FDA.reportPublic FDA data

olmesartan medoxomil

Product NDC
16729-321
11-digit product format
167290321
Labeler code
16729
Product ID
16729-321_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
2017-04-27
Substance
OLMESARTAN MEDOXOMIL
Active strength
20 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 MEDOXOMIL20 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
16729-321-10olmesartan medoxomil30 in 1 BOTTLE, PLASTICTABLET, FILM COATED309
16729-321-15olmesartan medoxomil90 in 1 BOTTLE, PLASTICTABLET, FILM COATED909
16729-321-16olmesartan medoxomil500 in 1 BOTTLE, PLASTICTABLET, FILM COATED5009
16729-321-17olmesartan medoxomil1000 in 1 BOTTLE, PLASTICTABLET, FILM COATED10009
16729-321-45olmesartan medoxomil10 in 1 BLISTER PACKTABLET, FILM COATED109
16729-321-46olmesartan 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
16729-321-10EA - Each16729-321d1b3d3ec-be0d-4bdd-8ae2-484645b8f76612017-05-03
16729-321-15EA - Each16729-321e0daec77-c6b6-40ce-b831-b404d11ea4c812017-05-03
16729-321-17EA - Each16729-321a1cb3908-cd4c-4a7f-83dd-f217a6ddd4f012017-05-03

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16729-321OLMESARTAN 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
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
349401olmesartan medoxomil 20 MG Oral TabletPSNa4ceea38-8fff-4317-be04-8dc22222ec707
349401olmesartan medoxomil 20 MG Oral TabletPSNb55b6172-d986-4fd9-ba85-a8393c9089497
349401olmesartan medoxomil 20 MG Oral TabletSCDa4ceea38-8fff-4317-be04-8dc22222ec707
349401olmesartan medoxomil 20 MG Oral TabletSCDb55b6172-d986-4fd9-ba85-a8393c9089497
349401olmesartan medoxomil 20 MG Oral TabletPSNb57e47a5-43e0-d1c5-e053-2a95a90a2b074
349405olmesartan medoxomil 40 MG Oral TabletPSNb57e47a5-43e0-d1c5-e053-2a95a90a2b074
349401olmesartan medoxomil 20 MG Oral TabletSCDb57e47a5-43e0-d1c5-e053-2a95a90a2b074
349405olmesartan medoxomil 40 MG Oral TabletSCDb57e47a5-43e0-d1c5-e053-2a95a90a2b074
349401olmesartan medoxomil 20 MG Oral TabletPSN949e6bad-fcb2-42f2-b9c8-e5620ef5ccd51
349401olmesartan medoxomil 20 MG Oral TabletSCD949e6bad-fcb2-42f2-b9c8-e5620ef5ccd51

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
16729-321-101672903211030 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (16729-321-10) 2017-04-270000-00-00NoNoCurrent
16729-321-151672903211590 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (16729-321-15) 2017-04-270000-00-00NoNoCurrent
16729-321-1616729032116500 in 1 BOTTLE, PLASTICHistorical
16729-321-17167290321171000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (16729-321-17) 2017-04-270000-00-00NoNoCurrent
16729-321-451672903214510 in 1 BLISTER PACKHistorical
16729-321-4616729032146100 in 1 BOX, UNIT-DOSEHistorical