FDA.reportPublic FDA data

olmesartan medoxomil

Product NDC
16729-320
11-digit product format
167290320
Labeler code
16729
Product ID
16729-320_424dbf67-5be3-2810-e063-6294a90a3558
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
olmesartan medoxomil
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Accord Healthcare Inc.
Application
ANDA207662
Marketing category
ANDA
Marketing start
2018-02-16
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
16729-320-10olmesartan medoxomil30 in 1 BOTTLE, PLASTICTABLET, FILM COATED309
16729-320-15olmesartan medoxomil90 in 1 BOTTLE, PLASTICTABLET, FILM COATED909
16729-320-16olmesartan medoxomil500 in 1 BOTTLE, PLASTICTABLET, FILM COATED5009
16729-320-17olmesartan medoxomil1000 in 1 BOTTLE, PLASTICTABLET, FILM COATED10009
16729-320-45olmesartan medoxomil10 in 1 BLISTER PACKTABLET, FILM COATED109
16729-320-46olmesartan medoxomil100 in 1 BOX, UNIT-DOSETABLET, FILM COATED1009

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16729-320-10EA - Each16729-32079f1b1b5-a311-4b4d-a706-859d889325d012018-03-08
16729-320-15EA - Each16729-320123c0520-d135-433d-8fb5-45f1f9a183d012017-10-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16729-320OLMESARTAN MEDOXOMIL TABLET, FILM COATED [ACCORD HEALTHCARE INC.]8Current NDC, Legacy NDC, 6 package rows20240718_e5dbca00-4e1b-4479-b829-021b11bc021e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349373olmesartan medoxomil 5 MG Oral TabletPSN79e2620d-6554-4e03-8087-59ec2e4dd75b104
349373olmesartan medoxomil 5 MG Oral TabletSCD79e2620d-6554-4e03-8087-59ec2e4dd75b104
349401olmesartan medoxomil 20 MG Oral TabletPSNe5dbca00-4e1b-4479-b829-021b11bc021e9
349405olmesartan medoxomil 40 MG Oral TabletPSNe5dbca00-4e1b-4479-b829-021b11bc021e9
349373olmesartan medoxomil 5 MG Oral TabletPSNe5dbca00-4e1b-4479-b829-021b11bc021e9
349401olmesartan medoxomil 20 MG Oral TabletSCDe5dbca00-4e1b-4479-b829-021b11bc021e9
349405olmesartan medoxomil 40 MG Oral TabletSCDe5dbca00-4e1b-4479-b829-021b11bc021e9
349373olmesartan medoxomil 5 MG Oral TabletSCDe5dbca00-4e1b-4479-b829-021b11bc021e9
349373olmesartan medoxomil 5 MG Oral TabletPSNe64c3b3b-d5e7-6d46-e053-2a95a90a1b642
349373olmesartan medoxomil 5 MG Oral TabletSCDe64c3b3b-d5e7-6d46-e053-2a95a90a1b642

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
16729-320-101672903201030 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (16729-320-10) 2018-02-160000-00-00NoNoCurrent
16729-320-151672903201590 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (16729-320-15) 2018-02-160000-00-00NoNoCurrent
16729-320-1616729032016500 in 1 BOTTLE, PLASTICHistorical
16729-320-17167290320171000 in 1 BOTTLE, PLASTICHistorical
16729-320-451672903204510 in 1 BLISTER PACKHistorical
16729-320-4616729032046100 in 1 BOX, UNIT-DOSEHistorical