Home NDC 50090-4451 Olmesartan Medoxomil
Product NDC 50090-4451
11-digit product format 500904451
Labeler code 50090
Product ID 50090-4451_65f41aa8-81da-4c9d-a51d-56f811bd91a4
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Olmesartan Medoxomil
Dosage form TABLET, FILM COATED
Route ORAL
Labeler A-S Medication Solutions
Application ANDA203281
Marketing category ANDA
Marketing start 2017-05-25
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 2027-12-31
Current FDA listing Yes 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 · 45 matching rows.
View current auxiliary records. · View the auxiliary file history.
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 A203281-001 OLMESARTAN MEDOXOMIL OLMESARTAN MEDOXOMIL 5MG TABLET / ORAL AB 2017-05-25 A203281-002 OLMESARTAN MEDOXOMIL OLMESARTAN MEDOXOMIL 20MG TABLET / ORAL AB 2017-05-25 A203281-003 OLMESARTAN MEDOXOMIL OLMESARTAN MEDOXOMIL 40MG TABLET / ORAL AB 2017-05-25
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 A203281-001 OLMESARTAN MEDOXOMIL 5MG TABLET / ORAL AB 2017-05-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A203281-002 OLMESARTAN MEDOXOMIL 20MG TABLET / ORAL AB 2017-05-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A203281-003 OLMESARTAN MEDOXOMIL 40MG TABLET / ORAL AB 2017-05-25 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203281-001 OLMESARTAN MEDOXOMIL 5MG TABLET / ORAL AB 2017-05-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203281-002 OLMESARTAN MEDOXOMIL 20MG TABLET / ORAL AB 2017-05-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203281-003 OLMESARTAN MEDOXOMIL 40MG TABLET / ORAL AB 2017-05-25 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A203281-001 OLMESARTAN MEDOXOMIL 5MG TABLET / ORAL AB 2017-05-25 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A203281-002 OLMESARTAN MEDOXOMIL 20MG TABLET / ORAL AB 2017-05-25 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A203281-003 OLMESARTAN MEDOXOMIL 40MG TABLET / ORAL AB 2017-05-25 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203281-001 OLMESARTAN MEDOXOMIL 5MG TABLET / ORAL AB 2017-05-25 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203281-002 OLMESARTAN MEDOXOMIL 20MG TABLET / ORAL AB 2017-05-25 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203281-003 OLMESARTAN MEDOXOMIL 40MG TABLET / ORAL AB 2017-05-25 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203281-001 OLMESARTAN MEDOXOMIL 5MG TABLET / ORAL AB 2017-05-25 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203281-002 OLMESARTAN MEDOXOMIL 20MG TABLET / ORAL AB 2017-05-25 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203281-003 OLMESARTAN MEDOXOMIL 40MG TABLET / ORAL AB 2017-05-25 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203281-001 OLMESARTAN MEDOXOMIL 5MG TABLET / ORAL AB 2017-05-25 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203281-002 OLMESARTAN MEDOXOMIL 20MG TABLET / ORAL AB 2017-05-25 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203281-003 OLMESARTAN MEDOXOMIL 40MG TABLET / ORAL AB 2017-05-25 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203281-001 OLMESARTAN MEDOXOMIL 5MG TABLET / ORAL AB 2017-05-25 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203281-002 OLMESARTAN MEDOXOMIL 20MG TABLET / ORAL AB 2017-05-25 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203281-003 OLMESARTAN MEDOXOMIL 40MG TABLET / ORAL AB 2017-05-25 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A203281-001 OLMESARTAN MEDOXOMIL 5MG TABLET / ORAL AB 2017-05-25 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A203281-002 OLMESARTAN MEDOXOMIL 20MG TABLET / ORAL AB 2017-05-25 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A203281-003 OLMESARTAN MEDOXOMIL 40MG TABLET / ORAL AB 2017-05-25 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A203281-001 OLMESARTAN MEDOXOMIL 5MG TABLET / ORAL AB 2017-05-25 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A203281-002 OLMESARTAN MEDOXOMIL 20MG TABLET / ORAL AB 2017-05-25 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A203281-003 OLMESARTAN MEDOXOMIL 40MG TABLET / ORAL AB 2017-05-25 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A203281-001 OLMESARTAN MEDOXOMIL 5MG TABLET / ORAL AB 2017-05-25 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A203281-002 OLMESARTAN MEDOXOMIL 20MG TABLET / ORAL AB 2017-05-25 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A203281-003 OLMESARTAN MEDOXOMIL 40MG TABLET / ORAL AB 2017-05-25 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A203281-001 OLMESARTAN MEDOXOMIL 5MG TABLET / ORAL AB 2017-05-25 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A203281-002 OLMESARTAN MEDOXOMIL 20MG TABLET / ORAL AB 2017-05-25 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A203281-003 OLMESARTAN MEDOXOMIL 40MG TABLET / ORAL AB 2017-05-25 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A203281-001 OLMESARTAN MEDOXOMIL 5MG TABLET / ORAL AB 2017-05-25 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A203281-002 OLMESARTAN MEDOXOMIL 20MG TABLET / ORAL AB 2017-05-25 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A203281-003 OLMESARTAN MEDOXOMIL 40MG TABLET / ORAL AB 2017-05-25 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A203281-001 OLMESARTAN MEDOXOMIL 5MG TABLET / ORAL AB 2017-05-25 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A203281-002 OLMESARTAN MEDOXOMIL 20MG TABLET / ORAL AB 2017-05-25 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A203281-003 OLMESARTAN MEDOXOMIL 40MG TABLET / ORAL AB 2017-05-25 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A203281-001 OLMESARTAN MEDOXOMIL 5MG TABLET / ORAL AB 2017-05-25 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 2027-12-31 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# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 50090-4451-0 Olmesartan Medoxomil 30 in 1 BOTTLE TABLET, FILM COATED 30 7 50090-4451-1 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 50090-4451 OLMESARTAN MEDOXOMIL TABLET, FILM COATED [A-S MEDICATION SOLUTIONS] 5 Current NDC, Legacy NDC, 2 package rows 20210417_67aa498d-edf6-45b8-a3fd-019c3fb76960.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 · 5 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Olmesartan Medoxomil OLMESARTAN MEDOXOMIL A-S Medication Solutions 5972c6fd-08e3-4189-a894-1ba220b57e80 2026-05-27 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 203281 application number: ANDA203281 Olmesartan Medoxomil OLMESARTAN MEDOXOMIL Bryant Ranch Prepack 57dc737b-01e2-4b22-991f-d4710950dcf3 2026-05-13 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 203281 application number: ANDA203281 Olmesartan Medoxomil OLMESARTAN MEDOXOMIL A-S Medication Solutions 67aa498d-edf6-45b8-a3fd-019c3fb76960 2026-04-16 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 203281 application number: ANDA203281 ndc (product): 50090-4451 Olmesartan Medoxomil OLMESARTAN MEDOXOMIL A-S Medication Solutions 8acdc142-aa38-4fcb-bd15-fbba9635a4c6 2026-04-16 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 203281 application number: ANDA203281 Olmesartan Medoxomil OLMESARTAN MEDOXOMIL Glenmark Pharmaceuticals Inc., USA 8e0adf3d-7569-4909-bab1-5fed9578ad77 2026-01-30 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 203281 application number: ANDA203281
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 50090-4451-0 50090445100 30 TABLET, FILM COATED in 1 BOTTLE (50090-4451-0) 2019-08-05 0000-00-00 No No Current 50090-4451-1 50090445101 90 TABLET, FILM COATED in 1 BOTTLE (50090-4451-1) 2019-08-05 0000-00-00 No No Current