FDA.reportPublic FDA data

Olmesartan medoxomil

Product NDC
50090-6632
11-digit product format
500906632
Labeler code
50090
Product ID
50090-6632_29f0e71a-8c15-458a-9573-d645afd585e0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Olmesartan medoxomil
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA204814
Marketing category
ANDA
Marketing start
2017-04-25
Substance
OLMESARTAN MEDOXOMIL
Active strength
40 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 MEDOXOMIL40 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6M97XTV3HD
Rxcui349405

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
50090-6632-0Olmesartan medoxomil30 in 1 BOTTLETABLET302
50090-6632-1Olmesartan medoxomil90 in 1 BOTTLETABLET902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-6632-0EA - Each50090-663272d71141-34d2-406e-bd7f-09a6c0f2966912023-10-16
50090-6632-1EA - Each50090-6632e97ce59e-3332-49cd-abde-cad0efc8097612023-10-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-6632OLMESARTAN MEDOXOMIL TABLET [A-S MEDICATION SOLUTIONS]2Current NDC, 2 package rows20230912_5f410909-a68a-4ada-963a-32018d37572f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349405olmesartan medoxomil 40 MG Oral TabletPSN5f410909-a68a-4ada-963a-32018d37572f2
349405olmesartan medoxomil 40 MG Oral TabletSCD5f410909-a68a-4ada-963a-32018d37572f2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50090-6632-05009066320030 TABLET in 1 BOTTLE (50090-6632-0) 30 tablet2023-08-25NoNoCurrent
50090-6632-15009066320190 TABLET in 1 BOTTLE (50090-6632-1) 90 tablet2023-08-25NoNoCurrent