FDA.reportPublic FDA data

Olmesartan Medoxomil

Product NDC
65862-743
11-digit product format
658620743
Labeler code
65862
Product ID
65862-743_6135c8a8-0232-4aa1-be56-8c29a444d96f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Olmesartan Medoxomil
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Aurobindo Pharma Limited
Application
ANDA204798
Marketing category
ANDA
Marketing start
2017-04-24
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
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 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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
4a27501f-a987-48a5-99b4-e983d4744d76Product name720181211

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65862-743-01Olmesartan Medoxomil100 in 1 BOTTLETABLET, FILM COATED1009
65862-743-05Olmesartan Medoxomil500 in 1 BOTTLETABLET, FILM COATED5009
65862-743-10Olmesartan Medoxomil10 in 1 BLISTER PACKTABLET, FILM COATED109
65862-743-30Olmesartan Medoxomil30 in 1 BOTTLETABLET, FILM COATED309
65862-743-78Olmesartan Medoxomil10 in 1 CARTONTABLET, FILM COATED109
65862-743-90Olmesartan Medoxomil90 in 1 BOTTLETABLET, FILM COATED909
65862-743-99Olmesartan Medoxomil1000 in 1 BOTTLETABLET, FILM COATED10009

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65862-743-30EA - Each65862-743abd5dfcc-2f01-4cc7-8946-bede98b1f8ba12017-05-04
65862-743-90EA - Each65862-74315632fef-3b0c-4c1d-b9a2-6b2c454e4f4012017-05-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65862-743OLMESARTAN MEDOXOMIL TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]9Current NDC, Legacy NDC, 7 package rows20250108_8c94d403-809b-43b9-834f-3ecd330d2dd9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349405olmesartan medoxomil 40 MG Oral TabletPSN0a49d951-dd1b-413b-99e5-d3119267c46c102
349405olmesartan medoxomil 40 MG Oral TabletSCD0a49d951-dd1b-413b-99e5-d3119267c46c102
349401olmesartan medoxomil 20 MG Oral TabletPSN8c94d403-809b-43b9-834f-3ecd330d2dd99
349405olmesartan medoxomil 40 MG Oral TabletPSN8c94d403-809b-43b9-834f-3ecd330d2dd99
349373olmesartan medoxomil 5 MG Oral TabletPSN8c94d403-809b-43b9-834f-3ecd330d2dd99
349401olmesartan medoxomil 20 MG Oral TabletSCD8c94d403-809b-43b9-834f-3ecd330d2dd99
349405olmesartan medoxomil 40 MG Oral TabletSCD8c94d403-809b-43b9-834f-3ecd330d2dd99
349373olmesartan medoxomil 5 MG Oral TabletSCD8c94d403-809b-43b9-834f-3ecd330d2dd99
349401olmesartan medoxomil 20 MG Oral TabletPSNe210f962-9b91-46c6-af8f-9f9a9ae842452
349405olmesartan medoxomil 40 MG Oral TabletPSN16754802-d5a4-0350-e063-6394a90aa9672
349405olmesartan medoxomil 40 MG Oral TabletPSNe210f962-9b91-46c6-af8f-9f9a9ae842452
349401olmesartan medoxomil 20 MG Oral TabletSCDe210f962-9b91-46c6-af8f-9f9a9ae842452
349405olmesartan medoxomil 40 MG Oral TabletSCD16754802-d5a4-0350-e063-6394a90aa9672
349405olmesartan medoxomil 40 MG Oral TabletSCDe210f962-9b91-46c6-af8f-9f9a9ae842452

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65862-743-0165862074301100 TABLET, FILM COATED in 1 BOTTLE (65862-743-01) 2017-04-240000-00-00NoNoCurrent
65862-743-0565862074305500 TABLET, FILM COATED in 1 BOTTLE (65862-743-05) 2017-04-240000-00-00NoNoCurrent
65862-743-106586207431010 in 1 BLISTER PACKHistorical
65862-743-306586207433030 TABLET, FILM COATED in 1 BOTTLE (65862-743-30) 2017-04-240000-00-00NoNoCurrent
65862-743-786586207437810 BLISTER PACK in 1 CARTON (65862-743-78) / 10 TABLET, FILM COATED in 1 BLISTER PACK (65862-743-10) 10 blister pack2017-04-240000-00-00NoNoCurrent
65862-743-906586207439090 TABLET, FILM COATED in 1 BOTTLE (65862-743-90) 2017-04-240000-00-00NoNoCurrent
65862-743-99658620743991000 TABLET, FILM COATED in 1 BOTTLE (65862-743-99) 2017-04-240000-00-00NoNoCurrent