olmesartan medoxomil

Product NDC
63629-9426
11-digit product format
636299426
Labeler code
63629
Product ID
63629-9426_2e1002ea-4cb7-45d6-b757-b25f6ea8c6e4
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
2018-02-16
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
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 MEDOXOMIL5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6M97XTV3HD
Rxcui349373

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
63629-9426-1olmesartan medoxomil90 in 1 BOTTLE, PLASTICTABLET, FILM COATED90104

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-9426OLMESARTAN MEDOXOMIL TABLET, FILM COATED [BRYANT RANCH PREPACK]103Current NDC, Legacy NDC, 1 package rows20240820_79e2620d-6554-4e03-8087-59ec2e4dd75b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349373olmesartan medoxomil 5 MG Oral TabletPSN79e2620d-6554-4e03-8087-59ec2e4dd75b104
349373olmesartan medoxomil 5 MG Oral TabletSCD79e2620d-6554-4e03-8087-59ec2e4dd75b104

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63629-9426-16362994260190 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (63629-9426-1) 2022-08-090000-00-00NoNoCurrent