FDA.reportPublic FDA data

olmesartan medoxomil

Product NDC
59746-463
11-digit product format
597460463
Labeler code
59746
Product ID
59746-463_09a95078-de95-4c58-a910-4cd3b6f04810
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
olmesartan medoxomil
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Jubilant Cadista Pharmacuticals Inc.
Application
ANDA205482
Marketing category
ANDA
Marketing start
2016-04-01
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
59746-463-01olmesartan medoxomil100 in 1 BOTTLE, PLASTICTABLET, FILM COATED1006
59746-463-10olmesartan medoxomil1000 in 1 BOTTLE, PLASTICTABLET, FILM COATED10006
59746-463-30olmesartan medoxomil30 in 1 BOTTLE, PLASTICTABLET, FILM COATED306
59746-463-32olmesartan medoxomil3 in 1 CARTONTABLET, FILM COATED36
59746-463-32olmesartan medoxomil10 in 1 BLISTER PACKTABLET, FILM COATED106

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59746-463-30EA - Each59746-4639d16a716-6b72-48f5-9b05-e524fac1240d12017-06-15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59746-463OLMESARTAN MEDOXOMIL TABLET, FILM COATED [JUBILANT CADISTA PHARMACUTICALS INC.]6Current NDC, Legacy NDC, 5 package rows20250326_d5658d8a-f8e9-454d-89a9-34884e753001.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349401olmesartan medoxomil 20 MG Oral TabletPSNd5658d8a-f8e9-454d-89a9-34884e7530016
349405olmesartan medoxomil 40 MG Oral TabletPSNd5658d8a-f8e9-454d-89a9-34884e7530016
349373olmesartan medoxomil 5 MG Oral TabletPSNd5658d8a-f8e9-454d-89a9-34884e7530016
349401olmesartan medoxomil 20 MG Oral TabletSCDd5658d8a-f8e9-454d-89a9-34884e7530016
349405olmesartan medoxomil 40 MG Oral TabletSCDd5658d8a-f8e9-454d-89a9-34884e7530016
349373olmesartan medoxomil 5 MG Oral TabletSCDd5658d8a-f8e9-454d-89a9-34884e7530016

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
59746-463-0159746046301100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (59746-463-01) 2017-04-24NoNoHistorical
59746-463-10597460463101000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (59746-463-10) 2017-04-24NoNoHistorical
59746-463-305974604633030 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (59746-463-30) 2017-04-24NoNoHistorical
59746-463-32597460463323 BLISTER PACK in 1 CARTON (59746-463-32) / 10 TABLET, FILM COATED in 1 BLISTER PACK3 blister pack2017-04-24NoNoHistorical