FDA.reportPublic FDA data

Olmesartan medoxomil

Product NDC
33342-179
11-digit product format
333420179
Labeler code
33342
Product ID
33342-179_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
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
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OLMESARTAN MEDOXOMIL20 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6M97XTV3HD

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
33342-179-07Olmesartan medoxomil30 in 1 BOTTLETABLET304
33342-179-10Olmesartan medoxomil90 in 1 BOTTLETABLET904
33342-179-12Olmesartan medoxomil10 in 1 BLISTER PACKTABLET104
33342-179-12Olmesartan medoxomil10 in 1 CARTONTABLET104
33342-179-44Olmesartan medoxomil1000 in 1 BOTTLETABLET10004

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
33342-179-07EA - Each33342-1793390320a-79c8-427e-8b01-7ff9208e0a2512017-06-15
33342-179-10EA - Each33342-1790aa82b6e-20c2-466c-811c-0f391d4417e612017-06-15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
33342-179OLMESARTAN 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
349401olmesartan medoxomil 20 MG Oral TabletPSN85a24657-583b-4776-98c9-b30285cb30581
349401olmesartan medoxomil 20 MG Oral TabletSCD85a24657-583b-4776-98c9-b30285cb30581

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
33342-179-073334201790730 TABLET in 1 BOTTLE (33342-179-07) 30 tablet2017-04-250000-00-00NoNoCurrent
33342-179-103334201791090 TABLET in 1 BOTTLE (33342-179-10) 90 tablet2017-04-250000-00-00NoNoCurrent
33342-179-123334201791210 BLISTER PACK in 1 CARTON (33342-179-12) / 10 TABLET in 1 BLISTER PACK10 blister pack2017-04-250000-00-00NoNoCurrent
33342-179-44333420179441000 TABLET in 1 BOTTLE (33342-179-44) 1000 tablet2017-04-250000-00-00NoNoCurrent