FDA.reportPublic FDA data

olmesartan medoxomil

Product NDC
71335-0775
11-digit product format
713350775
Labeler code
71335
Product ID
71335-0775_a8d88d67-a666-4e95-b00a-b81c24e52a52
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
olmesartan medoxomil
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA207662
Marketing category
ANDA
Marketing start
2017-04-27
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
71335-0775-1olmesartan medoxomil30 in 1 BOTTLETABLET, FILM COATED307
71335-0775-2olmesartan medoxomil60 in 1 BOTTLETABLET, FILM COATED607
71335-0775-3olmesartan medoxomil90 in 1 BOTTLETABLET, FILM COATED907
71335-0775-4olmesartan medoxomil180 in 1 BOTTLETABLET, FILM COATED1807

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-0775-1EA - Each71335-0775c1e7d93b-4a33-44b2-b9e0-7179cd61992c12022-10-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-0775OLMESARTAN MEDOXOMIL TABLET, FILM COATED [BRYANT RANCH PREPACK]7Current NDC, Legacy NDC, 4 package rows20240829_a4ceea38-8fff-4317-be04-8dc22222ec70.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349401olmesartan medoxomil 20 MG Oral TabletPSNa4ceea38-8fff-4317-be04-8dc22222ec707
349401olmesartan medoxomil 20 MG Oral TabletSCDa4ceea38-8fff-4317-be04-8dc22222ec707

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-0775-17133507750130 TABLET, FILM COATED in 1 BOTTLE (71335-0775-1) 2018-04-130000-00-00NoNoCurrent
71335-0775-27133507750260 TABLET, FILM COATED in 1 BOTTLE (71335-0775-2) 2018-08-080000-00-00NoNoCurrent
71335-0775-37133507750390 TABLET, FILM COATED in 1 BOTTLE (71335-0775-3) 2020-07-060000-00-00NoNoCurrent
71335-0775-471335077504180 TABLET, FILM COATED in 1 BOTTLE (71335-0775-4) 2021-12-270000-00-00NoNoCurrent