bisoprolol fumarate and hydrochlorothiazide
Bisoprolol Fumarate and Hydrochlorothiazide Tablets
Approved
Approval ID
cf088009-203e-4d70-b56e-b4062cf3fcd8
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 19, 2023
Manufacturers
FDA
A-S Medication Solutions
DUNS: 830016429
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
bisoprolol fumarate and hydrochlorothiazide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code50090-6478
Application NumberNDA020186
Product Classification
M
Marketing Category
C73605
G
Generic Name
bisoprolol fumarate and hydrochlorothiazide
Product Specifications
Route of AdministrationORAL
Effective DateOctober 5, 2022
FDA Product Classification
INGREDIENTS (12)
BISOPROLOL FUMARATEActive
Quantity: 2.5 mg in 1 1
Code: UR59KN573L
Classification: ACTIB
ANHYDROUS DIBASIC CALCIUM PHOSPHATEInactive
Code: L11K75P92J
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
CROSPOVIDONE (15 MPA.S AT 5%)Inactive
Code: 68401960MK
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
HYDROCHLOROTHIAZIDEActive
Quantity: 6.25 mg in 1 1
Code: 0J48LPH2TH
Classification: ACTIB