Home NDC 78206-121 COZAAR
Product NDC 78206-121
11-digit product format 782060121
Labeler code 78206
Product ID 78206-121_998b309b-7dde-4d62-b902-010dd83108fe
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name losartan potassium
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Organon LLC
Application NDA020386
Marketing category NDA
Marketing start 2021-06-01
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 2027-12-31
Current FDA listing Yes 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.
Additional Listing Data#
Finished product Yes
Brand name base COZAAR
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength LOSARTAN POTASSIUM 25 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 3ST302B24A Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 6 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 979480 Internal RxNorm lookup 979482 Internal RxNorm lookup 979485 Internal RxNorm lookup 979487 Internal RxNorm lookup 979492 Internal RxNorm lookup 979494 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 78206-121-01 COZAAR 90 in 1 BOTTLE TABLET, FILM COATED 90 9
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 78206-121 COZAAR (LOSARTAN POTASSIUM) TABLET, FILM COATED [ORGANON LLC] 6 Current NDC, Legacy NDC, 1 package rows 20241123_9949448f-c3b9-44ee-94ed-c1aca8c90f39.zip
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 ndc (product): 78206-121
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 78206-121-01 78206012101 90 TABLET, FILM COATED in 1 BOTTLE (78206-121-01) 2021-06-01 0000-00-00 No No Current