Ethacrynic Acid

Product NDC
42799-405
11-digit product format
427990405
Labeler code
42799
Product ID
42799-405_3567b92a-d07e-435b-b7fb-583d29fd0785
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ethacrynic Acid
Dosage form
TABLET
Route
ORAL
Labeler
Edenbridge Pharmaceuticals LLC.
Application
ANDA205609
Marketing category
ANDA
Marketing start
2016-07-01
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
42799-405-01Ethacrynic Acid100 in 1 BOTTLETABLET1005

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42799-405ETHACRYNIC ACID TABLET [EDENBRIDGE PHARMACEUTICALS LLC.]4Current NDC, Legacy NDC, 1 package rows20210729_de7c25a6-ed00-4ef3-883d-f8841f5dbd02.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1251903ethacrynic acid 25 MG Oral TabletPSNde7c25a6-ed00-4ef3-883d-f8841f5dbd025
1251903ethacrynic acid 25 MG Oral TabletSCDde7c25a6-ed00-4ef3-883d-f8841f5dbd025

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
42799-405-0142799040501100 TABLET in 1 BOTTLE (42799-405-01) 100 tablet2016-07-010000-00-00NoNoCurrent