FDA.reportPublic FDA data

OLMESARTAN MEDOXOMIL

Product NDC
64980-603
11-digit product format
649800603
Labeler code
64980
Product ID
64980-603_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
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
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
64980-603-03OLMESARTAN MEDOXOMIL30 in 1 BOTTLETABLET, COATED303
64980-603-09OLMESARTAN MEDOXOMIL90 in 1 BOTTLETABLET, COATED903

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64980-603OLMESARTAN 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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
64980-603-036498006030330 TABLET, COATED in 1 BOTTLE (64980-603-03) 2024-03-30NoNoCurrent
64980-603-096498006030990 TABLET, COATED in 1 BOTTLE (64980-603-09) 2024-03-30NoNoCurrent