FDA.reportPublic FDA data

SODIUM EDECRIN

Product NDC
25010-210
11-digit product format
250100210
Labeler code
25010
Product ID
25010-210_fc9fc557-cd95-4c2a-869e-68c0619fd35e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ethacrynate sodium
Dosage form
POWDER, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Bausch Health US, LLC
Application
NDA016093
Marketing category
NDA
Marketing start
1967-01-10
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
2021-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
93aead9c-5c26-5d19-73e9-d6c55a939061Product name920210525
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
01098bd8-4859-4cc2-9426-3489bf88d451Product name420201216
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
25010-210-27SODIUM EDECRIN50 mL in 1 VIALPOWDER, FOR SOLUTION5010
25010-210-27SODIUM EDECRIN1 in 1 CARTONPOWDER, FOR SOLUTION110

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
25010-210-27EA - Each25010-210f6cdc2a7-f838-4c08-b097-0bd4aa96407312013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ethacrynic acidACTIVE INGREDIENTM5DP350VZVEDECRIN (ETHACRYNIC ACID) TABLET [ATON PHARMA, INC.]2
ethacrynic acidACTIVE MOIETYM5DP350VZVEDECRIN (ETHACRYNIC ACID) TABLET [ATON PHARMA, INC.]2
LactoseINACTIVE INGREDIENTJ2B2A4N98GEDECRIN (ETHACRYNIC ACID) TABLET [ATON PHARMA, INC.]2
Magnesium StearateINACTIVE INGREDIENT70097M6I30EDECRIN (ETHACRYNIC ACID) TABLET [ATON PHARMA, INC.]2
Silicon DioxideINACTIVE INGREDIENTETJ7Z6XBU4EDECRIN (ETHACRYNIC ACID) TABLET [ATON PHARMA, INC.]2
TalcINACTIVE INGREDIENT7SEV7J4R1UEDECRIN (ETHACRYNIC ACID) TABLET [ATON PHARMA, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
25010-210EDECRIN (ETHACRYNIC ACID) TABLET SODIUM EDECRIN (ETHACRYNATE SODIUM) POWDER, FOR SOLUTION [BAUSCH HEALTH US, LLC]10Legacy NDC, 2 package rows20240806_1efe378e-fee1-4ae9-8ea5-0fe2265fe2d8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1251905Edecrin 25 MG Oral TabletPSN1efe378e-fee1-4ae9-8ea5-0fe2265fe2d810
211509Edecrin Sodium 50 MG InjectionPSN1efe378e-fee1-4ae9-8ea5-0fe2265fe2d810
617325ethacrynate sodium 50 MG InjectionPSN1efe378e-fee1-4ae9-8ea5-0fe2265fe2d810
1251903ethacrynic acid 25 MG Oral TabletPSN1efe378e-fee1-4ae9-8ea5-0fe2265fe2d810
211509ethacrynate sodium 50 MG Injection [Edecrin]SBD1efe378e-fee1-4ae9-8ea5-0fe2265fe2d810
1251905ethacrynic acid 25 MG Oral Tablet [Edecrin]SBD1efe378e-fee1-4ae9-8ea5-0fe2265fe2d810
617325ethacrynate sodium 50 MG InjectionSCD1efe378e-fee1-4ae9-8ea5-0fe2265fe2d810
1251903ethacrynic acid 25 MG Oral TabletSCD1efe378e-fee1-4ae9-8ea5-0fe2265fe2d810
1251905Edecrin 25 MG Oral TabletSY1efe378e-fee1-4ae9-8ea5-0fe2265fe2d810
211509Edecrin 50 MG InjectionSY1efe378e-fee1-4ae9-8ea5-0fe2265fe2d810
211509Edecrin Sodium 50 MG (equivalent to ethacrynic acid 50 MG) InjectionSY1efe378e-fee1-4ae9-8ea5-0fe2265fe2d810
617325ethacrynate sodium 50 MG (equivalent to ethacrynic acid 50 MG) InjectionSY1efe378e-fee1-4ae9-8ea5-0fe2265fe2d810

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
25010-210-27250100210271 VIAL in 1 CARTON (25010-210-27) > 50 mL in 1 VIAL1 vial1967-01-100000-00-00NoNoCurrent