Ethacrynic Acid
Ethacrynic Acid Tablets USP
Approved
Approval ID
de7c25a6-ed00-4ef3-883d-f8841f5dbd02
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 19, 2021
Manufacturers
FDA
Edenbridge Pharmaceuticals LLC.
DUNS: 948715060
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 Code42799-405
Application NumberANDA205609
Product Classification
M
Marketing Category
C73584
G
Generic Name
Ethacrynic Acid
Product Specifications
Route of AdministrationORAL
Effective DateJuly 21, 2021
FDA Product Classification
INGREDIENTS (6)
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
ETHACRYNIC ACIDActive
Quantity: 25 mg in 1 1
Code: M5DP350VZV
Classification: ACTIB
CALCIUM STEARATEInactive
Code: 776XM7047L
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT