Losartan Potassium

Product NDC: 11788-101
11-digit product format: 117880101
Labeler code: 11788
Product ID: 11788-101_0768a3af-f3b0-406b-bedb-c4c4bf11d1d4
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Losartan Potassium
Dosage form: TABLET
Route: ORAL
Labeler: AiPing Pharmaceutical, Inc.
Application: ANDA090544
Marketing category: ANDA
Marketing start: 2025-12-15
Substance: LOSARTAN POTASSIUM
Active strength: 50 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 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
A090544-001	LOSARTAN POTASSIUM	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	AB	2010-10-06
A090544-002	LOSARTAN POTASSIUM	LOSARTAN POTASSIUM	50MG	TABLET / ORAL	AB	2010-10-06
A090544-003	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
A090544-001	AB
A090544-002	AB
A090544-003	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	A090544-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	AB	2010-10-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090544-002	LOSARTAN POTASSIUM	50MG	TABLET / ORAL	AB	2010-10-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090544-003	LOSARTAN POTASSIUM	100MG	TABLET / ORAL	AB	2010-10-06	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090544-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	AB	2010-10-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090544-002	LOSARTAN POTASSIUM	50MG	TABLET / ORAL	AB	2010-10-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090544-003	LOSARTAN POTASSIUM	100MG	TABLET / ORAL	AB	2010-10-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090544-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	AB	2010-10-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090544-002	LOSARTAN POTASSIUM	50MG	TABLET / ORAL	AB	2010-10-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090544-003	LOSARTAN POTASSIUM	100MG	TABLET / ORAL	AB	2010-10-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090544-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	AB	2010-10-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090544-002	LOSARTAN POTASSIUM	50MG	TABLET / ORAL	AB	2010-10-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090544-003	LOSARTAN POTASSIUM	100MG	TABLET / ORAL	AB	2010-10-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090544-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL		2010-10-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090544-002	LOSARTAN POTASSIUM	50MG	TABLET / ORAL		2010-10-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090544-003	LOSARTAN POTASSIUM	100MG	TABLET / ORAL		2010-10-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090544-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL		2010-10-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090544-002	LOSARTAN POTASSIUM	50MG	TABLET / ORAL		2010-10-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090544-003	LOSARTAN POTASSIUM	100MG	TABLET / ORAL		2010-10-06	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090544-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL		2010-10-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090544-002	LOSARTAN POTASSIUM	50MG	TABLET / ORAL		2010-10-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090544-003	LOSARTAN POTASSIUM	100MG	TABLET / ORAL		2010-10-06	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090544-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL		2010-10-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090544-002	LOSARTAN POTASSIUM	50MG	TABLET / ORAL		2010-10-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090544-003	LOSARTAN POTASSIUM	100MG	TABLET / ORAL		2010-10-06	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090544-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL		2010-10-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090544-002	LOSARTAN POTASSIUM	50MG	TABLET / ORAL		2010-10-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090544-003	LOSARTAN POTASSIUM	100MG	TABLET / ORAL		2010-10-06	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090544-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL		2010-10-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090544-002	LOSARTAN POTASSIUM	50MG	TABLET / ORAL		2010-10-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090544-003	LOSARTAN POTASSIUM	100MG	TABLET / ORAL		2010-10-06	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090544-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL		2010-10-06	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090544-002	LOSARTAN POTASSIUM	50MG	TABLET / ORAL		2010-10-06	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090544-003	LOSARTAN POTASSIUM	100MG	TABLET / ORAL		2010-10-06	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090544-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL		2010-10-06	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090544-002	LOSARTAN POTASSIUM	50MG	TABLET / ORAL		2010-10-06	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090544-003	LOSARTAN POTASSIUM	100MG	TABLET / ORAL		2010-10-06	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090544-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL		2010-10-06	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090544-002	LOSARTAN POTASSIUM	50MG	TABLET / ORAL		2010-10-06	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090544-003	LOSARTAN POTASSIUM	100MG	TABLET / ORAL		2010-10-06	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090544-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL		2010-10-06	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 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	A090544-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090544-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090544-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090544-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090544-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090544-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090544-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090544-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090544-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090544-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090544-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090544-003	AB	1	`6a471c1ec25d…`
2019-12-13 00:20 UTC	2019-12	A090544-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A090544-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A090544-003	AB	1	`74a2ff9319b5…`
2021-12-28 21:50 UTC	2021-12	A090544-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A090544-002	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A090544-003	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090544-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090544-002	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090544-003	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A090544-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A090544-002	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A090544-003	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A090544-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A090544-002	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A090544-003	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A090544-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A090544-002	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A090544-003	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A090544-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A090544-002	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A090544-003	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A090544-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A090544-002	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A090544-003	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A090544-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A090544-002	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A090544-003	AB	1	`ea99ee380514…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A090544-001	AB	1	`a50c72e98297…`

