Home NDC 0615-7604 Losartan Potassium
Product NDC 0615-7604
11-digit product format 006157604
Labeler code 0615
Product ID 0615-7604_21e68075-8d82-4bd8-be9c-05ef2647dc20
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Losartan Potassium
Dosage form TABLET, FILM COATED
Route ORAL
Labeler NCS HealthCare of KY, Inc dba Vangard Labs
Application ANDA076958
Marketing category ANDA
Marketing start 2010-04-06
Marketing end 0000-00-00
Substance LOSARTAN POTASSIUM
Active strength 100 mg/1
Pharmacologic classes Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC]
NDC exclude flag E
Listing certified through 2017-12-31
Current FDA listing Historical FDA.report record 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 · 30 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 0615-7604-39 D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 0615-7604-39 D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 0615-7604-39 D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 0615-7604-39 D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 0615-7604-39 D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 0615-7604-39 D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product D Discontinued by firm 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 0615-7604-39 D Discontinued by firm 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product D Discontinued by firm ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 0615-7604-39 D Discontinued by firm ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product D Discontinued by firm 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 0615-7604-39 D Discontinued by firm 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product D Discontinued by firm ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 0615-7604-39 D Discontinued by firm ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product D Discontinued by firm 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 0615-7604-39 D Discontinued by firm 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product D Discontinued by firm 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 0615-7604-39 D Discontinued by firm 557ba5c1ecfa…9c80585c8c6e…2020-12-18 03:04 UTC · source 2020-12-17 excluded product product I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-12-18 03:04 UTC · source 2020-12-17 excluded package package 0615-7604-39 I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-06-10 20:45 UTC · source 2020-06-10 excluded product product I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 0615-7604-39 I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2019-12-08 06:16 UTC · source 2019-12-05 excluded product product E Excluded after deficient or non-compliant submission was not corrected 110d247fa046…a55b01930146…2019-12-08 06:16 UTC · source 2019-12-05 excluded package package 0615-7604-39 E Excluded after deficient or non-compliant submission was not corrected 110d247fa046…a55b01930146…
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 RLD / RS 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 Product TE source text RLD / RS 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# FDA-Initiated Inactive NDC Indexing# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded LOSARTAN POTASSIUM ACTIVE INGREDIENT 3ST302B24A LOSARTAN POTASSIUM TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 17 LOSARTAN ACTIVE MOIETY JMS50MPO89 LOSARTAN POTASSIUM TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 17 ALUMINUM OXIDE INACTIVE INGREDIENT LMI26O6933 LOSARTAN POTASSIUM TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 17 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U LOSARTAN POTASSIUM TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 17 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G LOSARTAN POTASSIUM TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 17 FD&C BLUE NO. 2 INACTIVE INGREDIENT L06K8R7DQK LOSARTAN POTASSIUM TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 17 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 LOSARTAN POTASSIUM TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 17 INDIGOTINDISULFONATE SODIUM INACTIVE INGREDIENT D3741U8K7L LOSARTAN POTASSIUM TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 17 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X LOSARTAN POTASSIUM TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 17 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 LOSARTAN POTASSIUM TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 17 POLYETHYLENE GLYCOL 3350 INACTIVE INGREDIENT G2M7P15E5P LOSARTAN POTASSIUM TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 17 POLYETHYLENE GLYCOL 4000 INACTIVE INGREDIENT 4R4HFI6D95 LOSARTAN POTASSIUM TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 17 POLYVINYL ALCOHOL INACTIVE INGREDIENT 532B59J990 LOSARTAN POTASSIUM TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 17 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ LOSARTAN POTASSIUM TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 17 TALC INACTIVE INGREDIENT 7SEV7J4R1U LOSARTAN POTASSIUM TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 17 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP LOSARTAN POTASSIUM TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 17