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A090467-002	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A090467-003	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A090467-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A090467-002	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A090467-003	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A090467-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A090467-002	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A090467-003	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A090467-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A090467-002	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A090467-003	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A090467-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A090467-002	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A090467-003	AB	1	`ea99ee380514…`

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, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
45865-687-30	2025-01-30	C162847	48780-1	2cef2736-a3f3-d83d-e063-dadaa90ab31f	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 Rx Only Initial U.S. Approval: 1995
45865-687-49	2025-01-30	C162847	48780-1	2cef2736-a3f3-d83d-e063-dadaa90ab31f	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 Rx Only Initial U.S. Approval: 1995

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
45865-687-30	Losartan Potassium	30 in 1 BOTTLE	TABLET	30		2
45865-687-49	Losartan Potassium	100 in 1 CARTON	TABLET	100		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
45865-687	LOSARTAN POTASSIUM TABLET [MEDSOURCE PHARMACEUTICALS]	2	Legacy NDC, 2 package rows	20181221_7d789f2c-8d42-9ec5-e053-2a91aa0a3355.zip

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	7d789f2c-8d42-9ec5-e053-2a91aa0a3355	2
979485	losartan potassium 25 MG Oral Tablet	SCD	7d789f2c-8d42-9ec5-e053-2a91aa0a3355	2
979485	Losartan K+ 25 MG Oral Tablet	SY	7d789f2c-8d42-9ec5-e053-2a91aa0a3355	2
979485	Losartan Pot 25 MG Oral Tablet	SY	7d789f2c-8d42-9ec5-e053-2a91aa0a3355	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
45865-687-30	45865068730	30 TABLET in 1 BOTTLE (45865-687-30)	30 tablet	2018-06-01	0000-00-00	No	No	Current
45865-687-49	45865068749	100 TABLET in 1 CARTON (45865-687-49)	100 tablet	2018-06-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Losartan Potassium	medsource pharmaceuticals \| Torrent Pharma, Inc.	2018-12-20	HUMAN PRESCRIPTION DRUG LABEL	2