FDA.reportPublic FDA data

Olmesartan Medoxomil

Product NDC
72189-558
11-digit product format
721890558
Labeler code
72189
Product ID
72189-558_2cc83fbd-3bda-a6e6-e063-6294a90a95a9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Olmesartan Medoxomil
Dosage form
TABLET
Route
ORAL
Labeler
Direct_rx
Application
ANDA206720
Marketing category
ANDA
Marketing start
2024-06-24
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
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
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
72189-558-30Olmesartan Medoxomil30 in 1 BOTTLETABLET302
72189-558-90Olmesartan Medoxomil90 in 1 BOTTLETABLET902

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72189-558OLMESARTAN MEDOXOMIL TABLET [DIRECT_RX]2Current NDC, 2 package rows20250130_1ba299e7-0651-c23b-e063-6294a90a0245.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349401olmesartan medoxomil 20 MG Oral TabletPSN1ba299e7-0651-c23b-e063-6294a90a02452
349401olmesartan medoxomil 20 MG Oral TabletSCD1ba299e7-0651-c23b-e063-6294a90a02452

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72189-558-307218905583030 TABLET in 1 BOTTLE (72189-558-30) 30 tablet2024-06-24NoNoCurrent
72189-558-907218905589090 TABLET in 1 BOTTLE (72189-558-90) 90 tablet2024-06-24NoNoCurrent