Perindopril Erbumine
These highlights do not include all the information needed to use Perindopril Erbumine Tablets safely and effectively. See full prescribing information for Perindopril Erbumine Tablets. Perindopril Erbumine 4 and 8 mg Tablets Initial U.S. Approval: 1993
Approved
Approval ID
fcaefca9-e6ca-4c97-9eb8-7f1c619ce4d0
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 28, 2015
Manufacturers
FDA
Marlex Pharmaceuticals Inc
DUNS: 782540215
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Perindopril Erbumine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code10135-599
Application NumberNDA020184
Product Classification
M
Marketing Category
C73594
G
Generic Name
Perindopril Erbumine
Product Specifications
Route of AdministrationORAL
Effective DateJune 4, 2015
FDA Product Classification
INGREDIENTS (6)
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
LACTOSEInactive
Code: J2B2A4N98G
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
PERINDOPRIL ERBUMINEActive
Quantity: 4 mg in 1 1
Code: 1964X464OJ
Classification: ACTIB
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
Perindopril Erbumine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code10135-600
Application NumberNDA020184
Product Classification
M
Marketing Category
C73594
G
Generic Name
Perindopril Erbumine
Product Specifications
Route of AdministrationORAL
Effective DateJune 4, 2015
FDA Product Classification
INGREDIENTS (6)
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
LACTOSEInactive
Code: J2B2A4N98G
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
PERINDOPRIL ERBUMINEActive
Quantity: 8 mg in 1 1
Code: 1964X464OJ
Classification: ACTIB
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT