Home NDC 50090-6633 Olmesartan medoxomil
Product NDC 50090-6633
11-digit product format 500906633
Labeler code 50090
Product ID 50090-6633_606e4657-7d61-4f7b-bbb5-93e05d1f70ff
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Olmesartan medoxomil
Dosage form TABLET
Route ORAL
Labeler A-S Medication Solutions
Application ANDA204814
Marketing category ANDA
Marketing start 2017-04-25
Substance OLMESARTAN MEDOXOMIL
Active strength 40 mg/1
Pharmacologic classes Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
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 A204814-001 OLMESARTAN MEDOXOMIL OLMESARTAN MEDOXOMIL 5MG TABLET / ORAL AB 2017-04-24 A204814-002 OLMESARTAN MEDOXOMIL OLMESARTAN MEDOXOMIL 20MG TABLET / ORAL AB 2017-04-24 A204814-003 OLMESARTAN MEDOXOMIL OLMESARTAN MEDOXOMIL 40MG TABLET / ORAL AB 2017-04-24
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 · 123 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 2026-02-19 14:30 UTC 2026-02 A204814-001 OLMESARTAN MEDOXOMIL 5MG TABLET / ORAL AB 2017-04-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A204814-002 OLMESARTAN MEDOXOMIL 20MG TABLET / ORAL AB 2017-04-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A204814-003 OLMESARTAN MEDOXOMIL 40MG TABLET / ORAL AB 2017-04-24 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A204814-001 OLMESARTAN MEDOXOMIL 5MG TABLET / ORAL AB 2017-04-24 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A204814-002 OLMESARTAN MEDOXOMIL 20MG TABLET / ORAL AB 2017-04-24 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A204814-003 OLMESARTAN MEDOXOMIL 40MG TABLET / ORAL AB 2017-04-24 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A204814-001 OLMESARTAN MEDOXOMIL 5MG TABLET / ORAL AB 2017-04-24 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A204814-002 OLMESARTAN MEDOXOMIL 20MG TABLET / ORAL AB 2017-04-24 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A204814-003 OLMESARTAN MEDOXOMIL 40MG TABLET / ORAL AB 2017-04-24 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A204814-001 OLMESARTAN MEDOXOMIL 5MG TABLET / ORAL AB 2017-04-24 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A204814-002 OLMESARTAN MEDOXOMIL 20MG TABLET / ORAL AB 2017-04-24 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A204814-003 OLMESARTAN MEDOXOMIL 40MG TABLET / ORAL AB 2017-04-24 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A204814-001 OLMESARTAN MEDOXOMIL 5MG TABLET / ORAL AB 2017-04-24 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A204814-002 OLMESARTAN MEDOXOMIL 20MG TABLET / ORAL AB 2017-04-24 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A204814-003 OLMESARTAN MEDOXOMIL 40MG TABLET / ORAL AB 2017-04-24 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A204814-001 OLMESARTAN MEDOXOMIL 5MG TABLET / ORAL AB 2017-04-24 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A204814-002 OLMESARTAN MEDOXOMIL 20MG TABLET / ORAL AB 2017-04-24 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A204814-003 OLMESARTAN MEDOXOMIL 40MG TABLET / ORAL AB 2017-04-24 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A204814-001 OLMESARTAN MEDOXOMIL 5MG TABLET / ORAL AB 2017-04-24 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A204814-002 OLMESARTAN MEDOXOMIL 20MG TABLET / ORAL AB 2017-04-24 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A204814-003 OLMESARTAN MEDOXOMIL 40MG TABLET / ORAL AB 2017-04-24 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A204814-001 OLMESARTAN MEDOXOMIL 5MG TABLET / ORAL AB 2017-04-24 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A204814-002 OLMESARTAN MEDOXOMIL 20MG TABLET / ORAL AB 2017-04-24 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A204814-003 OLMESARTAN MEDOXOMIL 40MG TABLET / ORAL AB 2017-04-24 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A204814-001 OLMESARTAN MEDOXOMIL 5MG TABLET / ORAL AB 2017-04-24 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A204814-002 OLMESARTAN MEDOXOMIL 20MG TABLET / ORAL AB 2017-04-24 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A204814-003 OLMESARTAN MEDOXOMIL 40MG TABLET / ORAL AB 2017-04-24 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A204814-001 OLMESARTAN MEDOXOMIL 5MG TABLET / ORAL AB 2017-04-24 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A204814-002 OLMESARTAN MEDOXOMIL 20MG TABLET / ORAL AB 2017-04-24 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A204814-003 OLMESARTAN MEDOXOMIL 40MG TABLET / ORAL AB 2017-04-24 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A204814-001 OLMESARTAN MEDOXOMIL 5MG TABLET / ORAL AB 2017-04-24 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A204814-002 OLMESARTAN MEDOXOMIL 20MG TABLET / ORAL AB 2017-04-24 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A204814-003 OLMESARTAN MEDOXOMIL 40MG TABLET / ORAL AB 2017-04-24 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A204814-001 OLMESARTAN MEDOXOMIL 5MG TABLET / ORAL AB 2017-04-24 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A204814-002 OLMESARTAN MEDOXOMIL 20MG TABLET / ORAL AB 2017-04-24 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A204814-003 OLMESARTAN MEDOXOMIL 40MG TABLET / ORAL AB 2017-04-24 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A204814-001 OLMESARTAN MEDOXOMIL 5MG TABLET / ORAL AB 2017-04-24 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A204814-002 OLMESARTAN MEDOXOMIL 20MG TABLET / ORAL AB 2017-04-24 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A204814-003 OLMESARTAN MEDOXOMIL 40MG TABLET / ORAL AB 2017-04-24 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A204814-001 OLMESARTAN MEDOXOMIL 5MG TABLET / ORAL AB 2017-04-24 8072bd15b7f6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 123 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Olmesartan medoxomil
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength OLMESARTAN MEDOXOMIL 40 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 6M97XTV3HD Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 349405 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 50090-6633-0 Olmesartan medoxomil 90 in 1 BOTTLE TABLET 90 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50090-6633 OLMESARTAN MEDOXOMIL TABLET [A-S MEDICATION SOLUTIONS] 1 Current NDC, 1 package rows 20230913_9d9f1c08-4f65-484c-943e-7e664281910f.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 · 4 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Olmesartan medoxomil OLMESARTAN MEDOXOMIL REMEDYREPACK INC. 85a24657-583b-4776-98c9-b30285cb3058 2026-03-26 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 204814 application number: ANDA204814 Olmesartan medoxomil OLMESARTAN MEDOXOMIL Macleods Pharmaceuticals Limited 24e308cc-7cec-4054-9627-66f743ed71b0 2025-09-10 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 204814 application number: ANDA204814 Olmesartan medoxomil OLMESARTAN MEDOXOMIL A-S Medication Solutions 9d9f1c08-4f65-484c-943e-7e664281910f 2023-09-12 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 204814 application number: ANDA204814 ndc (product): 50090-6633 Olmesartan medoxomil OLMESARTAN MEDOXOMIL A-S Medication Solutions 5f410909-a68a-4ada-963a-32018d37572f 2023-09-11 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 204814 application number: ANDA204814
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 50090-6633-0 50090663300 90 TABLET in 1 BOTTLE (50090-6633-0) 90 tablet 2023-08-25 No No Current