FDA.reportPublic FDA data

olmesartan medoxomil

Product NDC
70518-4053
11-digit product format
705184053
Labeler code
70518
Product ID
70518-4053_3fa20044-d4cd-ebda-e063-6294a90af1a2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
olmesartan medoxomil
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA208130
Marketing category
ANDA
Marketing start
2024-04-16
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

Additional Listing Data#

Finished product
Yes
Brand name base
olmesartan medoxomil
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OLMESARTAN MEDOXOMIL40 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6M97XTV3HD
Rxcui349405

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c19ec24d-2c40-4b8d-7c20-500ffa3660a1Product name320260303
96816964-c075-ffa7-b7b8-d8570411a3b9Product name720250305
caadbc51-b731-1a7b-b91a-f7bb4a62554eProduct name920240306
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
4a27501f-a987-48a5-99b4-e983d4744d76Product name720181211

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70518-4053-0olmesartan medoxomil90 in 1 BOTTLE, PLASTICTABLET, FILM COATED904
70518-4053-1olmesartan medoxomil100 in 1 BOTTLE, PLASTICTABLET, FILM COATED1004
70518-4053-2olmesartan medoxomil60 in 1 BOTTLE, PLASTICTABLET, FILM COATED604

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-4053OLMESARTAN MEDOXOMIL TABLET, FILM COATED [REMEDYREPACK INC.]3Current NDC, 3 package rows20250508_1be698df-30a0-4117-8c24-7253af94c8ad.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349405olmesartan medoxomil 40 MG Oral TabletPSN1be698df-30a0-4117-8c24-7253af94c8ad4
349405olmesartan medoxomil 40 MG Oral TabletSCD1be698df-30a0-4117-8c24-7253af94c8ad4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
70518-4053-07051840530090 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-4053-0) 2024-04-16NoNoCurrent
70518-4053-170518405301100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-4053-1) 2025-03-20NoNoCurrent
70518-4053-27051840530260 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-4053-2) 2025-05-06NoNoCurrent