Home DailyMed 18f90bd4-cca2-4e70-845a-7021b818307e OLMESARTAN MEDOXOMIL TABLETS Drug label information. FDA.report displays public Structured Product Labeling data from DailyMed and legacy FDA.report DailyMed cache rows. This page is not medical advice, prescribing advice, or a substitute for the official label reviewed by a qualified healthcare professional. Labeling can change; when a current hydrated DailyMed SPL record is available, FDA.report shows that newer record before legacy cached files.
Manufacturer Zydus Lifesciences Limited
Effective date 2024-12-03
Label type HUMAN PRESCRIPTION DRUG LABEL
Version 5
Source legacy-cache
Hydrated at 2026-08-01 20:47:36 Label at a glance# Product olmesartan medoxomil
Active ingredient OLMESARTAN MEDOXOMIL
Label structure 1 sections
Products# Every source-derived product name is available through these pages.
DailyMed product names page 1 of 1 · 11 matching rows.
olmesartan medoxomil OLMESARTAN HYDROXYPROPYL CELLULOSE (1600000 WAMW) HYPROMELLOSES LACTOSE MONOHYDRATE HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED CELLULOSE, MICROCRYSTALLINE POLYETHYLENE GLYCOL, UNSPECIFIED TALC TITANIUM DIOXIDE STEARIC ACID NDC Codes# Product NDC, Package NDC table Product NDC Package NDC 70771-1059 70771-1059-3 , 70771-1059-9 , 70771-1059-1 , 70771-1059-5 , 70771-1059-0 , 70771-1059-2 , 70771-1059-7 70771-1060 70771-1060-3 , 70771-1060-9 , 70771-1060-1 , 70771-1060-5 , 70771-1060-0 , 70771-1060-2 , 70771-1060-7 70771-1061 70771-1061-3 , 70771-1061-9 , 70771-1061-1 , 70771-1061-5 , 70771-1061-0 , 70771-1061-2 , 70771-1061-7
Ingredients# Every source-derived ingredient row is available through these pages.
DailyMed ingredient rows page 1 of 1 · 30 matching rows.
Name, UNII, Kind table Name UNII Kind OLMESARTAN MEDOXOMIL 6M97XTV3HD ACTIB HYDROXYPROPYL CELLULOSE (1600000 WAMW) RFW2ET671P IACT HYPROMELLOSES 3NXW29V3WO IACT LACTOSE MONOHYDRATE EWQ57Q8I5X IACT HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED 2165RE0K14 IACT CELLULOSE, MICROCRYSTALLINE OP1R32D61U IACT POLYETHYLENE GLYCOL, UNSPECIFIED 3WJQ0SDW1A IACT TALC 7SEV7J4R1U IACT TITANIUM DIOXIDE 15FIX9V2JP IACT STEARIC ACID 4ELV7Z65AP IACT OLMESARTAN MEDOXOMIL 6M97XTV3HD ACTIB HYDROXYPROPYL CELLULOSE (1600000 WAMW) RFW2ET671P IACT HYPROMELLOSES 3NXW29V3WO IACT LACTOSE MONOHYDRATE EWQ57Q8I5X IACT HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED 2165RE0K14 IACT CELLULOSE, MICROCRYSTALLINE OP1R32D61U IACT POLYETHYLENE GLYCOL, UNSPECIFIED 3WJQ0SDW1A IACT TALC 7SEV7J4R1U IACT TITANIUM DIOXIDE 15FIX9V2JP IACT STEARIC ACID 4ELV7Z65AP IACT OLMESARTAN MEDOXOMIL 6M97XTV3HD ACTIB HYDROXYPROPYL CELLULOSE (1600000 WAMW) RFW2ET671P IACT HYPROMELLOSES 3NXW29V3WO IACT LACTOSE MONOHYDRATE EWQ57Q8I5X IACT HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED 2165RE0K14 IACT CELLULOSE, MICROCRYSTALLINE OP1R32D61U IACT POLYETHYLENE GLYCOL, UNSPECIFIED 3WJQ0SDW1A IACT TALC 7SEV7J4R1U IACT TITANIUM DIOXIDE 15FIX9V2JP IACT STEARIC ACID 4ELV7Z65AP IACT
Orange Book application contexts# All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.
Orange Book application contexts page 1 of 1 · 1 matching rows.
