NDC 67457-297

Ethacrynic Sodium

Ethacrynic Sodium

Ethacrynic Sodium is a Intravenous Injection, Powder, Lyophilized, For Solution in the Human Prescription Drug category. It is labeled and distributed by Mylan Institutional Llc. The primary component is Ethacrynate Sodium.

• Product ID: 67457-297_28d901ea-bf1b-4fb8-97f0-1365aec98875
• NDC: 67457-297
• Product Type: Human Prescription Drug
• Proprietary Name: Ethacrynic Sodium
• Generic Name: Ethacrynic Sodium
• Dosage Form: Injection, Powder, Lyophilized, For Solution
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 2016-08-31
• Marketing Category: ANDA / ANDA
• Application Number: ANDA204634
• Labeler Name: Mylan Institutional LLC
• Substance Name: ETHACRYNATE SODIUM
• Active Ingredient Strength: 50 mg/50mL
• Pharm Classes: Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2022-12-31

Packaging

NDC 67457-297-50

1 VIAL, SINGLE-DOSE in 1 CARTON (67457-297-50) > 50 mL in 1 VIAL, SINGLE-DOSE

• Marketing Start Date: 2016-08-31
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 67457-297-50 [67457029750]

Ethacrynic Sodium INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

• Marketing Category: ANDA
• Application Number: ANDA204634
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2016-08-31

Drug Details

Active Ingredients

Ingredient	Strength
ETHACRYNATE SODIUM	50 mg/50mL

OpenFDA Data

• SPL SET ID: f108e431-f8d3-4442-8a60-bfc1d8a7bafc
• Manufacturer:
  • Mylan Institutional LLC
• UNII:
  • K41MYV7MPM
• RxNorm Concept Unique ID - RxCUI:
  • 617325

Pharmacological Class

• Increased Diuresis at Loop of Henle [PE]
• Loop Diuretic [EPC]
• Increased Diuresis at Loop of Henle [PE]
• Loop Diuretic [EPC]

NDC Crossover Matching brand name "Ethacrynic Sodium" or generic name "Ethacrynic Sodium"

NDC	Brand Name	Generic Name
67457-297	Ethacrynic Sodium	ethacrynic sodium
68682-012	ethacrynic sodium	ethacrynic sodium