FDA.reportPublic FDA data

Ethacrynic acid

Product NDC
72134-003
11-digit product format
721340003
Labeler code
72134
Product ID
72134-003_d1cbe78b-a960-4595-84c5-7b8f91109f01
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ethacrynic acid
Dosage form
TABLET
Route
ORAL
Labeler
Agnitio Inc.
Application
ANDA211809
Marketing category
ANDA
Marketing start
2019-05-30
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
2022-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct72134-003IInactivated by FDA2026-07-31
excluded packagepackage72134-00372134-003-01IInactivated by FDA2026-07-31

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
A211809-001ETHACRYNIC ACIDETHACRYNIC ACID25MGTABLET / ORALAB2019-07-12

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A211809-001AB

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 22:54:322026-06A211809-001ETHACRYNIC ACID25MGTABLET / ORALAB2019-07-12a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A211809-001AB1a50c72e98297…

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Ethacrynic acidETHACRYNIC ACIDTRUPHARMA LLC3b2b6ee1-1859-4b02-9ef2-5bbe6427f61a2025-12-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211809
application number: ANDA211809

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
93aead9c-5c26-5d19-73e9-d6c55a939061Product name920210525
01098bd8-4859-4cc2-9426-3489bf88d451Product name420201216

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
72134-003-012023-01-30C16284748780-1f386c64a-09eb-0266-e053-dadaa90a7c1aEthacrynic Acid Tablets USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72134-003-01Ethacrynic acid100 in 1 BOTTLETABLET1003

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72134-003ETHACRYNIC ACID TABLET [AGNITIO INC.]3Legacy NDC, 1 package rows20210129_409c9c72-0693-4d58-bcfe-e71567ed49a0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1251903ethacrynic acid 25 MG Oral TabletPSN409c9c72-0693-4d58-bcfe-e71567ed49a03
1251903ethacrynic acid 25 MG Oral TabletSCD409c9c72-0693-4d58-bcfe-e71567ed49a03

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72134-003-0172134000301100 TABLET in 1 BOTTLE (72134-003-01) 100 tablet2019-05-300000-00-00NoNoCurrent