FDA.reportPublic FDA data

Ethacrynic Acid

Product NDC
0054-0415
11-digit product format
000540415
Labeler code
0054
Product ID
0054-0415_d214319c-d8e9-491f-b7f5-29674983fcc6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ethacrynic Acid
Dosage form
TABLET
Route
ORAL
Labeler
West-Ward Pharmaceuticals Corp.
Application
ANDA207262
Marketing category
ANDA
Marketing start
2017-02-24
Marketing end
0000-00-00
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
2020-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct0054-0415DDiscontinued by firm2026-07-31
excluded packagepackage0054-04150054-0415-25DDiscontinued by firm2026-07-31
excluded packagepackage0054-04150054-0415-29DDiscontinued by firm2026-07-31

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
A207262-001ETHACRYNIC ACIDETHACRYNIC ACID25MGTABLET / ORAL2017-02-23

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 22:54:322026-06A207262-001ETHACRYNIC ACID25MGTABLET / ORAL2017-02-23a50c72e98297…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0054-0415-25EA - Each0054-041590e1d3ff-7ca1-47f2-ab58-23a027cf24d812017-04-05

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0054-0415-2500054041525100 TABLET in 1 BOTTLE (0054-0415-25) 100 tablet2017-02-240000-00-00NoNoCurrent
0054-0415-2900054041529500 TABLET in 1 BOTTLE (0054-0415-29) 500 tablet2017-02-240000-00-00NoNoCurrent