FDA.reportPublic FDA data

olmesartan medoxomil

Product NDC
51407-198
11-digit product format
514070198
Labeler code
51407
Product ID
51407-198_44718755-5055-82a4-e063-6294a90a6f7b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
olmesartan medoxomil
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Golden State Medical Supply, Inc.
Application
ANDA208130
Marketing category
ANDA
Marketing start
2018-06-29
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
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
51407-198-30olmesartan medoxomil30 in 1 BOTTLETABLET, FILM COATED305
51407-198-90olmesartan medoxomil90 in 1 BOTTLETABLET, FILM COATED905

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51407-198-30EA - Each51407-1980a200494-1a22-4fb5-aca5-bfd3c2328ca712019-05-02
51407-198-90EA - Each51407-198d576a4e6-0c48-4b59-9e18-937fbd9825a212019-05-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51407-198OLMESARTAN MEDOXOMIL TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.]4Current NDC, Legacy NDC, 2 package rows20240616_865c2765-5072-d029-e053-2a91aa0a098e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
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
51407-198-305140701983030 TABLET, FILM COATED in 1 BOTTLE (51407-198-30) 2019-02-250000-00-00NoNoCurrent
51407-198-905140701989090 TABLET, FILM COATED in 1 BOTTLE (51407-198-90) 2019-02-250000-00-00NoNoCurrent