Ethacrynic acid
Ethacrynic Acid Tablets USP
Approved
Approval ID
3b2b6ee1-1859-4b02-9ef2-5bbe6427f61a
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 7, 2023
Manufacturers
FDA
TRUPHARMA LLC
DUNS: 078533947
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 Code52817-367
Application NumberANDA211809
Product Classification
M
Marketing Category
C73584
G
Generic Name
Ethacrynic acid
Product Specifications
Route of AdministrationORAL
Effective DateDecember 7, 2023
FDA Product Classification
INGREDIENTS (4)
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