Ethacrynate Sodium
Ethacrynate Sodium for Injection, USP INTRAVENOUS
Approved
Approval ID
2939538d-703d-40c3-8a08-83885a48a088
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 17, 2022
Manufacturers
FDA
Zydus Lifesciences Limited
DUNS: 918596198
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Ethacrynate Sodium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code70771-1106
Application NumberANDA207758
Product Classification
M
Marketing Category
C73584
G
Generic Name
Ethacrynate Sodium
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateOctober 17, 2022
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