Perindopril Erbumine
Perindopril Erbumine Tablets 2 mg, 4 mg and 8 mg
Approved
Approval ID
fbb31482-9ac8-48c6-b814-5d467f22051b
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 1, 2010
Manufacturers
FDA
Lupin Pharmaceuticals, Inc
DUNS: 089153071
Products 3
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 Code68180-236
Application NumberANDA078263
Product Classification
M
Marketing Category
C73584
G
Generic Name
Perindopril Erbumine
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 26, 2010
FDA Product Classification
INGREDIENTS (5)
PERINDOPRIL ERBUMINEActive
Quantity: 4 mg in 1 1
Code: 1964X464OJ
Classification: ACTIB
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
Perindopril Erbumine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code68180-235
Application NumberANDA078263
Product Classification
M
Marketing Category
C73584
G
Generic Name
Perindopril Erbumine
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 26, 2010
FDA Product Classification
INGREDIENTS (5)
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
PERINDOPRIL ERBUMINEActive
Quantity: 2 mg in 1 1
Code: 1964X464OJ
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
Perindopril Erbumine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code68180-237
Application NumberANDA078263
Product Classification
M
Marketing Category
C73584
G
Generic Name
Perindopril Erbumine
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 26, 2010
FDA Product Classification
INGREDIENTS (5)
PERINDOPRIL ERBUMINEActive
Quantity: 8 mg in 1 1
Code: 1964X464OJ
Classification: ACTIB
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT