FDA.reportPublic FDA data

Olmesartan Medoxomil

Product NDC
67877-445
11-digit product format
678770445
Labeler code
67877
Product ID
67877-445_a1d66aa9-d0fa-4d21-bba0-ff8078c2e5af
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Olmesartan Medoxomil
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Ascend Laboratories, LLC
Application
ANDA206763
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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
4a27501f-a987-48a5-99b4-e983d4744d76Product name720181211

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67877-445-05Olmesartan Medoxomil500 in 1 BOTTLETABLET, COATED5009
67877-445-10Olmesartan Medoxomil1000 in 1 BOTTLETABLET, COATED10009
67877-445-30Olmesartan Medoxomil30 in 1 BOTTLETABLET, COATED309
67877-445-90Olmesartan Medoxomil90 in 1 BOTTLETABLET, COATED909

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67877-445-30EA - Each67877-445ab79bf1b-2ae2-4eaa-9773-ebeb231f0ca112017-05-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67877-445OLMESARTAN MEDOXOMIL TABLET, COATED [ASCEND LABORATORIES, LLC]8Current NDC, Legacy NDC, 4 package rows20220928_142b735a-e1cd-46e1-a523-3ef061001bf9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349401olmesartan medoxomil 20 MG Oral TabletPSN142b735a-e1cd-46e1-a523-3ef061001bf99
349405olmesartan medoxomil 40 MG Oral TabletPSN142b735a-e1cd-46e1-a523-3ef061001bf99
349373olmesartan medoxomil 5 MG Oral TabletPSN142b735a-e1cd-46e1-a523-3ef061001bf99
349401olmesartan medoxomil 20 MG Oral TabletSCD142b735a-e1cd-46e1-a523-3ef061001bf99
349405olmesartan medoxomil 40 MG Oral TabletSCD142b735a-e1cd-46e1-a523-3ef061001bf99
349373olmesartan medoxomil 5 MG Oral TabletSCD142b735a-e1cd-46e1-a523-3ef061001bf99
349373olmesartan medoxomil 5 MG Oral TabletPSNeff499eb-a0e4-4240-870c-83bb53434cc22
349373olmesartan medoxomil 5 MG Oral TabletSCDeff499eb-a0e4-4240-870c-83bb53434cc22

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
67877-445-0567877044505500 TABLET, COATED in 1 BOTTLE (67877-445-05) 2017-04-240000-00-00NoNoCurrent
67877-445-10678770445101000 TABLET, COATED in 1 BOTTLE (67877-445-10) 2017-04-240000-00-00NoNoCurrent
67877-445-306787704453030 TABLET, COATED in 1 BOTTLE (67877-445-30) 2017-04-240000-00-00NoNoCurrent
67877-445-906787704459090 TABLET, COATED in 1 BOTTLE (67877-445-90) 2017-04-240000-00-00NoNoCurrent