Ethacrynic Acid
Ethacrynic Acid Tablets, USP (25 mg)
Approved
Approval ID
b9bc3907-bfa7-4d9f-90d9-c2097230f7e4
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 30, 2023
Manufacturers
FDA
Amneal Pharmaceuticals NY LLC
DUNS: 123797875
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Ethacrynic Acid
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code69238-1126
Application NumberANDA208805
Product Classification
M
Marketing Category
C73584
G
Generic Name
Ethacrynic Acid
Product Specifications
Route of AdministrationORAL
Effective DateDecember 30, 2023
FDA Product Classification
INGREDIENTS (5)
ETHACRYNIC ACIDActive
Quantity: 25 mg in 1 1
Code: M5DP350VZV
Classification: ACTIB
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT