olmesartan medoxomil

Product NDC
70518-4316
11-digit product format
705184316
Labeler code
70518
Product ID
70518-4316_402e3048-82b6-8323-e063-6294a90ace2b
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
2025-03-20
Substance
OLMESARTAN MEDOXOMIL
Active strength
20 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 MEDOXOMIL20 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6M97XTV3HD
Rxcui349401

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
4a27501f-a987-48a5-99b4-e983d4744d76Product name720181211

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70518-4316-0olmesartan medoxomil100 in 1 BOTTLE, PLASTICTABLET, FILM COATED1002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-4316OLMESARTAN MEDOXOMIL TABLET, FILM COATED [REMEDYREPACK INC.]1Current NDC, 1 package rows20250322_fe6e39da-fb6e-46da-9c03-c765020a7c87.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349401olmesartan medoxomil 20 MG Oral TabletPSNfe6e39da-fb6e-46da-9c03-c765020a7c872
349401olmesartan medoxomil 20 MG Oral TabletSCDfe6e39da-fb6e-46da-9c03-c765020a7c872

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
70518-4316-070518431600100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-4316-0) 2025-03-20NoNoHistorical