FDA.reportPublic FDA data

OLMESARTAN MEDOXOMIL

Product NDC
64980-601
11-digit product format
649800601
Labeler code
64980
Product ID
64980-601_4e8b4338-7c4c-4af4-8658-660111a8b966
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
olmesartan medoxomil
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Rising Pharma Holdings, Inc.
Application
ANDA208659
Marketing category
ANDA
Marketing start
2024-03-30
Marketing end
2026-06-30
Substance
OLMESARTAN MEDOXOMIL
Active strength
5 mg/1
Pharmacologic classes
Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
OLMESARTAN MEDOXOMIL

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OLMESARTAN MEDOXOMIL5 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
64980-601-03OLMESARTAN MEDOXOMIL30 in 1 BOTTLETABLET, COATED303
64980-601-09OLMESARTAN MEDOXOMIL90 in 1 BOTTLETABLET, COATED903

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64980-601OLMESARTAN MEDOXOMIL TABLET, COATED [RISING PHARMA HOLDINGS, INC.]3Current NDC, 2 package rows20241019_b02ff20e-3f0e-43f4-a7b5-6ce56295d023.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349401olmesartan medoxomil 20 MG Oral TabletPSNb02ff20e-3f0e-43f4-a7b5-6ce56295d0233
349405olmesartan medoxomil 40 MG Oral TabletPSNb02ff20e-3f0e-43f4-a7b5-6ce56295d0233
349373olmesartan medoxomil 5 MG Oral TabletPSNb02ff20e-3f0e-43f4-a7b5-6ce56295d0233
349401olmesartan medoxomil 20 MG Oral TabletSCDb02ff20e-3f0e-43f4-a7b5-6ce56295d0233
349405olmesartan medoxomil 40 MG Oral TabletSCDb02ff20e-3f0e-43f4-a7b5-6ce56295d0233
349373olmesartan medoxomil 5 MG Oral TabletSCDb02ff20e-3f0e-43f4-a7b5-6ce56295d0233
349373olmesartan medoxomil 5 MG Oral TabletPSNecbb9e05-d590-423f-b530-141f617d5a931
349373olmesartan medoxomil 5 MG Oral TabletSCDecbb9e05-d590-423f-b530-141f617d5a931

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
64980-601-036498006010330 in 1 BOTTLEHistorical
64980-601-096498006010990 TABLET, COATED in 1 BOTTLE (64980-601-09) 2024-03-302026-06-30NoNoHistorical