FDA.reportPublic FDA data

olmesartan medoxomil

Product NDC
50228-339
11-digit product format
502280339
Labeler code
50228
Product ID
50228-339_b866b8df-72d9-2de9-e053-2995a90a3d70
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
olmesartan medoxomil
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
ScieGen Pharmaceuticals, Inc.
Application
ANDA208130
Marketing category
ANDA
Marketing start
2018-06-29
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
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 MEDOXOMIL5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6M97XTV3HD
Rxcui349373, 349401, 349405

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
50228-339-10olmesartan medoxomil1000 in 1 BOTTLETABLET, FILM COATED10008
50228-339-30olmesartan medoxomil30 in 1 BOTTLETABLET, FILM COATED308
50228-339-90olmesartan medoxomil90 in 1 BOTTLETABLET, FILM COATED908

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50228-339OLMESARTAN MEDOXOMIL TABLET, FILM COATED [SCIEGEN PHARMACEUTICALS, INC.]8Current NDC, Legacy NDC, 3 package rows20210109_f15664a4-6b5f-4e88-ad56-c827ed90a40c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349401olmesartan medoxomil 20 MG Oral TabletPSNf15664a4-6b5f-4e88-ad56-c827ed90a40c8
349405olmesartan medoxomil 40 MG Oral TabletPSNf15664a4-6b5f-4e88-ad56-c827ed90a40c8
349373olmesartan medoxomil 5 MG Oral TabletPSNf15664a4-6b5f-4e88-ad56-c827ed90a40c8
349401olmesartan medoxomil 20 MG Oral TabletSCDf15664a4-6b5f-4e88-ad56-c827ed90a40c8
349405olmesartan medoxomil 40 MG Oral TabletSCDf15664a4-6b5f-4e88-ad56-c827ed90a40c8
349373olmesartan medoxomil 5 MG Oral TabletSCDf15664a4-6b5f-4e88-ad56-c827ed90a40c8
349401olmesartan medoxomil 20 MG Oral TabletPSN865c2765-5072-d029-e053-2a91aa0a098e5
349405olmesartan medoxomil 40 MG Oral TabletPSN865c2765-5072-d029-e053-2a91aa0a098e5
349373olmesartan medoxomil 5 MG Oral TabletPSN865c2765-5072-d029-e053-2a91aa0a098e5
349401olmesartan medoxomil 20 MG Oral TabletSCD865c2765-5072-d029-e053-2a91aa0a098e5
349405olmesartan medoxomil 40 MG Oral TabletSCD865c2765-5072-d029-e053-2a91aa0a098e5
349373olmesartan medoxomil 5 MG Oral TabletSCD865c2765-5072-d029-e053-2a91aa0a098e5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50228-339-10502280339101000 TABLET, FILM COATED in 1 BOTTLE (50228-339-10) 2018-06-290000-00-00NoNoCurrent
50228-339-305022803393030 TABLET, FILM COATED in 1 BOTTLE (50228-339-30) 2018-06-290000-00-00NoNoCurrent
50228-339-905022803399090 TABLET, FILM COATED in 1 BOTTLE (50228-339-90) 2018-06-290000-00-00NoNoCurrent