Home NDC 0781-5805 Losartan Potassium
Product NDC 0781-5805
11-digit product format 007815805
Labeler code 0781
Product ID 0781-5805_ea4a85dd-1f98-48ee-98fe-1f4a09340cbd
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name losartan potassium
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Sandoz Inc.
Application NDA020386
Marketing category NDA
Marketing start 1995-04-14
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 E
Listing certified through 2018-12-31
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 · 39 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 0781-5805-92 D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 0781-5805-10 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 0781-5805-92 D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 0781-5805-10 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 0781-5805-92 D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 0781-5805-10 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 0781-5805-92 D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 0781-5805-10 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 0781-5805-92 D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 0781-5805-10 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 0781-5805-92 D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 0781-5805-10 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 0781-5805-92 D Discontinued by firm 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 0781-5805-10 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 0781-5805-92 D Discontinued by firm ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 0781-5805-10 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 0781-5805-92 D Discontinued by firm 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 0781-5805-10 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 0781-5805-92 D Discontinued by firm ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 0781-5805-10 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 0781-5805-92 D Discontinued by firm 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 0781-5805-10 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 0781-5805-92 D Discontinued by firm 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 0781-5805-10 D Discontinued by firm 557ba5c1ecfa…9c80585c8c6e…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 0781-5805-92 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 0781-5805-10 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 N020386-001 COZAAR LOSARTAN POTASSIUM 25MG TABLET / ORAL AB RLD 1995-04-14 N020386-002 COZAAR LOSARTAN POTASSIUM 50MG TABLET / ORAL AB RLD 1995-04-14 N020386-003 COZAAR LOSARTAN POTASSIUM 100MG TABLET / ORAL AB RLD, RS 1998-10-13
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 matching rows.
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 N020386-001 COZAAR 25MG TABLET / ORAL AB RLD 1995-04-14 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N020386-002 COZAAR 50MG TABLET / ORAL AB RLD 1995-04-14 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N020386-003 COZAAR 100MG TABLET / ORAL AB RLD, RS 1998-10-13 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N020386-001 COZAAR 25MG TABLET / ORAL AB RLD 1995-04-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020386-002 COZAAR 50MG TABLET / ORAL AB RLD 1995-04-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020386-003 COZAAR 100MG TABLET / ORAL AB RLD, RS 1998-10-13 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020386-001 COZAAR 25MG TABLET / ORAL AB RLD 1995-04-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020386-002 COZAAR 50MG TABLET / ORAL AB RLD 1995-04-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020386-003 COZAAR 100MG TABLET / ORAL AB RLD, RS 1998-10-13 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N020386-001 COZAAR 25MG TABLET / ORAL AB RLD 1995-04-14 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020386-002 COZAAR 50MG TABLET / ORAL AB RLD 1995-04-14 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020386-003 COZAAR 100MG TABLET / ORAL AB RLD, RS 1998-10-13 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020386-001 COZAAR 25MG TABLET / ORAL AB RLD 1995-04-14 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020386-002 COZAAR 50MG TABLET / ORAL AB RLD 1995-04-14 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020386-003 COZAAR 100MG TABLET / ORAL AB RLD, RS 1998-10-13 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020386-001 COZAAR 25MG TABLET / ORAL AB RLD 1995-04-14 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020386-002 COZAAR 50MG TABLET / ORAL AB RLD 1995-04-14 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020386-003 COZAAR 100MG TABLET / ORAL AB RLD, RS 1998-10-13 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020386-001 COZAAR 25MG TABLET / ORAL AB RLD 1995-04-14 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020386-002 COZAAR 50MG TABLET / ORAL AB RLD 1995-04-14 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020386-003 COZAAR 100MG TABLET / ORAL AB RLD, RS 1998-10-13 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020386-001 COZAAR 25MG TABLET / ORAL AB RLD 1995-04-14 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020386-002 COZAAR 50MG TABLET / ORAL AB RLD 1995-04-14 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020386-003 COZAAR 100MG TABLET / ORAL AB RLD, RS 1998-10-13 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020386-001 COZAAR 25MG TABLET / ORAL AB RLD 1995-04-14 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020386-002 COZAAR 50MG TABLET / ORAL AB RLD 1995-04-14 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020386-003 COZAAR 100MG TABLET / ORAL AB RLD, RS 1998-10-13 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020386-001 COZAAR 25MG TABLET / ORAL AB RLD 1995-04-14 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020386-002 COZAAR 50MG TABLET / ORAL AB RLD 1995-04-14 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020386-003 COZAAR 100MG TABLET / ORAL AB RLD, RS 1998-10-13 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N020386-001 COZAAR 25MG TABLET / ORAL AB RLD 1995-04-14 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N020386-002 COZAAR 50MG TABLET / ORAL AB RLD 1995-04-14 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N020386-003 COZAAR 100MG TABLET / ORAL AB RLD, RS 1998-10-13 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020386-001 COZAAR 25MG TABLET / ORAL AB RLD 1995-04-14 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020386-002 COZAAR 50MG TABLET / ORAL AB RLD 1995-04-14 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020386-003 COZAAR 100MG TABLET / ORAL AB RLD, RS 1998-10-13 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020386-001 COZAAR 25MG TABLET / ORAL AB RLD 1995-04-14 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020386-002 COZAAR 50MG TABLET / ORAL AB RLD 1995-04-14 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020386-003 COZAAR 100MG TABLET / ORAL AB RLD, RS 1998-10-13 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N020386-001 COZAAR 25MG TABLET / ORAL AB RLD 1995-04-14 1e350fbaab3a…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 110 observed states.
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 [SANDOZ INC.] 4 losartan ACTIVE MOIETY JMS50MPO89 LOSARTAN POTASSIUM TABLET, FILM COATED [SANDOZ INC.] 4 CARNAUBA WAX INACTIVE INGREDIENT R12CBM0EIZ LOSARTAN POTASSIUM TABLET, FILM COATED [SANDOZ INC.] 4 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U LOSARTAN POTASSIUM TABLET, FILM COATED [SANDOZ INC.] 4 hydroxypropyl cellulose INACTIVE INGREDIENT RFW2ET671P LOSARTAN POTASSIUM TABLET, FILM COATED [SANDOZ INC.] 4 HYPROMELLOSE INACTIVE INGREDIENT 3NXW29V3WO LOSARTAN POTASSIUM TABLET, FILM COATED [SANDOZ INC.] 4 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X LOSARTAN POTASSIUM TABLET, FILM COATED [SANDOZ INC.] 4 magnesium stearate INACTIVE INGREDIENT 70097M6I30 LOSARTAN POTASSIUM TABLET, FILM COATED [SANDOZ INC.] 4 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ LOSARTAN POTASSIUM TABLET, FILM COATED [SANDOZ INC.] 4 titanium dioxide INACTIVE INGREDIENT 15FIX9V2JP LOSARTAN POTASSIUM TABLET, FILM COATED [SANDOZ INC.] 4
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 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join COZAAR LOSARTAN POTASSIUM Organon LLC 9949448f-c3b9-44ee-94ed-c1aca8c90f39 2026-01-20 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 020386 application number: NDA020386