Losartan potassium Tablets, 25 mg

Product NDC: 71610-417
Requested package NDC: 71610-417-45
11-digit product format: 716100417
Labeler code: 71610
Product ID: 71610-417_81147c23-9287-4087-8ae7-53731ec9a7ec
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: losartan potassium
Dosage form: TABLET
Route: ORAL
Labeler: Aphena Pharma Solutions - Tennessee, LLC
Application: ANDA201170
Marketing category: ANDA
Marketing start: 2018-10-23
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: 2021-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	71610-417	71610-417-45	D	Discontinued by firm		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 · 2 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Archive	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	71610-417	71610-417-45	D	Discontinued by firm		excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	71610-417	71610-417-45	D	Discontinued by firm		excluded / ndc_excluded.zip	`f5e01cc5f278…`	`a2eaf40c39c3…`

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
A201170-001	LOSARTAN POTASSIUM	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	AB	2012-09-18
A201170-002	LOSARTAN POTASSIUM	LOSARTAN POTASSIUM	50MG	TABLET / ORAL	AB	2012-09-18
A201170-003	LOSARTAN POTASSIUM	LOSARTAN POTASSIUM	100MG	TABLET / ORAL	AB	2012-09-18

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A201170-001	AB
A201170-002	AB
A201170-003	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	A201170-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	AB	2012-09-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201170-002	LOSARTAN POTASSIUM	50MG	TABLET / ORAL	AB	2012-09-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201170-003	LOSARTAN POTASSIUM	100MG	TABLET / ORAL	AB	2012-09-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201170-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	AB	2012-09-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201170-002	LOSARTAN POTASSIUM	50MG	TABLET / ORAL	AB	2012-09-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201170-003	LOSARTAN POTASSIUM	100MG	TABLET / ORAL	AB	2012-09-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A201170-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	AB	2012-09-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201170-002	LOSARTAN POTASSIUM	50MG	TABLET / ORAL	AB	2012-09-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201170-003	LOSARTAN POTASSIUM	100MG	TABLET / ORAL	AB	2012-09-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201170-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	AB	2012-09-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201170-002	LOSARTAN POTASSIUM	50MG	TABLET / ORAL	AB	2012-09-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201170-003	LOSARTAN POTASSIUM	100MG	TABLET / ORAL	AB	2012-09-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201170-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	AB	2012-09-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201170-002	LOSARTAN POTASSIUM	50MG	TABLET / ORAL	AB	2012-09-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201170-003	LOSARTAN POTASSIUM	100MG	TABLET / ORAL	AB	2012-09-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201170-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	AB	2012-09-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201170-002	LOSARTAN POTASSIUM	50MG	TABLET / ORAL	AB	2012-09-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201170-003	LOSARTAN POTASSIUM	100MG	TABLET / ORAL	AB	2012-09-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201170-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	AB	2012-09-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201170-002	LOSARTAN POTASSIUM	50MG	TABLET / ORAL	AB	2012-09-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201170-003	LOSARTAN POTASSIUM	100MG	TABLET / ORAL	AB	2012-09-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201170-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	AB	2012-09-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201170-002	LOSARTAN POTASSIUM	50MG	TABLET / ORAL	AB	2012-09-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201170-003	LOSARTAN POTASSIUM	100MG	TABLET / ORAL	AB	2012-09-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201170-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	AB	2012-09-18	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201170-002	LOSARTAN POTASSIUM	50MG	TABLET / ORAL	AB	2012-09-18	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201170-003	LOSARTAN POTASSIUM	100MG	TABLET / ORAL	AB	2012-09-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A201170-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	AB	2012-09-18	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A201170-002	LOSARTAN POTASSIUM	50MG	TABLET / ORAL	AB	2012-09-18	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A201170-003	LOSARTAN POTASSIUM	100MG	TABLET / ORAL	AB	2012-09-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201170-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	AB	2012-09-18	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201170-002	LOSARTAN POTASSIUM	50MG	TABLET / ORAL	AB	2012-09-18	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201170-003	LOSARTAN POTASSIUM	100MG	TABLET / ORAL	AB	2012-09-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201170-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	AB	2012-09-18	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201170-002	LOSARTAN POTASSIUM	50MG	TABLET / ORAL	AB	2012-09-18	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201170-003	LOSARTAN POTASSIUM	100MG	TABLET / ORAL	AB	2012-09-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201170-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	