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Bisoprolol Fumarate

Bisoprolol Fumarate Tablets USP

Approved
Approval ID

aca45d26-51c0-4257-9b5d-03e00e58196f

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Sep 23, 2011

Manufacturers
FDA

Carilion Materials Management

DUNS: 079239644

Products 1

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 Code68151-4504
Application NumberANDA078635
Product Classification
M
Marketing Category
C73584
G
Generic Name
Bisoprolol fumarate
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 23, 2011
FDA Product Classification

INGREDIENTS (13)

CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSInactive
Code: L11K75P92J
Classification: IACT
CROSPOVIDONEInactive
Code: 68401960MK
Classification: IACT
BISOPROLOL FUMARATEActive
Quantity: 5 mg in 1 1
Code: UR59KN573L
Classification: ACTIB
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
HYPROMELLOSE 2910 (5 MPA.S)Inactive
Code: R75537T0T4
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
POLYETHYLENE GLYCOL 6000Inactive
Code: 30IQX730WE
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT

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Bisoprolol Fumarate - FDA Drug Approval Details