Levamlodipine

Product NDC
42195-450
11-digit product format
421950450
Labeler code
42195
Product ID
42195-450_d112ff93-0fa0-1774-e053-2995a90afaef
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
levamlodipine
Dosage form
TABLET
Route
ORAL
Labeler
Xspire Pharma, LLC
Application
NDA212895
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2021-08-15
Marketing end
0000-00-00
Substance
LEVAMLODIPINE MALEATE
Active strength
5 mg/1
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
99ce1bff-cadd-48bc-9910-990f58aed76bProduct name120200604

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42195-450-30Levamlodipine30 in 1 BOTTLETABLET301

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42195-450-30EA - Each42195-4504d05361d-043e-4a29-9dea-4c40ea45de0912022-05-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42195-450LEVAMLODIPINE TABLET [XSPIRE PHARMA, LLC]1Legacy NDC, 1 package rows20211119_664ea032-2dd4-41ef-8506-c453cba57144.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2377367levamlodipine 2.5 MG Oral TabletPSN664ea032-2dd4-41ef-8506-c453cba571441
2377371levamlodipine 5 MG Oral TabletPSN664ea032-2dd4-41ef-8506-c453cba571441
2377367levamlodipine 2.5 MG Oral TabletSCD664ea032-2dd4-41ef-8506-c453cba571441
2377371levamlodipine 5 MG Oral TabletSCD664ea032-2dd4-41ef-8506-c453cba571441
2377367levamlodipine 2.5 MG (equivalent to levamlodipine maleate 3.2 MG) Oral TabletSY664ea032-2dd4-41ef-8506-c453cba571441
2377371levamlodipine 5 MG (equivalent to levamlodipine maleate 6.4 MG) Oral TabletSY664ea032-2dd4-41ef-8506-c453cba571441

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
42195-450-304219504503030 TABLET in 1 BOTTLE (42195-450-30) 30 tablet2021-08-150000-00-00NoNoCurrent