Home NDC 42571-201 OLMESARTAN MEDOXOMIL
Product NDC 42571-201
11-digit product format 425710201
Labeler code 42571
Product ID 42571-201_3619c2a8-fac7-3b89-e063-6294a90a7209
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name olmesartan medoxomil
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Micro Labs Limited
Application ANDA206372
Marketing category ANDA
Marketing start 2020-02-03
Substance OLMESARTAN MEDOXOMIL
Active strength 5 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 A206372-001 OLMESARTAN MEDOXOMIL OLMESARTAN MEDOXOMIL 5MG TABLET / ORAL AB 2019-09-17 A206372-002 OLMESARTAN MEDOXOMIL OLMESARTAN MEDOXOMIL 20MG TABLET / ORAL AB 2019-09-17 A206372-003 OLMESARTAN MEDOXOMIL OLMESARTAN MEDOXOMIL 40MG TABLET / ORAL AB 2019-09-17
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 3 · 117 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 A206372-001 OLMESARTAN MEDOXOMIL 5MG TABLET / ORAL AB 2019-09-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A206372-002 OLMESARTAN MEDOXOMIL 20MG TABLET / ORAL AB 2019-09-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A206372-003 OLMESARTAN MEDOXOMIL 40MG TABLET / ORAL AB 2019-09-17 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A206372-001 OLMESARTAN MEDOXOMIL 5MG TABLET / ORAL AB 2019-09-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A206372-002 OLMESARTAN MEDOXOMIL 20MG TABLET / ORAL AB 2019-09-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A206372-003 OLMESARTAN MEDOXOMIL 40MG TABLET / ORAL AB 2019-09-17 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A206372-001 OLMESARTAN MEDOXOMIL 5MG TABLET / ORAL AB 2019-09-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A206372-002 OLMESARTAN MEDOXOMIL 20MG TABLET / ORAL AB 2019-09-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A206372-003 OLMESARTAN MEDOXOMIL 40MG TABLET / ORAL AB 2019-09-17 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A206372-001 OLMESARTAN MEDOXOMIL 5MG TABLET / ORAL AB 2019-09-17 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A206372-002 OLMESARTAN MEDOXOMIL 20MG TABLET / ORAL AB 2019-09-17 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A206372-003 OLMESARTAN MEDOXOMIL 40MG TABLET / ORAL AB 2019-09-17 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A206372-001 OLMESARTAN MEDOXOMIL 5MG TABLET / ORAL AB 2019-09-17 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A206372-002 OLMESARTAN MEDOXOMIL 20MG TABLET / ORAL AB 2019-09-17 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A206372-003 OLMESARTAN MEDOXOMIL 40MG TABLET / ORAL AB 2019-09-17 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A206372-001 OLMESARTAN MEDOXOMIL 5MG TABLET / ORAL AB 2019-09-17 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A206372-002 OLMESARTAN MEDOXOMIL 20MG TABLET / ORAL AB 2019-09-17 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A206372-003 OLMESARTAN MEDOXOMIL 40MG TABLET / ORAL AB 2019-09-17 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A206372-001 OLMESARTAN MEDOXOMIL 5MG TABLET / ORAL AB 2019-09-17 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A206372-002 OLMESARTAN MEDOXOMIL 20MG TABLET / ORAL AB 2019-09-17 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A206372-003 OLMESARTAN MEDOXOMIL 40MG TABLET / ORAL AB 2019-09-17 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A206372-001 OLMESARTAN MEDOXOMIL 5MG TABLET / ORAL AB 2019-09-17 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A206372-002 OLMESARTAN MEDOXOMIL 20MG TABLET / ORAL AB 2019-09-17 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A206372-003 OLMESARTAN MEDOXOMIL 40MG TABLET / ORAL AB 2019-09-17 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A206372-001 OLMESARTAN MEDOXOMIL 5MG TABLET / ORAL AB 2019-09-17 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A206372-002 OLMESARTAN MEDOXOMIL 20MG TABLET / ORAL AB 2019-09-17 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A206372-003 OLMESARTAN MEDOXOMIL 40MG TABLET / ORAL AB 2019-09-17 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A206372-001 OLMESARTAN MEDOXOMIL 5MG TABLET / ORAL AB 2019-09-17 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A206372-002 OLMESARTAN MEDOXOMIL 20MG TABLET / ORAL AB 2019-09-17 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A206372-003 OLMESARTAN MEDOXOMIL 40MG TABLET / ORAL AB 2019-09-17 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A206372-001 OLMESARTAN MEDOXOMIL 5MG TABLET / ORAL AB 2019-09-17 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A206372-002 OLMESARTAN MEDOXOMIL 20MG TABLET / ORAL AB 2019-09-17 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A206372-003 OLMESARTAN MEDOXOMIL 40MG TABLET / ORAL AB 2019-09-17 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A206372-001 OLMESARTAN MEDOXOMIL 5MG TABLET / ORAL AB 2019-09-17 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A206372-002 OLMESARTAN MEDOXOMIL 20MG TABLET / ORAL AB 2019-09-17 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A206372-003 OLMESARTAN MEDOXOMIL 40MG TABLET / ORAL AB 2019-09-17 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A206372-001 OLMESARTAN MEDOXOMIL 5MG TABLET / ORAL AB 2019-09-17 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A206372-002 OLMESARTAN MEDOXOMIL 20MG TABLET / ORAL AB 2019-09-17 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A206372-003 OLMESARTAN MEDOXOMIL 40MG TABLET / ORAL AB 2019-09-17 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A206372-001 OLMESARTAN MEDOXOMIL 5MG TABLET / ORAL AB 2019-09-17 8072bd15b7f6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 117 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 5 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 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 349373 Internal RxNorm lookup 349401 Internal RxNorm lookup 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 42571-201-05 OLMESARTAN MEDOXOMIL 500 in 1 BOTTLE TABLET, FILM COATED 500 7 42571-201-10 OLMESARTAN MEDOXOMIL 1000 in 1 BOTTLE TABLET, FILM COATED 1000 7 42571-201-11 OLMESARTAN MEDOXOMIL 10 in 1 CARTON TABLET, FILM COATED 10 7 42571-201-30 OLMESARTAN MEDOXOMIL 30 in 1 BOTTLE TABLET, FILM COATED 30 7 42571-201-32 OLMESARTAN MEDOXOMIL 10 in 1 BLISTER PACK TABLET, FILM COATED 10 7 42571-201-90 OLMESARTAN MEDOXOMIL 90 in 1 BOTTLE TABLET, FILM COATED 90 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 42571-201 OLMESARTAN MEDOXOMIL TABLET, FILM COATED [MICRO LABS LIMITED] 7 Current NDC, Legacy NDC, 6 package rows 20250529_de799a31-50ae-4b9e-a159-3d399b523dca.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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 42571-201-05 42571020105 500 TABLET, FILM COATED in 1 BOTTLE (42571-201-05) 2020-02-03 0000-00-00 No No Current 42571-201-10 42571020110 1000 TABLET, FILM COATED in 1 BOTTLE (42571-201-10) 2020-02-03 0000-00-00 No No Current 42571-201-11 42571020111 10 BLISTER PACK in 1 CARTON (42571-201-11) / 10 TABLET, FILM COATED in 1 BLISTER PACK (42571-201-32) 10 blister pack 2020-02-03 0000-00-00 No No Current 42571-201-30 42571020130 30 TABLET, FILM COATED in 1 BOTTLE (42571-201-30) 2020-02-03 0000-00-00 No No Current 42571-201-32 42571020132 10 in 1 BLISTER PACK Historical 42571-201-90 42571020190 90 TABLET, FILM COATED in 1 BOTTLE (42571-201-90) 2020-02-03 0000-00-00 No No Current