AB	2012-09-18	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201170-002	LOSARTAN POTASSIUM	50MG	TABLET / ORAL	AB	2012-09-18	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201170-003	LOSARTAN POTASSIUM	100MG	TABLET / ORAL	AB	2012-09-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A201170-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	AB	2012-09-18	`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	A201170-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201170-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201170-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201170-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201170-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201170-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A201170-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201170-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201170-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201170-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201170-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201170-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201170-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201170-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201170-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201170-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201170-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201170-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201170-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201170-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201170-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201170-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201170-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201170-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201170-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201170-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201170-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A201170-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A201170-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A201170-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201170-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201170-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201170-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201170-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201170-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201170-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201170-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201170-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201170-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A201170-001	AB	1	`8072bd15b7f6…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
71610-417-45	EA - Each	71610-417	0cd723ad-2642-4a0b-bd11-c67bf548c9dc	1	2020-06-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71610-417	LOSARTAN POTASSIUM TABLETS, 25 MG (LOSARTAN POTASSIUM) TABLET LOSARTAN POTASSIUM TABLETS, 50 MG (LOSARTAN POTASSIUM) TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1	Legacy NDC	20200508_67828219-e7e2-48f5-9cde-9521e2147222.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 1 · 9 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Losartan potassium Tablets, 25 mg	LOSARTAN POTASSIUM	Bryant Ranch Prepack	7b8f5329-4fdb-4e1d-98b1-de1ca1b171c5	2025-11-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201170 application number: ANDA201170
Losartan potassium Tablets, 100 mg	LOSARTAN POTASSIUM	Bryant Ranch Prepack	726002cf-2d95-4dac-b1f6-e7f92bb13496	2025-11-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201170 application number: ANDA201170
Losartan potassium Tablets, 50 mg	LOSARTAN POTASSIUM	Bryant Ranch Prepack	d67926b0-c22b-4803-b55d-c98a81389449	2025-11-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201170 application number: ANDA201170
Losartan potassium Tablets, 50 mg	LOSARTAN POTASSIUM	Bryant Ranch Prepack	3d7ddcac-508d-459c-96c8-c62f9c0b5193	2025-10-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201170 application number: ANDA201170
Losartan potassium Tablets, 50 mg	LOSARTAN POTASSIUM	Bryant Ranch Prepack	eea03814-3fb5-4f85-8a4d-18e73057d880	2025-09-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201170 application number: ANDA201170
Losartan potassium Tablets, 100 mg	LOSARTAN POTASSIUM	Bryant Ranch Prepack	04c4ba11-a9bd-4fed-bf14-14214f33f9c2	2025-09-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201170 application number: ANDA201170
Losartan potassium Tablets, 25 mg	LOSARTAN POTASSIUM	Bryant Ranch Prepack	ee58207e-3913-4262-87ec-930bb4ecf07b	2025-09-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201170 application number: ANDA201170
Losartan potassium Tablets, 100 mg	LOSARTAN POTASSIUM	Coupler LLC	2d1b03bb-2355-baac-e063-6294a90a9b40	2025-02-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201170 application number: ANDA201170
Losartan potassium Tablets, 25 mg	LOSARTAN POTASSIUM	Jubilant Cadista Pharmaceuticals Inc.	1bf520a2-a50e-a6ae-0fdf-9be4e69729c0	2024-12-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201170 application number: ANDA201170

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
3ST302B24A	LOSARTAN POTASSIUM	124750-99-8	LOSARTAN POTASSIUM

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
71610-417-45	71610041745	45 TABLET in 1 BOTTLE (71610-417-45)	45 tablet	2020-04-23	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Losartan potassium Tablets, 25 mg	Aphena Pharma Solutions - Tennessee, LLC	2020-05-04	HUMAN PRESCRIPTION DRUG LABEL	1