bumetanide
Bumetanide Tablets, USP Rx only
Approved
Approval ID
82eb62ca-c32b-4ff8-9f71-43219b240480
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 5, 2023
Manufacturers
FDA
Zydus Lifesciences Limited
DUNS: 918596198
Products 3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
bumetanide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code70771-1024
Application NumberANDA202900
Product Classification
M
Marketing Category
C73584
G
Generic Name
bumetanide
Product Specifications
Route of AdministrationORAL
Effective DateDecember 5, 2023
FDA Product Classification
INGREDIENTS (10)
BUMETANIDEActive
Quantity: 0.5 mg in 1 1
Code: 0Y2S3XUQ5H
Classification: ACTIB
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
bumetanide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code70771-1026
Application NumberANDA202900
Product Classification
M
Marketing Category
C73584
G
Generic Name
bumetanide
Product Specifications
Route of AdministrationORAL
Effective DateDecember 5, 2023
FDA Product Classification
INGREDIENTS (9)
BUMETANIDEActive
Quantity: 2 mg in 1 1
Code: 0Y2S3XUQ5H
Classification: ACTIB
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
bumetanide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code70771-1025
Application NumberANDA202900
Product Classification
M
Marketing Category
C73584
G
Generic Name
bumetanide
Product Specifications
Route of AdministrationORAL
Effective DateDecember 5, 2023
FDA Product Classification
INGREDIENTS (9)
BUMETANIDEActive
Quantity: 1 mg in 1 1
Code: 0Y2S3XUQ5H
Classification: ACTIB
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT