Losartan Potassium

Product NDC: 68788-4160
11-digit product format: 687884160
Labeler code: 68788
Product ID: 68788-4160_9501dfaa-c8cf-46d6-8bec-936c4fd8fe03
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Losartan
Dosage form: TABLET
Route: ORAL
Labeler: Preferred Pharmaceuticals Inc.
Application: ANDA215959
Marketing category: ANDA
Marketing start: 2026-07-16
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: 2027-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A215959-001	LOSARTAN POTASSIUM	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	AB	2023-02-23
A215959-002	LOSARTAN POTASSIUM	LOSARTAN POTASSIUM	50MG	TABLET / ORAL	AB	2023-02-23
A215959-003	LOSARTAN POTASSIUM	LOSARTAN POTASSIUM	100MG	TABLET / ORAL	AB	2023-02-23

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A215959-001	AB
A215959-002	AB
A215959-003	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 2 · 75 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
2026-09-14 22:38:34	2026-08	A215959-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	AB	2023-02-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A215959-002	LOSARTAN POTASSIUM	50MG	TABLET / ORAL	AB	2023-02-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A215959-003	LOSARTAN POTASSIUM	100MG	TABLET / ORAL	AB	2023-02-23	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A215959-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	AB	2023-02-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A215959-002	LOSARTAN POTASSIUM	50MG	TABLET / ORAL	AB	2023-02-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A215959-003	LOSARTAN POTASSIUM	100MG	TABLET / ORAL	AB	2023-02-23	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A215959-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	AB	2023-02-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215959-002	LOSARTAN POTASSIUM	50MG	TABLET / ORAL	AB	2023-02-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215959-003	LOSARTAN POTASSIUM	100MG	TABLET / ORAL	AB	2023-02-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215959-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	AB	2023-02-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215959-002	LOSARTAN POTASSIUM	50MG	TABLET / ORAL	AB	2023-02-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215959-003	LOSARTAN POTASSIUM	100MG	TABLET / ORAL	AB	2023-02-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A215959-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	AB	2023-02-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215959-002	LOSARTAN POTASSIUM	50MG	TABLET / ORAL	AB	2023-02-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215959-003	LOSARTAN POTASSIUM	100MG	TABLET / ORAL	AB	2023-02-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215959-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	AB	2023-02-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215959-002	LOSARTAN POTASSIUM	50MG	TABLET / ORAL	AB	2023-02-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215959-003	LOSARTAN POTASSIUM	100MG	TABLET / ORAL	AB	2023-02-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215959-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	AB	2023-02-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215959-002	LOSARTAN POTASSIUM	50MG	TABLET / ORAL	AB	2023-02-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215959-003	LOSARTAN POTASSIUM	100MG	TABLET / ORAL	AB	2023-02-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215959-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	AB	2023-02-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215959-002	LOSARTAN POTASSIUM	50MG	TABLET / ORAL	AB	2023-02-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215959-003	LOSARTAN POTASSIUM	100MG	TABLET / ORAL	AB	2023-02-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215959-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	AB	2023-02-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215959-002	LOSARTAN POTASSIUM	50MG	TABLET / ORAL	AB	2023-02-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215959-003	LOSARTAN POTASSIUM	100MG	TABLET / ORAL	AB	2023-02-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215959-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	AB	2023-02-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215959-002	LOSARTAN POTASSIUM	50MG	TABLET / ORAL	AB	2023-02-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215959-003	LOSARTAN POTASSIUM	100MG	TABLET / ORAL	AB	2023-02-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215959-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	AB	2023-02-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215959-002	LOSARTAN POTASSIUM	50MG	TABLET / ORAL	AB	2023-02-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215959-003	LOSARTAN POTASSIUM	100MG	TABLET / ORAL	AB	2023-02-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A215959-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	AB	2023-02-23	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A215959-002	LOSARTAN POTASSIUM	50MG	TABLET / ORAL	AB	2023-02-23	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A215959-003	LOSARTAN POTASSIUM	100MG	TABLET / ORAL	AB	2023-02-23	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215959-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	AB	2023-02-23	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215959-002	LOSARTAN POTASSIUM	50MG	TABLET / ORAL	AB	2023-02-23	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215959-003	LOSARTAN POTASSIUM	100MG	TABLET / ORAL	AB	2023-02-23	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215959-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	AB	2023-02-23	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 75 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A215959-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A215959-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A215959-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A215959-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A215959-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A215959-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A215959-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215959-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215959-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215959-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215959-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215959-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A215959-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215959-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215959-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215959-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215959-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215959-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215959-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215959-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215959-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215959-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215959-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215959-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215959-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215959-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215959-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215959-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215959-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215959-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215959-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215959-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215959-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A215959-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A215959-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A215959-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215959-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215959-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215959-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215959-001	AB	1	`301d65b070ca…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product: Yes
Brand name base: Losartan Potassium
Listing expiration: 2027-12-31

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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
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
9501dfaa-c8cf-46d6-8bec-936c4fd8fe03	Available on FDA.report

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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Losartan Potassium	LOSARTAN	Preferred Pharmaceuticals Inc.	9501dfaa-c8cf-46d6-8bec-936c4fd8fe03	2026-07-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215959 application number: ANDA215959 ndc (product): 68788-4160
Losartan Potassium	LOSARTAN	Granules Pharmaceuticals Inc.	ca012edc-923d-4ada-a261-db82b71b3c4f	2025-12-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215959 application number: ANDA215959
Losartan Potassium	LOSARTAN	Granules India Ltd	f9953f51-f30a-952d-e053-6394a90abf5f	2025-07-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215959 application number: ANDA215959

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
3ST302B24A	LOSARTAN POTASSIUM	124750-99-8	LOSARTAN POTASSIUM
JMS50MPO89	LOSARTAN	114798-26-4	Losartan

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
68788-4160-3	68788416003	30 TABLET in 1 BOTTLE (68788-4160-3)	30 tablet	2026-07-16	No	No	Current
68788-4160-9	68788416009	90 TABLET in 1 BOTTLE (68788-4160-9)	90 tablet	2026-07-16	No	No	Current