Home NDC 68462-438 Olmesartan Medoxomil
Product NDC 68462-438
11-digit product format 684620438
Labeler code 68462
Product ID 68462-438_3d590efe-ccb3-4ca3-b49e-9547dd674eae
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Olmesartan Medoxomil
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Glenmark Pharmaceuticals Inc., USA
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 Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 · 129 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 2026-09-14 22:38:34 2026-08 A203281-001 OLMESARTAN MEDOXOMIL 5MG TABLET / ORAL AB 2017-05-25 84e616aacf4f…2026-09-14 22:38:34 2026-08 A203281-002 OLMESARTAN MEDOXOMIL 20MG TABLET / ORAL AB 2017-05-25 84e616aacf4f…2026-09-14 22:38:34 2026-08 A203281-003 OLMESARTAN MEDOXOMIL 40MG TABLET / ORAL AB 2017-05-25 84e616aacf4f…2026-08-18 06:07:40 2026-07 A203281-001 OLMESARTAN MEDOXOMIL 5MG TABLET / ORAL AB 2017-05-25 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A203281-002 OLMESARTAN MEDOXOMIL 20MG TABLET / ORAL AB 2017-05-25 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A203281-003 OLMESARTAN MEDOXOMIL 40MG TABLET / ORAL AB 2017-05-25 caaa826d4ba7…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…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 129 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
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 · 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 68462-438-10 Olmesartan Medoxomil 1000 in 1 BOTTLE TABLET, FILM COATED 1000 8 68462-438-11 Olmesartan Medoxomil 10 in 1 CARTON TABLET, FILM COATED 10 8 68462-438-11 Olmesartan Medoxomil 10 in 1 BLISTER PACK TABLET, FILM COATED 10 8 68462-438-30 Olmesartan Medoxomil 30 in 1 BOTTLE TABLET, FILM COATED 30 8 68462-438-90 Olmesartan Medoxomil 90 in 1 BOTTLE TABLET, FILM COATED 90 8
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68462-438 OLMESARTAN MEDOXOMIL TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC., USA] 7 Current NDC, Legacy NDC, 5 package rows 20230113_8e0adf3d-7569-4909-bab1-5fed9578ad77.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 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 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 ndc (product): 68462-438
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 68462-438-10 68462043810 1000 TABLET, FILM COATED in 1 BOTTLE (68462-438-10) 2017-05-25 0000-00-00 No No Current 68462-438-11 68462043811 10 BLISTER PACK in 1 CARTON (68462-438-11) / 10 TABLET, FILM COATED in 1 BLISTER PACK 10 blister pack 2017-05-25 0000-00-00 No No Current 68462-438-30 68462043830 30 TABLET, FILM COATED in 1 BOTTLE (68462-438-30) 2017-05-25 0000-00-00 No No Current 68462-438-90 68462043890 90 TABLET, FILM COATED in 1 BOTTLE (68462-438-90) 2017-05-25 0000-00-00 No No Current