Losartan Potassium

Product NDC: 71610-009
11-digit product format: 716100009
Labeler code: 71610
Product ID: 71610-009_c3a76330-eefb-4b9d-acbf-571bb6833dff
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Losartan Potassium
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Aphena Pharma Solutions - Tennessee, LLC
Application: ANDA076958
Marketing category: ANDA
Marketing start: 2017-03-09
Marketing end: 0000-00-00
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: 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 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	71610-009		D	Discontinued by firm	2026-08-17
excluded package	package	71610-009	71610-009-30	D	Discontinued by firm	2026-08-17
excluded package	package	71610-009	71610-009-45	D	Discontinued by firm	2026-08-17
excluded package	package	71610-009	71610-009-60	D	Discontinued by firm	2026-08-17

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 · 8 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	71610-009-45	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	71610-009-60	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	71610-009-30	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	71610-009-45	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	71610-009-60	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	71610-009-30	`f5e01cc5f278…`	`a2eaf40c39c3…`

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	Approval date
A076958-001	LOSARTAN POTASSIUM	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	2010-04-06
A076958-002	LOSARTAN POTASSIUM	LOSARTAN POTASSIUM	50MG	TABLET / ORAL	2010-04-06
A076958-003	LOSARTAN POTASSIUM	LOSARTAN POTASSIUM	100MG	TABLET / ORAL	2010-04-06

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 · 126 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A076958-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	2010-04-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076958-002	LOSARTAN POTASSIUM	50MG	TABLET / ORAL	2010-04-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076958-003	LOSARTAN POTASSIUM	100MG	TABLET / ORAL	2010-04-06	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076958-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	2010-04-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076958-002	LOSARTAN POTASSIUM	50MG	TABLET / ORAL	2010-04-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076958-003	LOSARTAN POTASSIUM	100MG	TABLET / ORAL	2010-04-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076958-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	2010-04-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076958-002	LOSARTAN POTASSIUM	50MG	TABLET / ORAL	2010-04-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076958-003	LOSARTAN POTASSIUM	100MG	TABLET / ORAL	2010-04-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076958-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	2010-04-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076958-002	LOSARTAN POTASSIUM	50MG	TABLET / ORAL	2010-04-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076958-003	LOSARTAN POTASSIUM	100MG	TABLET / ORAL	2010-04-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076958-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	2010-04-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076958-002	LOSARTAN POTASSIUM	50MG	TABLET / ORAL	2010-04-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076958-003	LOSARTAN POTASSIUM	100MG	TABLET / ORAL	2010-04-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076958-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	2010-04-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076958-002	LOSARTAN POTASSIUM	50MG	TABLET / ORAL	2010-04-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076958-003	LOSARTAN POTASSIUM	100MG	TABLET / ORAL	2010-04-06	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076958-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	2010-04-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076958-002	LOSARTAN POTASSIUM	50MG	TABLET / ORAL	2010-04-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076958-003	LOSARTAN POTASSIUM	100MG	TABLET / ORAL	2010-04-06	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076958-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	2010-04-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076958-002	LOSARTAN POTASSIUM	50MG	TABLET / ORAL	2010-04-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076958-003	LOSARTAN POTASSIUM	100MG	TABLET / ORAL	2010-04-06	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076958-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	2010-04-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076958-002	LOSARTAN POTASSIUM	50MG	TABLET / ORAL	2010-04-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076958-003	LOSARTAN POTASSIUM	100MG	TABLET / ORAL	2010-04-06	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076958-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	2010-04-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076958-002	LOSARTAN POTASSIUM	50MG	TABLET / ORAL	2010-04-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076958-003	LOSARTAN POTASSIUM	100MG	TABLET / ORAL	2010-04-06	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076958-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	2010-04-06	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076958-002	LOSARTAN POTASSIUM	50MG	TABLET / ORAL	2010-04-06	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076958-003	LOSARTAN POTASSIUM	100MG	TABLET / ORAL	2010-04-06	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076958-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	2010-04-06	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076958-002	LOSARTAN POTASSIUM	50MG	TABLET / ORAL	2010-04-06	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076958-003	LOSARTAN POTASSIUM	100MG	TABLET / ORAL	2010-04-06	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076958-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	2010-04-06	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076958-002	LOSARTAN POTASSIUM	50MG	TABLET / ORAL	2010-04-06	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076958-003	LOSARTAN POTASSIUM	100MG	TABLET / ORAL	2010-04-06	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076958-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	2010-04-06	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-07-19 19:46 UTC	2019-07	A076958-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A076958-002	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A076958-003	AB	1	`ea99ee380514…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
71610-009-30	EA - Each	71610-009	a71d27d2-2bc0-41ba-adae-a9b13bc8df04	1	2019-05-02
71610-009-45	EA - Each	71610-009	e37a7274-fba5-4e71-a4dd-293bdfe0e97f	1	2018-02-20
71610-009-60	EA - Each	71610-009	0243272e-ee51-4b0f-95e4-abbe44950368	1	2019-05-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71610-009	LOSARTAN POTASSIUM TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2	Legacy NDC	20190424_bb9c36f6-7129-417c-970a-3028a828c8ee.zip

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	Marketing start	Marketing end	Sample	Exclude flag	Status
71610-009-30	71610000930	30 TABLET, FILM COATED in 1 BOTTLE (71610-009-30)	2018-06-12	0000-00-00	No	No	Current
71610-009-45	71610000945	45 TABLET, FILM COATED in 1 BOTTLE (71610-009-45)	2017-10-30	0000-00-00	No	No	Current
71610-009-60	71610000960	90 TABLET, FILM COATED in 1 BOTTLE (71610-009-60)	2017-12-18	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Losartan Potassium	Aphena Pharma Solutions - Tennessee, LLC	2019-04-04	HUMAN PRESCRIPTION DRUG LABEL	2