Losartan Potassium

Product NDC
71610-065
11-digit product format
716100065
Labeler code
71610
Product ID
71610-065_0fd17d3c-5eba-43af-9c72-e97d8dd6623b
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
25 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 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct71610-065DDiscontinued by firm2026-08-17
excluded packagepackage71610-06571610-065-45DDiscontinued by firm2026-08-17
excluded packagepackage71610-06571610-065-60DDiscontinued by firm2026-08-17

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 · 6 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage71610-065-45d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage71610-065-60d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage71610-065-45f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage71610-065-60f5e01cc5f278…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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A076958-001LOSARTAN POTASSIUMLOSARTAN POTASSIUM25MGTABLET / ORAL2010-04-06
A076958-002LOSARTAN POTASSIUMLOSARTAN POTASSIUM50MGTABLET / ORAL2010-04-06
A076958-003LOSARTAN POTASSIUMLOSARTAN POTASSIUM100MGTABLET / ORAL2010-04-06

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A076958-001LOSARTAN POTASSIUM25MGTABLET / ORAL2010-04-06caaa826d4ba7…
2026-08-18 06:07:402026-07A076958-002LOSARTAN POTASSIUM50MGTABLET / ORAL2010-04-06caaa826d4ba7…
2026-08-18 06:07:402026-07A076958-003LOSARTAN POTASSIUM100MGTABLET / ORAL2010-04-06caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A076958-001LOSARTAN POTASSIUM25MGTABLET / ORAL2010-04-06011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076958-002LOSARTAN POTASSIUM50MGTABLET / ORAL2010-04-06011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076958-003LOSARTAN POTASSIUM100MGTABLET / ORAL2010-04-06011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076958-001LOSARTAN POTASSIUM25MGTABLET / ORAL2010-04-0631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076958-002LOSARTAN POTASSIUM50MGTABLET / ORAL2010-04-0631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076958-003LOSARTAN POTASSIUM100MGTABLET / ORAL2010-04-0631067a03dcf5…
2025-08-23 18:47 UTC2025-08A076958-001LOSARTAN POTASSIUM25MGTABLET / ORAL2010-04-066a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076958-002LOSARTAN POTASSIUM50MGTABLET / ORAL2010-04-066a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076958-003LOSARTAN POTASSIUM100MGTABLET / ORAL2010-04-066a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076958-001LOSARTAN POTASSIUM25MGTABLET / ORAL2010-04-06fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076958-002LOSARTAN POTASSIUM50MGTABLET / ORAL2010-04-06fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076958-003LOSARTAN POTASSIUM100MGTABLET / ORAL2010-04-06fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076958-001LOSARTAN POTASSIUM25MGTABLET / ORAL2010-04-06b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076958-002LOSARTAN POTASSIUM50MGTABLET / ORAL2010-04-06b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076958-003LOSARTAN POTASSIUM100MGTABLET / ORAL2010-04-06b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076958-001LOSARTAN POTASSIUM25MGTABLET / ORAL2010-04-0603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076958-002LOSARTAN POTASSIUM50MGTABLET / ORAL2010-04-0603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076958-003LOSARTAN POTASSIUM100MGTABLET / ORAL2010-04-0603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076958-001LOSARTAN POTASSIUM25MGTABLET / ORAL2010-04-062680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076958-002LOSARTAN POTASSIUM50MGTABLET / ORAL2010-04-062680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076958-003LOSARTAN POTASSIUM100MGTABLET / ORAL2010-04-062680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076958-001LOSARTAN POTASSIUM25MGTABLET / ORAL2010-04-065bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076958-002LOSARTAN POTASSIUM50MGTABLET / ORAL2010-04-065bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076958-003LOSARTAN POTASSIUM100MGTABLET / ORAL2010-04-065bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076958-001LOSARTAN POTASSIUM25MGTABLET / ORAL2010-04-06d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076958-002LOSARTAN POTASSIUM50MGTABLET / ORAL2010-04-06d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076958-003LOSARTAN POTASSIUM100MGTABLET / ORAL2010-04-06d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A076958-001LOSARTAN POTASSIUM25MGTABLET / ORAL2010-04-06d06236e962d9…
2024-10-29 15:01 UTC2024-10A076958-002LOSARTAN POTASSIUM50MGTABLET / ORAL2010-04-06d06236e962d9…
2024-10-29 15:01 UTC2024-10A076958-003LOSARTAN POTASSIUM100MGTABLET / ORAL2010-04-06d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076958-001LOSARTAN POTASSIUM25MGTABLET / ORAL2010-04-0679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076958-002LOSARTAN POTASSIUM50MGTABLET / ORAL2010-04-0679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076958-003LOSARTAN POTASSIUM100MGTABLET / ORAL2010-04-0679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076958-001LOSARTAN POTASSIUM25MGTABLET / ORAL2010-04-06301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076958-002LOSARTAN POTASSIUM50MGTABLET / ORAL2010-04-06301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076958-003LOSARTAN POTASSIUM100MGTABLET / ORAL2010-04-06301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076958-001LOSARTAN POTASSIUM25MGTABLET / ORAL2010-04-061e350fbaab3a…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2019-07-19 19:46 UTC2019-07A076958-001AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A076958-002AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A076958-003AB1ea99ee380514…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0d341e63-aee5-498b-bf9a-b53a43963acfProduct name120260105
de29c5c0-90ba-29da-d7ab-0500274708beProduct name620241009
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
351abe41-466c-4dd8-840a-0fdb68318bd5Product name120230316
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
15b375b1-89c7-9594-80df-5a8c8864aee0Product name320180108
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71610-065-45EA - Each71610-06555f7bd7e-0a0c-4120-9ce3-50f2de0fb6f112018-08-13
71610-065-60EA - Each71610-0650c4e4c8e-dba8-4fe6-99db-09078c6e5f8712018-08-13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71610-065-457161000654545 TABLET, FILM COATED in 1 BOTTLE (71610-065-45) 2018-05-170000-00-00NoNoCurrent
71610-065-607161000656090 TABLET, FILM COATED in 1 BOTTLE (71610-065-60) 2018-05-250000-00-00NoNoCurrent