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	50 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
1ae817aa-5221-4387-a457-306785140741	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
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
594e2c86-3079-4e6e-96c9-48f7a8afc78d	Product name	1	20230718
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
15b375b1-89c7-9594-80df-5a8c8864aee0	Product name	3	20180108
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
11788-101-10	Losartan Potassium	1000 in 1 BOTTLE	TABLET	1000	1
11788-101-30	Losartan Potassium	30 in 1 BOTTLE	TABLET	30	1
11788-101-90	Losartan Potassium	90 in 1 BOTTLE	TABLET	90	1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
11788-101-10	EA - Each	11788-101	bf0be4b5-fcd3-42f7-8e94-00ff99b275e9	1	2026-01-08
11788-101-30	EA - Each	11788-101	ec515482-1486-47d8-8c52-79e8b06a1989	1	2026-01-08
11788-101-90	EA - Each	11788-101	42218545-11fe-435c-b507-7b691e166f81	1	2026-01-08

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Losartan Potassium	LOSARTAN POTASSIUM	AiPing Pharmaceutical, Inc.	1ae817aa-5221-4387-a457-306785140741	2025-12-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090544 application number: ANDA090544 ndc (product): 11788-101

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	1ae817aa-5221-4387-a457-306785140741	1
979485	losartan potassium 25 MG Oral Tablet	PSN	1ae817aa-5221-4387-a457-306785140741	1
979492	losartan potassium 50 MG Oral Tablet	PSN	1ae817aa-5221-4387-a457-306785140741	1
979480	losartan potassium 100 MG Oral Tablet	SCD	1ae817aa-5221-4387-a457-306785140741	1
979485	losartan potassium 25 MG Oral Tablet	SCD	1ae817aa-5221-4387-a457-306785140741	1
979492	losartan potassium 50 MG Oral Tablet	SCD	1ae817aa-5221-4387-a457-306785140741	1
979480	Losartan K+ 100 MG Oral Tablet	SY	1ae817aa-5221-4387-a457-306785140741	1
979485	Losartan K+ 25 MG Oral Tablet	SY	1ae817aa-5221-4387-a457-306785140741	1
979492	Losartan K+ 50 MG Oral Tablet	SY	1ae817aa-5221-4387-a457-306785140741	1
979480	Losartan Pot 100 MG Oral Tablet	SY	1ae817aa-5221-4387-a457-306785140741	1
979485	Losartan Pot 25 MG Oral Tablet	SY	1ae817aa-5221-4387-a457-306785140741	1
979492	Losartan Pot 50 MG Oral Tablet	SY	1ae817aa-5221-4387-a457-306785140741	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
11788-101-10	11788010110	1000 TABLET in 1 BOTTLE (11788-101-10)	1000 tablet	2025-12-15	No	No	Current
11788-101-30	11788010130	30 TABLET in 1 BOTTLE (11788-101-30)	30 tablet	2025-12-15	No	No	Current
11788-101-90	11788010190	90 TABLET in 1 BOTTLE (11788-101-90)	90 tablet	2025-12-15	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Losartan Potassium	AiPing Pharmaceutical, Inc. \| Zhejiang Jingxin Pharmaceutical Co.Ltd.	2025-12-12	HUMAN PRESCRIPTION DRUG LABEL	1