FDA.reportPublic FDA data

Ethacrynic Acid

Product NDC
60760-773
11-digit product format
607600773
Labeler code
60760
Product ID
60760-773_4c265ce1-7fa6-98f1-e063-6294a90ad0c8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ethacrynic Acid
Dosage form
TABLET
Route
ORAL
Labeler
ST. MARY'S MEDICAL PARK PHARMACY
Application
ANDA211232
Marketing category
ANDA
Marketing start
2023-02-09
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
60760-773-30Ethacrynic Acid30 in 1 BOTTLE, PLASTICTABLET302
60760-773-60Ethacrynic Acid60 in 1 BOTTLE, PLASTICTABLET602

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60760-773-30EA - Each60760-77330d9db28-29b3-47f1-99a2-15ef81ad044012023-04-07
60760-773-60EA - Each60760-773bde6d33c-32b4-44e7-a503-c31edd52e9e612023-04-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60760-773ETHACRYNIC ACID TABLET [ST. MARY'S MEDICAL PARK PHARMACY]1Current NDC, 2 package rows20230219_f4e95ca1-502b-5305-e053-2995a90a5dc7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
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 startSampleExclude flagStatus
60760-773-306076007733030 TABLET in 1 BOTTLE, PLASTIC (60760-773-30) 30 tablet2023-02-09NoNoCurrent
60760-773-606076007736060 TABLET in 1 BOTTLE, PLASTIC (60760-773-60) 60 tablet2023-02-09NoNoCurrent