OLMESARTAN MEDOXOMIL

Product NDC
0527-2425
11-digit product format
005272425
Labeler code
0527
Product ID
0527-2425_25a7ac1e-7dc4-3bb7-e063-6294a90ab8df
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Olmesartan medoxomil
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Lannett Company, Inc.
Application
ANDA211049
Marketing category
ANDA
Marketing start
2019-03-05
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
0527-2425-32OLMESARTAN MEDOXOMIL30 in 1 BOTTLE, PLASTICTABLET, FILM COATED308
0527-2425-46OLMESARTAN MEDOXOMIL90 in 1 BOTTLE, PLASTICTABLET, FILM COATED908

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0527-2425-32EA - Each0527-2425800a5458-277e-4d56-b5fb-92fc4c70d2b212021-11-09
0527-2425-46EA - Each0527-24259d175934-dd5e-43aa-aeef-824b29b80b5512021-11-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0527-2425OLMESARTAN MEDOXOMIL TABLET, FILM COATED [LANNETT COMPANY, INC.]8Current NDC, Legacy NDC, 2 package rows20241031_c620361a-dc2d-28a1-e053-2995a90abd14.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349401olmesartan medoxomil 20 MG Oral TabletPSNc620361a-dc2d-28a1-e053-2995a90abd148
349405olmesartan medoxomil 40 MG Oral TabletPSNc620361a-dc2d-28a1-e053-2995a90abd148
349373olmesartan medoxomil 5 MG Oral TabletPSNc620361a-dc2d-28a1-e053-2995a90abd148
349401olmesartan medoxomil 20 MG Oral TabletSCDc620361a-dc2d-28a1-e053-2995a90abd148
349405olmesartan medoxomil 40 MG Oral TabletSCDc620361a-dc2d-28a1-e053-2995a90abd148
349373olmesartan medoxomil 5 MG Oral TabletSCDc620361a-dc2d-28a1-e053-2995a90abd148

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0527-2425-320052724253230 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0527-2425-32) 2019-03-050000-00-00NoNoCurrent
0527-2425-460052724254690 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0527-2425-46) 2019-03-050000-00-00NoNoCurrent
0527-2425-520052724255230 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0527-2425-52) 2021-07-090000-00-00NoNoCurrent