ethacrynic sodium
TABLETS ETHACRYNIC ACID and INTRAVENOUS ETHACRYNATE SODIUM
f127598f-e6b3-4c35-800f-76e4217595ae
HUMAN PRESCRIPTION DRUG LABEL
Aug 31, 2023
Oceanside Pharmaceuticals
DUNS: 832011691
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
Product Classification
Product Specifications
INGREDIENTS (5)
ethacrynic sodium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
Product Classification
Product Specifications
INGREDIENTS (2)
Drug Labeling Information
HOW SUPPLIED SECTION
HOW SUPPLIED
Tablets Ethacrynic acid, 25 mg, are white, capsule shaped, scored tablets, coded VRX 205 on one side and EDECRIN on the other.
They are supplied as follows:
NDC 68682-011-10 in bottles of 100.
Intravenous Ethacrynate sodium is a dry white material either in a plug form or as a powder. It is supplied in vials containing ethacrynate sodium equivalent to 50 mg of ethacrynic acid.
NDC 68682-012-27
Storage
Store in a tightly closed container at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].
Tablets Ethacrynic acid
Distributed by:
Oceanside Pharmaceuticals, a division of
Bausch Health US, LLC
Bridgewater, NJ 08807 USA
Manufactured by:
Bausch Health Companies Inc.
Steinbach, MB R5G 1Z7, Canada
Intravenous Ethacrynate sodium
Distributed by:
Oceanside Pharmaceuticals, a division of
Bausch Health US, LLC
Bridgewater, NJ 08807 USA
Manufactured by:
Patheon Manufacturing Services LLC
Greenville, NC 27834 USA
© 2020 Bausch Health Companies Inc. or its affiliates
Rev. 08/2020
9627001 70015105