bumetanide
Rx only
Approved
Approval ID
a51d798c-5847-49b2-ba94-434131848199
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 21, 2020
Manufacturers
FDA
Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
DUNS: 780779901
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 Code14539-700
Application NumberANDA074225
Product Classification
M
Marketing Category
C73584
G
Generic Name
bumetanide
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 21, 2020
FDA Product Classification
INGREDIENTS (8)
BUMETANIDEActive
Quantity: 0.5 mg in 1 1
Code: 0Y2S3XUQ5H
Classification: ACTIB
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
bumetanide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code14539-702
Application NumberANDA074225
Product Classification
M
Marketing Category
C73584
G
Generic Name
bumetanide
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 21, 2020
FDA Product Classification
INGREDIENTS (7)
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
BUMETANIDEActive
Quantity: 2 mg in 1 1
Code: 0Y2S3XUQ5H
Classification: ACTIB
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
bumetanide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code14539-701
Application NumberANDA074225
Product Classification
M
Marketing Category
C73584
G
Generic Name
bumetanide
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 21, 2020
FDA Product Classification
INGREDIENTS (7)
BUMETANIDEActive
Quantity: 1 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
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT