Home NDC 55289-238 COZAAR
Product NDC 55289-238
11-digit product format 552890238
Labeler code 55289
Product ID 55289-238_d2453978-0677-65e3-e053-2995a90a085f
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name losartan potassium
Dosage form TABLET, FILM COATED
Route ORAL
Labeler PD-Rx Pharmaceuticals, Inc.
Application NDA020386
Marketing category NDA
Marketing start 1995-04-14
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 No
Listing certified through 2022-12-31
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 · 24 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 55289-238-30 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 55289-238-30 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 55289-238-30 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 55289-238-30 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 55289-238-30 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 55289-238-30 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 55289-238-30 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 55289-238-30 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 55289-238-30 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 55289-238-30 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 55289-238-30 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 55289-238-30 557ba5c1ecfa…9c80585c8c6e…
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 COZAAR (LOSARTAN POTASSIUM) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 15 losartan ACTIVE MOIETY JMS50MPO89 COZAAR (LOSARTAN POTASSIUM) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 15 CARNAUBA WAX INACTIVE INGREDIENT R12CBM0EIZ COZAAR (LOSARTAN POTASSIUM) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 15 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U COZAAR (LOSARTAN POTASSIUM) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 15 hydroxypropyl cellulose INACTIVE INGREDIENT RFW2ET671P COZAAR (LOSARTAN POTASSIUM) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 15 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO COZAAR (LOSARTAN POTASSIUM) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 15 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X COZAAR (LOSARTAN POTASSIUM) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 15 magnesium stearate INACTIVE INGREDIENT 70097M6I30 COZAAR (LOSARTAN POTASSIUM) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 15 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ COZAAR (LOSARTAN POTASSIUM) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 15 titanium dioxide INACTIVE INGREDIENT 15FIX9V2JP COZAAR (LOSARTAN POTASSIUM) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 15
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
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 55289-238-30 55289023830 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55289-238-30) 2011-11-21 0000-00-00 No No Current