OLMESARTAN MEDOXOMIL

Product NDC
43547-301
11-digit product format
435470301
Labeler code
43547
Product ID
43547-301_21c26510-42e0-4e52-ae81-6c45713906ae
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
olmesartan medoxomil
Dosage form
TABLET
Route
ORAL
Labeler
Solco Healthcare US, LLC.
Application
ANDA206720
Marketing category
ANDA
Marketing start
2022-03-04
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
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
4a27501f-a987-48a5-99b4-e983d4744d76Product name720181211
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43547-301-03OLMESARTAN MEDOXOMIL30 in 1 BOTTLETABLET306
43547-301-09OLMESARTAN MEDOXOMIL90 in 1 BOTTLETABLET906
43547-301-50OLMESARTAN MEDOXOMIL500 in 1 BOTTLETABLET5006

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43547-301OLMESARTAN MEDOXOMIL TABLET [SOLCO HEALTHCARE US, LLC.]6Current NDC, Legacy NDC, 3 package rows20230113_6e602f81-1cc3-4ae1-8bdf-85572e35cf73.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349405olmesartan medoxomil 40 MG Oral TabletPSN2bb63404-7d54-4482-8377-6ff02052892a100
349405olmesartan medoxomil 40 MG Oral TabletSCD2bb63404-7d54-4482-8377-6ff02052892a100
349401olmesartan medoxomil 20 MG Oral TabletPSN6e602f81-1cc3-4ae1-8bdf-85572e35cf736
349405olmesartan medoxomil 40 MG Oral TabletPSN6e602f81-1cc3-4ae1-8bdf-85572e35cf736
349373olmesartan medoxomil 5 MG Oral TabletPSN6e602f81-1cc3-4ae1-8bdf-85572e35cf736
349401olmesartan medoxomil 20 MG Oral TabletSCD6e602f81-1cc3-4ae1-8bdf-85572e35cf736
349405olmesartan medoxomil 40 MG Oral TabletSCD6e602f81-1cc3-4ae1-8bdf-85572e35cf736
349373olmesartan medoxomil 5 MG Oral TabletSCD6e602f81-1cc3-4ae1-8bdf-85572e35cf736

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43547-301-034354703010330 TABLET in 1 BOTTLE (43547-301-03) 30 tablet2022-03-040000-00-00NoNoCurrent
43547-301-094354703010990 TABLET in 1 BOTTLE (43547-301-09) 90 tablet2022-03-040000-00-00NoNoCurrent
43547-301-5043547030150500 TABLET in 1 BOTTLE (43547-301-50) 500 tablet2022-03-040000-00-00NoNoCurrent