Ethacrynate Sodium

Product NDC
68382-246
11-digit product format
683820246
Labeler code
68382
Product ID
68382-246_8d05996d-e08d-415c-921c-0ad9b70dfbdd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ethacrynate Sodium
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Zydus Pharmaceuticals USA Inc.
Application
ANDA207758
Marketing category
ANDA
Marketing start
2018-01-24
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
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68382-246-01EA - Each68382-246ecd1a631-03c6-4cb2-b498-fbb49c24527412018-06-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68382-246ETHACRYNATE SODIUM INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [ZYDUS PHARMACEUTICALS USA INC.]2Legacy NDC20221118_db836794-dc0f-4109-9c27-6aaf391b3389.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68382-246-01683820246011 VIAL in 1 CARTON (68382-246-01) > 50 mL in 1 VIAL1 vial2018-01-240000-00-00NoNoCurrent