FDA.reportPublic FDA data

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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A211232-001ETHACRYNIC ACIDETHACRYNIC ACID25MGTABLET / ORALAB2019-08-27

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A211232-001AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A211232-001ETHACRYNIC ACID25MGTABLET / ORALAB2019-08-27a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A211232-001AB1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Ethacrynic AcidETHACRYNIC ACIDSt. Mary's Medical Park Pharmacyf4e95ca1-502b-5305-e053-2995a90a5dc72026-06-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211232
application number: ANDA211232
Ethacrynic AcidETHACRYNIC ACIDBryant Ranch Prepackfd1b7fb4-fe56-4f2d-860d-bbcea16adfea2025-02-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211232
application number: ANDA211232
Ethacrynic AcidETHACRYNIC ACIDScieGen Pharmaceuticals Incd400d264-c231-4bdf-8180-eb11ab4e9f292024-12-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211232
application number: ANDA211232
ndc (product): 50228-334

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 UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
M5DP350VZVInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1251903Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
d400d264-c231-4bdf-8180-eb11ab4e9f29Available on FDA.report

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