Ethacrynic Acid

Product NDC
50228-334
11-digit product format
502280334
Labeler code
50228
Product ID
50228-334_2a0ab1c4-a5f5-aeed-e063-6394a90a5992
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ethacrynic Acid
Dosage form
TABLET
Route
ORAL
Labeler
ScieGen Pharmaceuticals Inc
Application
ANDA211232
Marketing category
ANDA
Marketing start
2019-08-27
Substance
ETHACRYNIC ACID
Active strength
25 mg/1
Pharmacologic classes
Increased Diuresis at Loop of Henle [PE], Loop Diuretic [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Ethacrynic Acid
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ETHACRYNIC ACID25 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiM5DP350VZV
Rxcui1251903

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
93aead9c-5c26-5d19-73e9-d6c55a939061Product name920210525
01098bd8-4859-4cc2-9426-3489bf88d451Product name420201216

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50228-334-01Ethacrynic Acid1000 in 1 BOTTLETABLET10004
50228-334-10Ethacrynic Acid100 in 1 BOTTLETABLET1004
50228-334-30Ethacrynic Acid30 in 1 BOTTLETABLET304

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50228-334-10EA - Each50228-334881c38c5-17f4-42d6-9af1-f437af9c87ab12020-03-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50228-334ETHACRYNIC ACID TABLET [SCIEGEN PHARMACEUTICALS INC]4Current NDC, Legacy NDC, 3 package rows20241226_d400d264-c231-4bdf-8180-eb11ab4e9f29.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1251903ethacrynic acid 25 MG Oral TabletPSNfd1b7fb4-fe56-4f2d-860d-bbcea16adfea101
1251903ethacrynic acid 25 MG Oral TabletSCDfd1b7fb4-fe56-4f2d-860d-bbcea16adfea101
1251903ethacrynic acid 25 MG Oral TabletPSNd400d264-c231-4bdf-8180-eb11ab4e9f294
1251903ethacrynic acid 25 MG Oral TabletSCDd400d264-c231-4bdf-8180-eb11ab4e9f294
1251903ethacrynic acid 25 MG Oral TabletPSNf4e95ca1-502b-5305-e053-2995a90a5dc72
1251903ethacrynic acid 25 MG Oral TabletSCDf4e95ca1-502b-5305-e053-2995a90a5dc72

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50228-334-01502280334011000 TABLET in 1 BOTTLE (50228-334-01) 1000 tablet2019-08-270000-00-00NoNoCurrent
50228-334-1050228033410100 TABLET in 1 BOTTLE (50228-334-10) 100 tablet2019-08-270000-00-00NoNoCurrent
50228-334-305022803343030 TABLET in 1 BOTTLE (50228-334-30) 30 tablet2019-08-270000-00-00NoNoCurrent