Ethacrynic Sodium

Product NDC
67457-297
11-digit product format
674570297
Labeler code
67457
Product ID
67457-297_28d901ea-bf1b-4fb8-97f0-1365aec98875
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ethacrynic sodium
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Mylan Institutional LLC
Application
ANDA204634
Marketing category
ANDA
Marketing start
2016-08-31
Marketing end
0000-00-00
Substance
ETHACRYNATE SODIUM
Active strength
50 mg/50mL
Pharmacologic classes
Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67457-297-50EA - Each67457-297c2f4fb81-5f4d-4ace-ae5d-9f10ade71c2a12016-09-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67457-297ETHACRYNIC SODIUM INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MYLAN INSTITUTIONAL LLC]5Legacy NDC20250312_f108e431-f8d3-4442-8a60-bfc1d8a7bafc.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
67457-297-50674570297501 VIAL, SINGLE-DOSE in 1 CARTON (67457-297-50) > 50 mL in 1 VIAL, SINGLE-DOSE2016-08-310000-00-00NoNoCurrent