Losartan Potassium

Product NDC: 65862-201
Requested package NDC: 65862-201-05
11-digit product format: 658620201
Labeler code: 65862
Product ID: 65862-201_1942e030-0f36-4f65-9f60-4898439afc61
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Losartan Potassium
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Aurobindo Pharma Limited
Application: ANDA090083
Marketing category: ANDA
Marketing start: 2010-10-06
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: 2026-12-31
Current FDA listing: Yes

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…`

Additional Listing Data#

Finished product: Yes
Brand name base: Losartan Potassium
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
LOSARTAN POTASSIUM	25 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
31366b4b-dfd6-4fda-babe-2cb3d2c14a2b	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	SPL version
65862-201-05	Losartan Potassium	500 in 1 BOTTLE	TABLET, FILM COATED	500	25
65862-201-30	Losartan Potassium	30 in 1 BOTTLE	TABLET, FILM COATED	30	25
65862-201-90	Losartan Potassium	90 in 1 BOTTLE	TABLET, FILM COATED	90	25
65862-201-99	Losartan Potassium	1000 in 1 BOTTLE	TABLET, FILM COATED	1000	25

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
65862-201-90	EA - Each	65862-201	29c03b91-70b4-413e-b514-6334cf383629	1	2012-07-24
65862-201-99	EA - Each	65862-201	efa5aa2d-d37e-4e73-ae5e-1d374cb9db2a	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, FILM COATED [AUROBINDO PHARMA LIMITED]	12
LOSARTAN	ACTIVE MOIETY	JMS50MPO89	LOSARTAN POTASSIUM TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	12
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	LOSARTAN POTASSIUM TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	12
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	LOSARTAN POTASSIUM TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	12
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	LOSARTAN POTASSIUM TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	12
HYDROXYPROPYL CELLULOSE	INACTIVE INGREDIENT	RFW2ET671P	LOSARTAN POTASSIUM TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	12
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED	INACTIVE INGREDIENT	2165RE0K14	LOSARTAN POTASSIUM TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	12
HYPROMELLOSE 2910 (6 MPA.S)	INACTIVE INGREDIENT	0WZ8WG20P6	LOSARTAN POTASSIUM TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	12
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	LOSARTAN POTASSIUM TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	12
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	LOSARTAN POTASSIUM TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	12
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	LOSARTAN POTASSIUM TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	12
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	LOSARTAN POTASSIUM TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	12
WATER	INACTIVE INGREDIENT	059QF0KO0R	LOSARTAN POTASSIUM TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
65862-201	LOSARTAN POTASSIUM TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	23	Current NDC, Legacy NDC, 4 package rows	20240529_31366b4b-dfd6-4fda-babe-2cb3d2c14a2b.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 ndc (package): 65862-201-05 ndc (product): 65862-201 ndc11 (package): 65862020105
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
979480	losartan potassium 100 MG Oral Tablet	PSN	73bb1210-fa46-4c88-b07c-14ff5580ef18	36
979485	losartan potassium 25 MG Oral Tablet	PSN	73bb1210-fa46-4c88-b07c-14ff5580ef18	36
979492	losartan potassium 50 MG Oral Tablet	PSN	73bb1210-fa46-4c88-b07c-14ff5580ef18	36
979480	losartan potassium 100 MG Oral Tablet	SCD	73bb1210-fa46-4c88-b07c-14ff5580ef18	36
979485	losartan potassium 25 MG Oral Tablet	SCD	73bb1210-fa46-4c88-b07c-14ff5580ef18	36
979492	losartan potassium 50 MG Oral Tablet	SCD	73bb1210-fa46-4c88-b07c-14ff5580ef18	36
979480	Losartan K+ 100 MG Oral Tablet	SY	73bb1210-fa46-4c88-b07c-14ff5580ef18	36
979485	Losartan K+ 25 MG Oral Tablet	SY	73bb1210-fa46-4c88-b07c-14ff5580ef18	36
979492	Losartan K+ 50 MG Oral Tablet	SY	73bb1210-fa46-4c88-b07c-14ff5580ef18	36
979480	Losartan Pot 100 MG Oral Tablet	SY	73bb1210-fa46-4c88-b07c-14ff5580ef18	36
979485	Losartan Pot 25 MG Oral Tablet	SY	73bb1210-fa46-4c88-b07c-14ff5580ef18	36
979492	Losartan Pot 50 MG Oral Tablet	SY	73bb1210-fa46-4c88-b07c-14ff5580ef18	36
