Home NDC 71335-3162 Olmesartan medoxomil
Product NDC 71335-3162
11-digit product format 713353162
Labeler code 71335
Product ID 71335-3162_1b9ea11a-c9e8-448d-b999-ac81a1b11a5c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Olmesartan medoxomil
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Bryant Ranch Prepack
Application ANDA217399
Marketing category ANDA
Marketing start 2023-01-18
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 2027-12-31
Current FDA listing Yes 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 A217399-001 OLMESARTAN MEDOXOMIL OLMESARTAN MEDOXOMIL 5MG TABLET / ORAL AB 2023-01-18 A217399-002 OLMESARTAN MEDOXOMIL OLMESARTAN MEDOXOMIL 20MG TABLET / ORAL AB 2023-01-18 A217399-003 OLMESARTAN MEDOXOMIL OLMESARTAN MEDOXOMIL 40MG TABLET / ORAL AB 2023-01-18
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 2 · 78 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 A217399-001 OLMESARTAN MEDOXOMIL 5MG TABLET / ORAL AB 2023-01-18 c2088c7a36db…2026-10-15 13:18:30 2026-09 A217399-002 OLMESARTAN MEDOXOMIL 20MG TABLET / ORAL AB 2023-01-18 c2088c7a36db…2026-10-15 13:18:30 2026-09 A217399-003 OLMESARTAN MEDOXOMIL 40MG TABLET / ORAL AB 2023-01-18 c2088c7a36db…2026-09-14 22:38:34 2026-08 A217399-001 OLMESARTAN MEDOXOMIL 5MG TABLET / ORAL AB 2023-01-18 84e616aacf4f…2026-09-14 22:38:34 2026-08 A217399-002 OLMESARTAN MEDOXOMIL 20MG TABLET / ORAL AB 2023-01-18 84e616aacf4f…2026-09-14 22:38:34 2026-08 A217399-003 OLMESARTAN MEDOXOMIL 40MG TABLET / ORAL AB 2023-01-18 84e616aacf4f…2026-08-18 06:07:40 2026-07 A217399-001 OLMESARTAN MEDOXOMIL 5MG TABLET / ORAL AB 2023-01-18 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A217399-002 OLMESARTAN MEDOXOMIL 20MG TABLET / ORAL AB 2023-01-18 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A217399-003 OLMESARTAN MEDOXOMIL 40MG TABLET / ORAL AB 2023-01-18 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A217399-001 OLMESARTAN MEDOXOMIL 5MG TABLET / ORAL AB 2023-01-18 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A217399-002 OLMESARTAN MEDOXOMIL 20MG TABLET / ORAL AB 2023-01-18 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A217399-003 OLMESARTAN MEDOXOMIL 40MG TABLET / ORAL AB 2023-01-18 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A217399-001 OLMESARTAN MEDOXOMIL 5MG TABLET / ORAL AB 2023-01-18 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A217399-002 OLMESARTAN MEDOXOMIL 20MG TABLET / ORAL AB 2023-01-18 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A217399-003 OLMESARTAN MEDOXOMIL 40MG TABLET / ORAL AB 2023-01-18 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A217399-001 OLMESARTAN MEDOXOMIL 5MG TABLET / ORAL AB 2023-01-18 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A217399-002 OLMESARTAN MEDOXOMIL 20MG TABLET / ORAL AB 2023-01-18 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A217399-003 OLMESARTAN MEDOXOMIL 40MG TABLET / ORAL AB 2023-01-18 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A217399-001 OLMESARTAN MEDOXOMIL 5MG TABLET / ORAL AB 2023-01-18 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A217399-002 OLMESARTAN MEDOXOMIL 20MG TABLET / ORAL AB 2023-01-18 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A217399-003 OLMESARTAN MEDOXOMIL 40MG TABLET / ORAL AB 2023-01-18 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A217399-001 OLMESARTAN MEDOXOMIL 5MG TABLET / ORAL AB 2023-01-18 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A217399-002 OLMESARTAN MEDOXOMIL 20MG TABLET / ORAL AB 2023-01-18 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A217399-003 OLMESARTAN MEDOXOMIL 40MG TABLET / ORAL AB 2023-01-18 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A217399-001 OLMESARTAN MEDOXOMIL 5MG TABLET / ORAL AB 2023-01-18 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A217399-002 OLMESARTAN MEDOXOMIL 20MG TABLET / ORAL AB 2023-01-18 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A217399-003 OLMESARTAN MEDOXOMIL 40MG TABLET / ORAL AB 2023-01-18 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A217399-001 OLMESARTAN MEDOXOMIL 5MG TABLET / ORAL AB 2023-01-18 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A217399-002 OLMESARTAN MEDOXOMIL 20MG TABLET / ORAL AB 2023-01-18 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A217399-003 OLMESARTAN MEDOXOMIL 40MG TABLET / ORAL AB 2023-01-18 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A217399-001 OLMESARTAN MEDOXOMIL 5MG TABLET / ORAL AB 2023-01-18 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A217399-002 OLMESARTAN MEDOXOMIL 20MG TABLET / ORAL AB 2023-01-18 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A217399-003 OLMESARTAN MEDOXOMIL 40MG TABLET / ORAL AB 2023-01-18 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A217399-001 OLMESARTAN MEDOXOMIL 5MG TABLET / ORAL AB 2023-01-18 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A217399-002 OLMESARTAN MEDOXOMIL 20MG TABLET / ORAL AB 2023-01-18 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A217399-003 OLMESARTAN MEDOXOMIL 40MG TABLET / ORAL AB 2023-01-18 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A217399-001 OLMESARTAN MEDOXOMIL 5MG TABLET / ORAL AB 2023-01-18 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A217399-002 OLMESARTAN MEDOXOMIL 20MG TABLET / ORAL AB 2023-01-18 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A217399-003 OLMESARTAN MEDOXOMIL 40MG TABLET / ORAL AB 2023-01-18 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A217399-001 OLMESARTAN MEDOXOMIL 5MG TABLET / ORAL AB 2023-01-18 79d66fd596c7…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 78 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 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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 349373 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
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 · 2 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 71335-3162-1 71335316201 90 TABLET, FILM COATED in 1 BOTTLE (71335-3162-1) 2026-07-27 No No Current 71335-3162-2 71335316202 30 TABLET, FILM COATED in 1 BOTTLE (71335-3162-2) 2026-07-27 No No Current