FDA.reportPublic FDA data

Olmesartan medoxomil

Product NDC
72205-165
11-digit product format
722050165
Labeler code
72205
Product ID
72205-165_c81a0bea-32c1-4a0a-ac3c-5afe99cecdf2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Olmesartan medoxomil
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Novadoz Pharmaceuticals LLC
Application
ANDA217399
Marketing category
ANDA
Marketing start
2023-01-18
Substance
OLMESARTAN MEDOXOMIL
Active strength
5 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 MEDOXOMIL5 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
72205-165-30Olmesartan medoxomil30 in 1 BOTTLETABLET, FILM COATED302
72205-165-66Olmesartan medoxomil1000 in 1 BOTTLETABLET, FILM COATED10002
72205-165-90Olmesartan medoxomil90 in 1 BOTTLETABLET, FILM COATED902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72205-165-30EA - Each72205-1652f4717f1-a3d1-4376-bfd7-a202628b6e8512024-08-12
72205-165-90EA - Each72205-165540a47f3-1490-446c-8336-8c1408b3cfd012024-08-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72205-165OLMESARTAN MEDOXOMIL TABLET, FILM COATED [NOVADOZ PHARMACEUTICALS LLC]2Current NDC, 3 package rows20240217_4238a064-1bfd-4ce3-b9d9-12c96eee8af0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349401olmesartan medoxomil 20 MG Oral TabletPSN4238a064-1bfd-4ce3-b9d9-12c96eee8af02
349405olmesartan medoxomil 40 MG Oral TabletPSN4238a064-1bfd-4ce3-b9d9-12c96eee8af02
349373olmesartan medoxomil 5 MG Oral TabletPSN4238a064-1bfd-4ce3-b9d9-12c96eee8af02
349401olmesartan medoxomil 20 MG Oral TabletSCD4238a064-1bfd-4ce3-b9d9-12c96eee8af02
349405olmesartan medoxomil 40 MG Oral TabletSCD4238a064-1bfd-4ce3-b9d9-12c96eee8af02
349373olmesartan medoxomil 5 MG Oral TabletSCD4238a064-1bfd-4ce3-b9d9-12c96eee8af02

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
72205-165-307220501653030 TABLET, FILM COATED in 1 BOTTLE (72205-165-30) 2023-12-18NoNoCurrent
72205-165-66722050165661000 TABLET, FILM COATED in 1 BOTTLE (72205-165-66) 2024-02-16NoNoCurrent
72205-165-907220501659090 TABLET, FILM COATED in 1 BOTTLE (72205-165-90) 2024-02-16NoNoCurrent