Home NDC 46708-133 Olmesartan Medoxomil
Product NDC 46708-133
11-digit product format 467080133
Labeler code 46708
Product ID 46708-133_03dfb859-492b-4154-8fc7-dc4fa90cbf59
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Olmesartan Medoxomil
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Alembic Pharmaceuticals Limited
Application ANDA203012
Marketing category ANDA
Marketing start 2017-04-24
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 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 A203012-001 OLMESARTAN MEDOXOMIL OLMESARTAN MEDOXOMIL 5MG TABLET / ORAL AB 2017-04-24 A203012-002 OLMESARTAN MEDOXOMIL OLMESARTAN MEDOXOMIL 20MG TABLET / ORAL AB 2017-04-24 A203012-003 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 · 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 A203012-001 OLMESARTAN MEDOXOMIL 5MG TABLET / ORAL AB 2017-04-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A203012-002 OLMESARTAN MEDOXOMIL 20MG TABLET / ORAL AB 2017-04-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A203012-003 OLMESARTAN MEDOXOMIL 40MG TABLET / ORAL AB 2017-04-24 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203012-001 OLMESARTAN MEDOXOMIL 5MG TABLET / ORAL AB 2017-04-24 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203012-002 OLMESARTAN MEDOXOMIL 20MG TABLET / ORAL AB 2017-04-24 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203012-003 OLMESARTAN MEDOXOMIL 40MG TABLET / ORAL AB 2017-04-24 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A203012-001 OLMESARTAN MEDOXOMIL 5MG TABLET / ORAL AB 2017-04-24 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A203012-002 OLMESARTAN MEDOXOMIL 20MG TABLET / ORAL AB 2017-04-24 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A203012-003 OLMESARTAN MEDOXOMIL 40MG TABLET / ORAL AB 2017-04-24 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203012-001 OLMESARTAN MEDOXOMIL 5MG TABLET / ORAL AB 2017-04-24 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203012-002 OLMESARTAN MEDOXOMIL 20MG TABLET / ORAL AB 2017-04-24 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203012-003 OLMESARTAN MEDOXOMIL 40MG TABLET / ORAL AB 2017-04-24 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203012-001 OLMESARTAN MEDOXOMIL 5MG TABLET / ORAL AB 2017-04-24 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203012-002 OLMESARTAN MEDOXOMIL 20MG TABLET / ORAL AB 2017-04-24 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203012-003 OLMESARTAN MEDOXOMIL 40MG TABLET / ORAL AB 2017-04-24 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203012-001 OLMESARTAN MEDOXOMIL 5MG TABLET / ORAL AB 2017-04-24 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203012-002 OLMESARTAN MEDOXOMIL 20MG TABLET / ORAL AB 2017-04-24 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203012-003 OLMESARTAN MEDOXOMIL 40MG TABLET / ORAL AB 2017-04-24 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203012-001 OLMESARTAN MEDOXOMIL 5MG TABLET / ORAL AB 2017-04-24 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203012-002 OLMESARTAN MEDOXOMIL 20MG TABLET / ORAL AB 2017-04-24 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203012-003 OLMESARTAN MEDOXOMIL 40MG TABLET / ORAL AB 2017-04-24 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A203012-001 OLMESARTAN MEDOXOMIL 5MG TABLET / ORAL AB 2017-04-24 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A203012-002 OLMESARTAN MEDOXOMIL 20MG TABLET / ORAL AB 2017-04-24 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A203012-003 OLMESARTAN MEDOXOMIL 40MG TABLET / ORAL AB 2017-04-24 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A203012-001 OLMESARTAN MEDOXOMIL 5MG TABLET / ORAL AB 2017-04-24 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A203012-002 OLMESARTAN MEDOXOMIL 20MG TABLET / ORAL AB 2017-04-24 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A203012-003 OLMESARTAN MEDOXOMIL 40MG TABLET / ORAL AB 2017-04-24 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A203012-001 OLMESARTAN MEDOXOMIL 5MG TABLET / ORAL AB 2017-04-24 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A203012-002 OLMESARTAN MEDOXOMIL 20MG TABLET / ORAL AB 2017-04-24 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A203012-003 OLMESARTAN MEDOXOMIL 40MG TABLET / ORAL AB 2017-04-24 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A203012-001 OLMESARTAN MEDOXOMIL 5MG TABLET / ORAL AB 2017-04-24 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A203012-002 OLMESARTAN MEDOXOMIL 20MG TABLET / ORAL AB 2017-04-24 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A203012-003 OLMESARTAN MEDOXOMIL 40MG TABLET / ORAL AB 2017-04-24 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A203012-001 OLMESARTAN MEDOXOMIL 5MG TABLET / ORAL AB 2017-04-24 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A203012-002 OLMESARTAN MEDOXOMIL 20MG TABLET / ORAL AB 2017-04-24 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A203012-003 OLMESARTAN MEDOXOMIL 40MG TABLET / ORAL AB 2017-04-24 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A203012-001 OLMESARTAN MEDOXOMIL 5MG TABLET / ORAL AB 2017-04-24 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A203012-002 OLMESARTAN MEDOXOMIL 20MG TABLET / ORAL AB 2017-04-24 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A203012-003 OLMESARTAN MEDOXOMIL 40MG TABLET / ORAL AB 2017-04-24 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A203012-001 OLMESARTAN MEDOXOMIL 5MG TABLET / ORAL AB 2017-04-24 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 2026-12-31 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 46708-133-10 Olmesartan Medoxomil 100 in 1 CARTON TABLET, FILM COATED 100 8 46708-133-30 Olmesartan Medoxomil 30 in 1 BOTTLE TABLET, FILM COATED 30 8 46708-133-90 Olmesartan Medoxomil 90 in 1 BOTTLE TABLET, FILM COATED 90 8 46708-133-91 Olmesartan Medoxomil 1000 in 1 BOTTLE TABLET, FILM COATED 1000 8
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 46708-133 OLMESARTAN MEDOXOMIL TABLET, FILM COATED [ALEMBIC PHARMACEUTICALS LIMITED] 8 Current NDC, Legacy NDC, 4 package rows 20230119_ac08ea7d-f529-42ca-850a-a0ecce7dc830.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 · 2 matching rows.
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 46708-133-10 46708013310 100 TABLET, FILM COATED in 1 CARTON (46708-133-10) 2017-04-24 0000-00-00 No No Current 46708-133-30 46708013330 30 TABLET, FILM COATED in 1 BOTTLE (46708-133-30) 2017-04-24 0000-00-00 No No Current 46708-133-90 46708013390 90 TABLET, FILM COATED in 1 BOTTLE (46708-133-90) 2017-04-24 0000-00-00 No No Current 46708-133-91 46708013391 1000 TABLET, FILM COATED in 1 BOTTLE (46708-133-91) 2017-04-24 0000-00-00 No No Current