Olmesartan Medoxomil

Product NDC
46708-131
11-digit product format
467080131
Labeler code
46708
Product ID
46708-131_03dfb859-492b-4154-8fc7-dc4fa90cbf59
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Olmesartan Medoxomil
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Alembic Pharmaceuticals Limited
Application
ANDA203012
Marketing category
ANDA
Marketing start
2017-04-24
Substance
OLMESARTAN MEDOXOMIL
Active strength
5 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 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
46708-131-10Olmesartan Medoxomil100 in 1 CARTONTABLET, FILM COATED1008
46708-131-30Olmesartan Medoxomil30 in 1 BOTTLETABLET, FILM COATED308
46708-131-90Olmesartan Medoxomil90 in 1 BOTTLETABLET, FILM COATED908
46708-131-91Olmesartan Medoxomil1000 in 1 BOTTLETABLET, FILM COATED10008

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
46708-131OLMESARTAN MEDOXOMIL TABLET, FILM COATED [ALEMBIC PHARMACEUTICALS LIMITED]8Current NDC, Legacy NDC, 4 package rows20230119_ac08ea7d-f529-42ca-850a-a0ecce7dc830.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349401olmesartan medoxomil 20 MG Oral TabletPSNac08ea7d-f529-42ca-850a-a0ecce7dc8308
349405olmesartan medoxomil 40 MG Oral TabletPSNac08ea7d-f529-42ca-850a-a0ecce7dc8308
349373olmesartan medoxomil 5 MG Oral TabletPSNac08ea7d-f529-42ca-850a-a0ecce7dc8308
349401olmesartan medoxomil 20 MG Oral TabletSCDac08ea7d-f529-42ca-850a-a0ecce7dc8308
349405olmesartan medoxomil 40 MG Oral TabletSCDac08ea7d-f529-42ca-850a-a0ecce7dc8308
349373olmesartan medoxomil 5 MG Oral TabletSCDac08ea7d-f529-42ca-850a-a0ecce7dc8308

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
46708-131-1046708013110100 TABLET, FILM COATED in 1 CARTON (46708-131-10) 2017-04-240000-00-00NoNoCurrent
46708-131-304670801313030 TABLET, FILM COATED in 1 BOTTLE (46708-131-30) 2017-04-240000-00-00NoNoCurrent
46708-131-904670801319090 TABLET, FILM COATED in 1 BOTTLE (46708-131-90) 2017-04-240000-00-00NoNoCurrent
46708-131-91467080131911000 TABLET, FILM COATED in 1 BOTTLE (46708-131-91) 2017-04-240000-00-00NoNoCurrent