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EDECRIN

TABLETS EDECRIN (ETHACRYNIC ACID) and INTRAVENOUS SODIUM EDECRIN (ETHACRYNATE SODIUM)

Approved
Approval ID

cfc43a98-2dc4-4edc-ad49-d2e368ea1bc2

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Dec 10, 2015

Manufacturers
FDA

Avera McKennan Hospital

DUNS: 068647668

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 Code69189-0371
Application NumberNDA016092
Product Classification
M
Marketing Category
C73594
G
Generic Name
ethacrynic acid
Product Specifications
Route of AdministrationORAL
Effective DateDecember 10, 2015
FDA Product Classification

INGREDIENTS (5)

ethacrynic acidActive
Quantity: 25 mg in 1 1
Code: M5DP350VZV
Classification: ACTIB
Silicon DioxideInactive
Code: ETJ7Z6XBU4
Classification: IACT
LactoseInactive
Code: J2B2A4N98G
Classification: IACT
Magnesium StearateInactive
Code: 70097M6I30
Classification: IACT
TalcInactive
Code: 7SEV7J4R1U
Classification: IACT

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EDECRIN - FDA Drug Approval Details