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
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 A205192-001 OLMESARTAN MEDOXOMIL OLMESARTAN MEDOXOMIL 5MG TABLET / ORAL AB 2017-04-24 A205192-002 OLMESARTAN MEDOXOMIL OLMESARTAN MEDOXOMIL 20MG TABLET / ORAL AB 2017-04-24 A205192-003 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 · 132 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 2026-10-15 13:18:30 2026-09 A205192-001 OLMESARTAN MEDOXOMIL 5MG TABLET / ORAL AB 2017-04-24 c2088c7a36db…2026-10-15 13:18:30 2026-09 A205192-002 OLMESARTAN MEDOXOMIL 20MG TABLET / ORAL AB 2017-04-24 c2088c7a36db…2026-10-15 13:18:30 2026-09 A205192-003 OLMESARTAN MEDOXOMIL 40MG TABLET / ORAL AB 2017-04-24 c2088c7a36db…2026-09-14 22:38:34 2026-08 A205192-001 OLMESARTAN MEDOXOMIL 5MG TABLET / ORAL AB 2017-04-24 84e616aacf4f…2026-09-14 22:38:34 2026-08 A205192-002 OLMESARTAN MEDOXOMIL 20MG TABLET / ORAL AB 2017-04-24 84e616aacf4f…2026-09-14 22:38:34 2026-08 A205192-003 OLMESARTAN MEDOXOMIL 40MG TABLET / ORAL AB 2017-04-24 84e616aacf4f…2026-08-18 06:07:40 2026-07 A205192-001 OLMESARTAN MEDOXOMIL 5MG TABLET / ORAL AB 2017-04-24 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A205192-002 OLMESARTAN MEDOXOMIL 20MG TABLET / ORAL AB 2017-04-24 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A205192-003 OLMESARTAN MEDOXOMIL 40MG TABLET / ORAL AB 2017-04-24 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A205192-001 OLMESARTAN MEDOXOMIL 5MG TABLET / ORAL AB 2017-04-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A205192-002 OLMESARTAN MEDOXOMIL 20MG TABLET / ORAL AB 2017-04-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A205192-003 OLMESARTAN MEDOXOMIL 40MG TABLET / ORAL AB 2017-04-24 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A205192-001 OLMESARTAN MEDOXOMIL 5MG TABLET / ORAL AB 2017-04-24 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A205192-002 OLMESARTAN MEDOXOMIL 20MG TABLET / ORAL AB 2017-04-24 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A205192-003 OLMESARTAN MEDOXOMIL 40MG TABLET / ORAL AB 2017-04-24 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A205192-001 OLMESARTAN MEDOXOMIL 5MG TABLET / ORAL AB 2017-04-24 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A205192-002 OLMESARTAN MEDOXOMIL 20MG TABLET / ORAL AB 2017-04-24 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A205192-003 OLMESARTAN MEDOXOMIL 40MG TABLET / ORAL AB 2017-04-24 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A205192-001 OLMESARTAN MEDOXOMIL 5MG TABLET / ORAL AB 2017-04-24 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A205192-002 OLMESARTAN MEDOXOMIL 20MG TABLET / ORAL AB 2017-04-24 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A205192-003 OLMESARTAN MEDOXOMIL 40MG TABLET / ORAL AB 2017-04-24 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A205192-001 OLMESARTAN MEDOXOMIL 5MG TABLET / ORAL AB 2017-04-24 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A205192-002 OLMESARTAN MEDOXOMIL 20MG TABLET / ORAL AB 2017-04-24 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A205192-003 OLMESARTAN MEDOXOMIL 40MG TABLET / ORAL AB 2017-04-24 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A205192-001 OLMESARTAN MEDOXOMIL 5MG TABLET / ORAL AB 2017-04-24 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A205192-002 OLMESARTAN MEDOXOMIL 20MG TABLET / ORAL AB 2017-04-24 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A205192-003 OLMESARTAN MEDOXOMIL 40MG TABLET / ORAL AB 2017-04-24 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A205192-001 OLMESARTAN MEDOXOMIL 5MG TABLET / ORAL AB 2017-04-24 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A205192-002 OLMESARTAN MEDOXOMIL 20MG TABLET / ORAL AB 2017-04-24 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A205192-003 OLMESARTAN MEDOXOMIL 40MG TABLET / ORAL AB 2017-04-24 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A205192-001 OLMESARTAN MEDOXOMIL 5MG TABLET / ORAL AB 2017-04-24 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A205192-002 OLMESARTAN MEDOXOMIL 20MG TABLET / ORAL AB 2017-04-24 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A205192-003 OLMESARTAN MEDOXOMIL 40MG TABLET / ORAL AB 2017-04-24 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A205192-001 OLMESARTAN MEDOXOMIL 5MG TABLET / ORAL AB 2017-04-24 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A205192-002 OLMESARTAN MEDOXOMIL 20MG TABLET / ORAL AB 2017-04-24 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A205192-003 OLMESARTAN MEDOXOMIL 40MG TABLET / ORAL AB 2017-04-24 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A205192-001 OLMESARTAN MEDOXOMIL 5MG TABLET / ORAL AB 2017-04-24 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A205192-002 OLMESARTAN MEDOXOMIL 20MG TABLET / ORAL AB 2017-04-24 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A205192-003 OLMESARTAN MEDOXOMIL 40MG TABLET / ORAL AB 2017-04-24 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A205192-001 OLMESARTAN MEDOXOMIL 5MG TABLET / ORAL AB 2017-04-24 79d66fd596c7…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 132 observed states.
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.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.