FDA.reportPublic FDA data

Olmesartan Medoxomil

Product NDC
68462-438
11-digit product format
684620438
Labeler code
68462
Product ID
68462-438_3d590efe-ccb3-4ca3-b49e-9547dd674eae
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Olmesartan Medoxomil
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Glenmark Pharmaceuticals Inc., USA
Application
ANDA203281
Marketing category
ANDA
Marketing start
2017-05-25
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Olmesartan Medoxomil
Listing expiration
2027-12-31

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
68462-438-10Olmesartan Medoxomil1000 in 1 BOTTLETABLET, FILM COATED10008
68462-438-11Olmesartan Medoxomil10 in 1 CARTONTABLET, FILM COATED108
68462-438-11Olmesartan Medoxomil10 in 1 BLISTER PACKTABLET, FILM COATED108
68462-438-30Olmesartan Medoxomil30 in 1 BOTTLETABLET, FILM COATED308
68462-438-90Olmesartan Medoxomil90 in 1 BOTTLETABLET, FILM COATED908

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68462-438-30EA - Each68462-43865cb1d55-051b-4504-9026-543362c8d89512017-06-15
68462-438-90EA - Each68462-438b0c6720b-7b1f-4483-906a-15002513ec3112017-06-15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68462-438OLMESARTAN MEDOXOMIL TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC., USA]7Current NDC, Legacy NDC, 5 package rows20230113_8e0adf3d-7569-4909-bab1-5fed9578ad77.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349401olmesartan medoxomil 20 MG Oral TabletPSN8e0adf3d-7569-4909-bab1-5fed9578ad778
349405olmesartan medoxomil 40 MG Oral TabletPSN8e0adf3d-7569-4909-bab1-5fed9578ad778
349373olmesartan medoxomil 5 MG Oral TabletPSN8e0adf3d-7569-4909-bab1-5fed9578ad778
349401olmesartan medoxomil 20 MG Oral TabletSCD8e0adf3d-7569-4909-bab1-5fed9578ad778
349405olmesartan medoxomil 40 MG Oral TabletSCD8e0adf3d-7569-4909-bab1-5fed9578ad778
349373olmesartan medoxomil 5 MG Oral TabletSCD8e0adf3d-7569-4909-bab1-5fed9578ad778
349405olmesartan medoxomil 40 MG Oral TabletPSN67aa498d-edf6-45b8-a3fd-019c3fb769607
349405olmesartan medoxomil 40 MG Oral TabletSCD67aa498d-edf6-45b8-a3fd-019c3fb769607
349405olmesartan medoxomil 40 MG Oral TabletPSN8acdc142-aa38-4fcb-bd15-fbba9635a4c63
349405olmesartan medoxomil 40 MG Oral TabletSCD8acdc142-aa38-4fcb-bd15-fbba9635a4c63

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68462-438-10684620438101000 TABLET, FILM COATED in 1 BOTTLE (68462-438-10) 2017-05-250000-00-00NoNoCurrent
68462-438-116846204381110 BLISTER PACK in 1 CARTON (68462-438-11) / 10 TABLET, FILM COATED in 1 BLISTER PACK10 blister pack2017-05-250000-00-00NoNoCurrent
68462-438-306846204383030 TABLET, FILM COATED in 1 BOTTLE (68462-438-30) 2017-05-250000-00-00NoNoCurrent
68462-438-906846204389090 TABLET, FILM COATED in 1 BOTTLE (68462-438-90) 2017-05-250000-00-00NoNoCurrent