olmesartan medoxomil

Product NDC
63629-8522
11-digit product format
636298522
Labeler code
63629
Product ID
63629-8522_63fab6d4-0622-40d9-ace7-3c125cd5dbe0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
olmesartan medoxomil
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
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
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
63629-8522-1olmesartan medoxomil90 in 1 BOTTLETABLET, FILM COATED90102

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-8522-1EA - Each63629-852246af14a5-cb92-441b-9bfc-02715399122312021-07-15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-8522OLMESARTAN MEDOXOMIL TABLET, FILM COATED [BRYANT RANCH PREPACK]102Current NDC, Legacy NDC, 1 package rows20240113_fe80fd21-fa8d-474e-ac0a-23f0e1eb7f3b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349401olmesartan medoxomil 20 MG Oral TabletPSNfe80fd21-fa8d-474e-ac0a-23f0e1eb7f3b102
349401olmesartan medoxomil 20 MG Oral TabletSCDfe80fd21-fa8d-474e-ac0a-23f0e1eb7f3b102

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63629-8522-16362985220190 TABLET, FILM COATED in 1 BOTTLE (63629-8522-1) 2021-05-190000-00-00NoNoCurrent