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ethacrynic sodium

TABLETS ETHACRYNIC ACID and INTRAVENOUS ETHACRYNATE SODIUM

Approved
Approval ID

f127598f-e6b3-4c35-800f-76e4217595ae

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Aug 31, 2023

Manufacturers
FDA

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

NDC Product Code68682-011
Application NumberNDA016092
Marketing CategoryC73605
Route of AdministrationORAL
Effective DateAugust 31, 2023
Generic Nameethacrynic acid

INGREDIENTS (5)

LACTOSE, UNSPECIFIED FORMInactive
Code: J2B2A4N98G
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
ETHACRYNIC ACIDActive
Quantity: 25 mg in 1 1
Code: M5DP350VZV
Classification: ACTIB

ethacrynic sodium

PRODUCT DETAILS

NDC Product Code68682-012
Application NumberNDA016093
Marketing CategoryC73605
Route of AdministrationINTRAVENOUS
Effective DateAugust 31, 2023
Generic Nameethacrynic sodium

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

Drug Labeling Information

HOW SUPPLIED SECTION

LOINC: 34069-5Updated: 8/31/2020

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

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ethacrynic sodium - FDA Drug Approval Details