Ethacrynic Sodium
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Approved
Approval ID
f108e431-f8d3-4442-8a60-bfc1d8a7bafc
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 14, 2021
Manufacturers
FDA
Mylan Institutional LLC
DUNS: 790384502
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
ethacrynic sodium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code67457-297
Application NumberANDA204634
Product Classification
M
Marketing Category
C73584
G
Generic Name
ethacrynic sodium
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateJanuary 15, 2014
FDA Product Classification
INGREDIENTS (2)
ETHACRYNATE SODIUMActive
Quantity: 50 mg in 50 mL
Code: K41MYV7MPM
Classification: ACTIM
MANNITOLInactive
Quantity: 62.5 mg in 50 mL
Code: 3OWL53L36A
Classification: IACT