Ethacrynic Acid

Product NDC
69238-1126
11-digit product format
692381126
Labeler code
69238
Product ID
69238-1126_21b6de3e-2431-4f0c-8440-0ac914ce3d9e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ethacrynic Acid
Dosage form
TABLET
Route
ORAL
Labeler
Amneal Pharmaceuticals NY LLC
Application
ANDA208805
Marketing category
ANDA
Marketing start
2018-05-14
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Ethacrynic Acid
Listing expiration
2027-12-31

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
69238-1126-1Ethacrynic Acid100 in 1 BOTTLETABLET1006

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69238-1126-1EA - Each69238-1126c38bdb99-1c26-465f-ae59-d0560f5f851d12018-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69238-1126ETHACRYNIC ACID TABLET [AMNEAL PHARMACEUTICALS NY LLC]5Current NDC, Legacy NDC, 1 package rows20231231_b9bc3907-bfa7-4d9f-90d9-c2097230f7e4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1251903ethacrynic acid 25 MG Oral TabletPSNb9bc3907-bfa7-4d9f-90d9-c2097230f7e46
1251903ethacrynic acid 25 MG Oral TabletSCDb9bc3907-bfa7-4d9f-90d9-c2097230f7e46

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69238-1126-169238112601100 TABLET in 1 BOTTLE (69238-1126-1) 100 tablet2018-05-140000-00-00NoNoCurrent