979480	losartan potassium 100 MG Oral Tablet	PSN	31366b4b-dfd6-4fda-babe-2cb3d2c14a2b	25
979485	losartan potassium 25 MG Oral Tablet	PSN	31366b4b-dfd6-4fda-babe-2cb3d2c14a2b	25
979492	losartan potassium 50 MG Oral Tablet	PSN	31366b4b-dfd6-4fda-babe-2cb3d2c14a2b	25
979480	losartan potassium 100 MG Oral Tablet	SCD	31366b4b-dfd6-4fda-babe-2cb3d2c14a2b	25
979485	losartan potassium 25 MG Oral Tablet	SCD	31366b4b-dfd6-4fda-babe-2cb3d2c14a2b	25
979492	losartan potassium 50 MG Oral Tablet	SCD	31366b4b-dfd6-4fda-babe-2cb3d2c14a2b	25
979480	Losartan K+ 100 MG Oral Tablet	SY	31366b4b-dfd6-4fda-babe-2cb3d2c14a2b	25
979485	Losartan K+ 25 MG Oral Tablet	SY	31366b4b-dfd6-4fda-babe-2cb3d2c14a2b	25
979492	Losartan K+ 50 MG Oral Tablet	SY	31366b4b-dfd6-4fda-babe-2cb3d2c14a2b	25
979480	Losartan Pot 100 MG Oral Tablet	SY	31366b4b-dfd6-4fda-babe-2cb3d2c14a2b	25
979485	Losartan Pot 25 MG Oral Tablet	SY	31366b4b-dfd6-4fda-babe-2cb3d2c14a2b	25
979492	Losartan Pot 50 MG Oral Tablet	SY	31366b4b-dfd6-4fda-babe-2cb3d2c14a2b	25
979485	losartan potassium 25 MG Oral Tablet	PSN	f7cf8a7d-90f1-46a3-abff-1eb316aa7d72	20
979485	losartan potassium 25 MG Oral Tablet	SCD	f7cf8a7d-90f1-46a3-abff-1eb316aa7d72	20
979485	Losartan K+ 25 MG Oral Tablet	SY	f7cf8a7d-90f1-46a3-abff-1eb316aa7d72	20
979485	Losartan Pot 25 MG Oral Tablet	SY	f7cf8a7d-90f1-46a3-abff-1eb316aa7d72	20
979485	losartan potassium 25 MG Oral Tablet	PSN	45d0b1cc-d88d-4044-9692-c143cdf7a1b8	8
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 potassium 25 MG Oral Tablet	SCD	45d0b1cc-d88d-4044-9692-c143cdf7a1b8	8
979485	Losartan K+ 25 MG Oral Tablet	SY	45d0b1cc-d88d-4044-9692-c143cdf7a1b8	8
979485	Losartan K+ 25 MG Oral Tablet	SY	8dfe73ee-7815-404b-801a-57482688271c	8
979485	Losartan Pot 25 MG Oral Tablet	SY	45d0b1cc-d88d-4044-9692-c143cdf7a1b8	8
979485	Losartan Pot 25 MG Oral Tablet	SY	8dfe73ee-7815-404b-801a-57482688271c	8
979485	losartan potassium 25 MG Oral Tablet	PSN	16a6a582-eb4d-41bc-9d49-fc1d4117b29a	7
979485	losartan potassium 25 MG Oral Tablet	SCD	16a6a582-eb4d-41bc-9d49-fc1d4117b29a	7
979485	Losartan K+ 25 MG Oral Tablet	SY	16a6a582-eb4d-41bc-9d49-fc1d4117b29a	7
979485	Losartan Pot 25 MG Oral Tablet	SY	16a6a582-eb4d-41bc-9d49-fc1d4117b29a	7
979485	losartan potassium 25 MG Oral Tablet	PSN	d9dfae69-9ce7-0c6b-e053-2a95a90aace8	4
979485	losartan potassium 25 MG Oral Tablet	SCD	d9dfae69-9ce7-0c6b-e053-2a95a90aace8	4
979485	Losartan K+ 25 MG Oral Tablet	SY	d9dfae69-9ce7-0c6b-e053-2a95a90aace8	4
979485	Losartan Pot 25 MG Oral Tablet	SY	d9dfae69-9ce7-0c6b-e053-2a95a90aace8	4
979485	losartan potassium 25 MG Oral Tablet	PSN	cff0c9eb-fafd-48e7-a053-036b676bf57d	3
979485	losartan potassium 25 MG Oral Tablet	PSN	9130921b-02f0-82d6-e053-2995a90a9c0a	3
979485	losartan potassium 25 MG Oral Tablet	SCD	9130921b-02f0-82d6-e053-2995a90a9c0a	3
979485	losartan potassium 25 MG Oral Tablet	SCD	cff0c9eb-fafd-48e7-a053-036b676bf57d	3
979485	Losartan K+ 25 MG Oral Tablet	SY	cff0c9eb-fafd-48e7-a053-036b676bf57d	3
979485	Losartan K+ 25 MG Oral Tablet	SY	9130921b-02f0-82d6-e053-2995a90a9c0a	3
979485	Losartan Pot 25 MG Oral Tablet	SY	cff0c9eb-fafd-48e7-a053-036b676bf57d	3
979485	Losartan Pot 25 MG Oral Tablet	SY	9130921b-02f0-82d6-e053-2995a90a9c0a	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
65862-201-05	65862020105	500 TABLET, FILM COATED in 1 BOTTLE (65862-201-05)	2010-10-06	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Losartan Potassium	REMEDYREPACK INC.	2026-07-17	HUMAN PRESCRIPTION DRUG LABEL	21
Losartan Potassium	REMEDYREPACK INC.	2026-01-13	HUMAN PRESCRIPTION DRUG LABEL	9
Losartan Potassium	Northwind Health Company, LLC	2026-01-01	HUMAN PRESCRIPTION DRUG LABEL	4
Losartan Potassium	QPharma, Inc. \| Northwind Health Company, LLC	2025-12-15	HUMAN PRESCRIPTION DRUG LABEL	7
Losartan Potassium	Aurobindo Pharma Limited \| APL HEALTHCARE LIMITED	2025-09-30	Human Prescription Drug Label	25
Losartan Potassium	Bryant Ranch Prepack	2025-09-18	HUMAN PRESCRIPTION DRUG LABEL	8
Losartan Potassium	A-S Medication Solutions	2025-08-26	Human Prescription Drug Label	36
Losartan Potassium	NuCare Pharmaceuticals,Inc.	2024-06-19	HUMAN PRESCRIPTION DRUG LABEL	3
Losartan Potassium	A-S Medication Solutions	2023-10-24	Human Prescription Drug Label	3
Losartan Potassium	RPK Pharmaceuticals, Inc.	2023-06-07	Human Prescription Drug Label	8
Losartan Potassium	Preferred Pharmaceuticals, Inc.	2021-07-13	HUMAN PRESCRIPTION DRUG LABEL	3