Bisoprolol Fumarate
Bisoprolol Fumarate Tablets USP
Approved
Approval ID
d82243b9-3e56-4a2b-8750-cb95ec106885
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 10, 2010
Manufacturers
FDA
Rebel Distributors Corp
DUNS: 118802834
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Bisoprolol fumarate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code21695-667
Application NumberANDA078635
Product Classification
M
Marketing Category
C73584
G
Generic Name
Bisoprolol fumarate
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 15, 2009
FDA Product Classification
INGREDIENTS (13)
BISOPROLOL FUMARATEActive
Quantity: 5 mg in 1 1
Code: UR59KN573L
Classification: ACTIB
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
ANHYDROUS DIBASIC CALCIUM PHOSPHATEInactive
Code: L11K75P92J
Classification: IACT
CROSPOVIDONEInactive
Code: 68401960MK
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
HYPROMELLOSE 2910 (5 MPA.S)Inactive
Code: R75537T0T4
Classification: IACT
STARCH, PREGELATINIZED CORNInactive
Code: O8232NY3SJ
Classification: IACT
POLYETHYLENE GLYCOL 6000Inactive
Code: 30IQX730WE
Classification: IACT
COLLOIDAL SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
Bisoprolol fumarate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code21695-670
Application NumberANDA078635
Product Classification
M
Marketing Category
C73584
G
Generic Name
Bisoprolol fumarate
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 15, 2009
FDA Product Classification
INGREDIENTS (11)
BISOPROLOL FUMARATEActive
Quantity: 10 mg in 1 1
Code: UR59KN573L
Classification: ACTIB
ANHYDROUS DIBASIC CALCIUM PHOSPHATEInactive
Code: L11K75P92J
Classification: IACT
HYPROMELLOSE 2910 (5 MPA.S)Inactive
Code: R75537T0T4
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
CROSPOVIDONEInactive
Code: 68401960MK
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
COLLOIDAL SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
POLYETHYLENE GLYCOL 6000Inactive
Code: 30IQX730WE
Classification: IACT
STARCH, PREGELATINIZED CORNInactive
Code: O8232NY3SJ
Classification: IACT