Levamlodipine
These highlights do not include all the information needed to use LEVAMLODIPINE TABLETS safely and effectively. See full prescribing information for LEVAMLODIPINE TABLETS. LEVAMLODIPINE TABLETS, for oral use. Initial U.S. Approval: 2019
Approved
Approval ID
664ea032-2dd4-41ef-8506-c453cba57144
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 18, 2021
Manufacturers
FDA
Xspire Pharma, LLC
DUNS: 078312042
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
levamlodipine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code42195-450
Application NumberNDA212895
Product Classification
M
Marketing Category
C73605
G
Generic Name
levamlodipine
Product Specifications
Route of AdministrationORAL
Effective DateNovember 18, 2021
FDA Product Classification
INGREDIENTS (5)
BETADEXInactive
Code: JV039JZZ3A
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
LEVAMLODIPINE MALEATEActive
Quantity: 5 mg in 1 1
Code: 12WW9T2ITA
Classification: ACTIB
levamlodipine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code42195-425
Application NumberNDA212895
Product Classification
M
Marketing Category
C73605
G
Generic Name
levamlodipine
Product Specifications
Route of AdministrationORAL
Effective DateNovember 18, 2021
FDA Product Classification
INGREDIENTS (5)
BETADEXInactive
Code: JV039JZZ3A
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
LEVAMLODIPINE MALEATEActive
Quantity: 2.5 mg in 1 1
Code: 12WW9T2ITA
Classification: ACTIB