FDA.reportPublic FDA data

Olmesartan Medoxomil

Product NDC
70518-1343
11-digit product format
705181343
Labeler code
70518
Product ID
70518-1343_5012362d-e9f8-ace7-e063-6294a90acb30
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Olmesartan Medoxomil
Dosage form
TABLET, COATED
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA206763
Marketing category
ANDA
Marketing start
2018-08-06
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Olmesartan Medoxomil
Listing expiration
2027-12-31

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
70518-1343-0Olmesartan Medoxomil90 in 1 BOTTLE, PLASTICTABLET, COATED9011
70518-1343-1Olmesartan Medoxomil100 in 1 BOTTLE, PLASTICTABLET, COATED10011

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-1343OLMESARTAN MEDOXOMIL TABLET, COATED [REMEDYREPACK INC.]7Current NDC, Legacy NDC, 2 package rows20250511_92969ed0-8dcd-4c6d-b0c4-e8469c2f65a9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349401olmesartan medoxomil 20 MG Oral TabletPSN92969ed0-8dcd-4c6d-b0c4-e8469c2f65a911
349401olmesartan medoxomil 20 MG Oral TabletSCD92969ed0-8dcd-4c6d-b0c4-e8469c2f65a911

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
70518-1343-07051813430090 TABLET, COATED in 1 BOTTLE, PLASTIC (70518-1343-0) 2018-08-06NoNoHistorical
70518-1343-170518134301100 TABLET, COATED in 1 BOTTLE, PLASTIC (70518-1343-1) 2026-04-22NoNoHistorical