Bumetanide
Bumetanide Tablets, USP (0.5 mg, 1 mg and 2 mg) Rx Only
Approved
Approval ID
a29cf117-00d0-4948-b646-013c8791ea39
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 26, 2022
Manufacturers
FDA
Major Pharmaceuticals
DUNS: 191427277
Products 1
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 Code0904-7016
Application NumberANDA209724
Product Classification
M
Marketing Category
C73584
G
Generic Name
Bumetanide
Product Specifications
Route of AdministrationORAL
Effective DateJune 4, 2021
FDA Product Classification
INGREDIENTS (5)
BUMETANIDEActive
Quantity: 1 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
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT