Bumetanide
Bumetanide Tablets, USP Rx Only
Approved
Approval ID
9188ab17-8539-48a5-905f-ad35ab5a0b93
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 29, 2023
Manufacturers
FDA
Amneal Pharmaceuticals NY LLC
DUNS: 123797875
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 Code69238-1491
Application NumberANDA209724
Product Classification
M
Marketing Category
C73584
G
Generic Name
Bumetanide
Product Specifications
Route of AdministrationORAL
Effective DateDecember 29, 2023
FDA Product Classification
INGREDIENTS (5)
BUMETANIDEActive
Quantity: 2 mg in 1 1
Code: 0Y2S3XUQ5H
Classification: ACTIB
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
Bumetanide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code69238-1489
Application NumberANDA209724
Product Classification
M
Marketing Category
C73584
G
Generic Name
Bumetanide
Product Specifications
Route of AdministrationORAL
Effective DateDecember 29, 2023
FDA Product Classification
INGREDIENTS (5)
BUMETANIDEActive
Quantity: 0.5 mg in 1 1
Code: 0Y2S3XUQ5H
Classification: ACTIB
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
Bumetanide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code69238-1490
Application NumberANDA209724
Product Classification
M
Marketing Category
C73584
G
Generic Name
Bumetanide
Product Specifications
Route of AdministrationORAL
Effective DateDecember 29, 2023
FDA Product Classification
INGREDIENTS (5)
BUMETANIDEActive
Quantity: 1 mg in 1 1
Code: 0Y2S3XUQ5H
Classification: ACTIB
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT