EDECRIN
TABLETS and INTRAVENOUS
Approved
Approval ID
1efe378e-fee1-4ae9-8ea5-0fe2265fe2d8
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 31, 2020
Manufacturers
FDA
Bausch Health US, LLC
DUNS: 831922468
Products 2
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 Code25010-215
Application NumberNDA016092
Product Classification
M
Marketing Category
C73594
G
Generic Name
ethacrynic acid
Product Specifications
Route of AdministrationORAL
Effective DateAugust 31, 2020
FDA Product Classification
INGREDIENTS (5)
ethacrynic acidActive
Quantity: 25 mg in 1 1
Code: M5DP350VZV
Classification: ACTIB
Silicon DioxideInactive
Code: ETJ7Z6XBU4
Classification: IACT
Magnesium StearateInactive
Code: 70097M6I30
Classification: IACT
TalcInactive
Code: 7SEV7J4R1U
Classification: IACT
LACTOSE, UNSPECIFIED FORMInactive
Code: J2B2A4N98G
Classification: IACT
ethacrynate sodium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code25010-210
Application NumberNDA016093
Product Classification
M
Marketing Category
C73594
G
Generic Name
ethacrynate sodium
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateAugust 31, 2020
FDA Product Classification
INGREDIENTS (2)
MANNITOLInactive
Quantity: 62.5 mg in 50 mL
Code: 3OWL53L36A
Classification: IACT
ETHACRYNATE SODIUMActive
Quantity: 50 mg in 50 mL
Code: K41MYV7MPM
Classification: ACTIM