Bisoprolol Fumarate
Bisoprolol Fumarate Tablets USP
Approved
Approval ID
4f11e64c-732e-419a-bc29-9cd2ff86d0b9
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 22, 2023
Manufacturers
FDA
Bryant Ranch Prepack
DUNS: 171714327
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 Code71335-2244
Application NumberANDA078635
Product Classification
M
Marketing Category
C73584
G
Generic Name
Bisoprolol fumarate
Product Specifications
Route of AdministrationORAL
Effective DateOctober 28, 2022
FDA Product Classification
INGREDIENTS (11)
POLYETHYLENE GLYCOL 6000Inactive
Code: 30IQX730WE
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
BISOPROLOL FUMARATEActive
Quantity: 10 mg in 1 1
Code: UR59KN573L
Classification: ACTIB
ANHYDROUS DIBASIC CALCIUM PHOSPHATEInactive
Code: L11K75P92J
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT
HYPROMELLOSE 2910 (5 MPA.S)Inactive
Code: R75537T0T4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT