FDA.reportPublic FDA data

OLMESARTAN MEDOXOMIL

Product NDC
42571-203
11-digit product format
425710203
Labeler code
42571
Product ID
42571-203_3619c2a8-fac7-3b89-e063-6294a90a7209
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
olmesartan medoxomil
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Micro Labs Limited
Application
ANDA206372
Marketing category
ANDA
Marketing start
2020-02-03
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
4a27501f-a987-48a5-99b4-e983d4744d76Product name720181211

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42571-203-05OLMESARTAN MEDOXOMIL500 in 1 BOTTLETABLET, FILM COATED5007
42571-203-10OLMESARTAN MEDOXOMIL1000 in 1 BOTTLETABLET, FILM COATED10007
42571-203-11OLMESARTAN MEDOXOMIL10 in 1 CARTONTABLET, FILM COATED107
42571-203-30OLMESARTAN MEDOXOMIL30 in 1 BOTTLETABLET, FILM COATED307
42571-203-32OLMESARTAN MEDOXOMIL10 in 1 BLISTER PACKTABLET, FILM COATED107
42571-203-90OLMESARTAN MEDOXOMIL90 in 1 BOTTLETABLET, FILM COATED907

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42571-203-30EA - Each42571-203dfbd7ff4-06fa-44b7-a86d-def937fc7bdc12021-12-08
42571-203-90EA - Each42571-203bd78b34f-b42b-46c9-959e-a1554876c86312021-12-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42571-203OLMESARTAN MEDOXOMIL TABLET, FILM COATED [MICRO LABS LIMITED]7Current NDC, Legacy NDC, 6 package rows20250529_de799a31-50ae-4b9e-a159-3d399b523dca.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349401olmesartan medoxomil 20 MG Oral TabletPSNde799a31-50ae-4b9e-a159-3d399b523dca7
349405olmesartan medoxomil 40 MG Oral TabletPSNde799a31-50ae-4b9e-a159-3d399b523dca7
349373olmesartan medoxomil 5 MG Oral TabletPSNde799a31-50ae-4b9e-a159-3d399b523dca7
349401olmesartan medoxomil 20 MG Oral TabletSCDde799a31-50ae-4b9e-a159-3d399b523dca7
349405olmesartan medoxomil 40 MG Oral TabletSCDde799a31-50ae-4b9e-a159-3d399b523dca7
349373olmesartan medoxomil 5 MG Oral TabletSCDde799a31-50ae-4b9e-a159-3d399b523dca7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
42571-203-0542571020305500 TABLET, FILM COATED in 1 BOTTLE (42571-203-05) 2020-02-030000-00-00NoNoCurrent
42571-203-10425710203101000 TABLET, FILM COATED in 1 BOTTLE (42571-203-10) 2020-02-030000-00-00NoNoCurrent
42571-203-114257102031110 BLISTER PACK in 1 CARTON (42571-203-11) / 10 TABLET, FILM COATED in 1 BLISTER PACK (42571-203-32) 10 blister pack2020-02-030000-00-00NoNoCurrent
42571-203-304257102033030 TABLET, FILM COATED in 1 BOTTLE (42571-203-30) 2020-02-030000-00-00NoNoCurrent
42571-203-324257102033210 in 1 BLISTER PACKHistorical
42571-203-904257102039090 TABLET, FILM COATED in 1 BOTTLE (42571-203-90) 2020-02-030000-00-00NoNoCurrent