Olmesartan Medoxomil

Product NDC
82009-075
11-digit product format
820090075
Labeler code
82009
Product ID
82009-075_477067c5-6637-417d-8b4d-5efb555272eb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Olmesartan Medoxomil
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
QUALLENT PHARMACEUTICALS HEALTH LLC
Application
ANDA204798
Marketing category
ANDA
Marketing start
2023-08-01
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
82009-075-90Olmesartan Medoxomil90 in 1 BOTTLETABLET, FILM COATED902

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82009-075OLMESARTAN MEDOXOMIL TABLET, FILM COATED [QUALLENT PHARMACEUTICALS HEALTH LLC]2Current NDC, 1 package rows20240523_98f930d5-f7c2-4870-92b4-0ad37ce45797.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349401olmesartan medoxomil 20 MG Oral TabletPSN98f930d5-f7c2-4870-92b4-0ad37ce457972
349405olmesartan medoxomil 40 MG Oral TabletPSN98f930d5-f7c2-4870-92b4-0ad37ce457972
349373olmesartan medoxomil 5 MG Oral TabletPSN98f930d5-f7c2-4870-92b4-0ad37ce457972
349401olmesartan medoxomil 20 MG Oral TabletSCD98f930d5-f7c2-4870-92b4-0ad37ce457972
349405olmesartan medoxomil 40 MG Oral TabletSCD98f930d5-f7c2-4870-92b4-0ad37ce457972
349373olmesartan medoxomil 5 MG Oral TabletSCD98f930d5-f7c2-4870-92b4-0ad37ce457972

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
82009-075-908200900759090 TABLET, FILM COATED in 1 BOTTLE (82009-075-90) 2023-08-01NoNoCurrent