FDA.reportPublic FDA data

Olmesartan medoxomil

Product NDC
33342-180
11-digit product format
333420180
Labeler code
33342
Product ID
33342-180_c9d7d145-3702-4b5c-9808-c9a52636858d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Olmesartan medoxomil
Dosage form
TABLET
Route
ORAL
Labeler
Macleods Pharmaceuticals Limited
Application
ANDA204814
Marketing category
ANDA
Marketing start
2017-04-25
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
2027-12-31

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
33342-180-07Olmesartan medoxomil30 in 1 BOTTLETABLET304
33342-180-10Olmesartan medoxomil90 in 1 BOTTLETABLET904
33342-180-12Olmesartan medoxomil10 in 1 BLISTER PACKTABLET104
33342-180-12Olmesartan medoxomil10 in 1 CARTONTABLET104
33342-180-44Olmesartan medoxomil1000 in 1 BOTTLETABLET10004

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
33342-180-07EA - Each33342-180f30da766-4262-4d7f-962d-57c580d0019812017-06-15
33342-180-10EA - Each33342-18049d2aca8-cc6f-4347-aff0-f3577a4a56ac12017-06-15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
33342-180OLMESARTAN MEDOXOMIL TABLET [MACLEODS PHARMACEUTICALS LIMITED]4Current NDC, Legacy NDC, 5 package rows20221122_24e308cc-7cec-4054-9627-66f743ed71b0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349405olmesartan medoxomil 40 MG Oral TabletPSN5f410909-a68a-4ada-963a-32018d37572f2
349405olmesartan medoxomil 40 MG Oral TabletSCD5f410909-a68a-4ada-963a-32018d37572f2
349405olmesartan medoxomil 40 MG Oral TabletPSN9d9f1c08-4f65-484c-943e-7e664281910f1
349405olmesartan medoxomil 40 MG Oral TabletSCD9d9f1c08-4f65-484c-943e-7e664281910f1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
33342-180-073334201800730 TABLET in 1 BOTTLE (33342-180-07) 30 tablet2017-04-250000-00-00NoNoCurrent
33342-180-103334201801090 TABLET in 1 BOTTLE (33342-180-10) 90 tablet2017-04-250000-00-00NoNoCurrent
33342-180-123334201801210 BLISTER PACK in 1 CARTON (33342-180-12) / 10 TABLET in 1 BLISTER PACK10 blister pack2017-04-250000-00-00NoNoCurrent
33342-180-44333420180441000 TABLET in 1 BOTTLE (33342-180-44) 1000 tablet2017-04-250000-00-00NoNoCurrent