Nadolol and Bendroflumethiazide
NADOLOL AND BENDROFLUMETHIAZIDE TABLETS, USP, 40 mg/5 mg AND 80 mg/5 mg
Approved
Approval ID
d2d226ea-1624-47ee-82bf-e9660b75029f
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 15, 2016
Manufacturers
FDA
Impax Generics
DUNS: 079832487
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
NADOLOL and BENDROFLUMETHIAZIDE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0115-5311
Application NumberANDA077833
Product Classification
M
Marketing Category
C73584
G
Generic Name
NADOLOL and BENDROFLUMETHIAZIDE
Product Specifications
Route of AdministrationORAL
Effective DateApril 15, 2016
FDA Product Classification
INGREDIENTS (10)
BENDROFLUMETHIAZIDEActive
Quantity: 5 mg in 1 1
Code: 5Q52X6ICJI
Classification: ACTIB
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
NADOLOLActive
Quantity: 40 mg in 1 1
Code: FEN504330V
Classification: ACTIB
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
NADOLOL and BENDROFLUMETHIAZIDE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0115-5322
Application NumberANDA077833
Product Classification
M
Marketing Category
C73584
G
Generic Name
NADOLOL and BENDROFLUMETHIAZIDE
Product Specifications
Route of AdministrationORAL
Effective DateApril 15, 2016
FDA Product Classification
INGREDIENTS (10)
BENDROFLUMETHIAZIDEActive
Quantity: 5 mg in 1 1
Code: 5Q52X6ICJI
Classification: ACTIB
NADOLOLActive
Quantity: 80 mg in 1 1
Code: FEN504330V
Classification: ACTIB
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT