Home NDC 69238-1126 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 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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A208805-001 ETHACRYNIC ACID ETHACRYNIC ACID 25MG TABLET / ORAL AB 2018-05-08
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A208805-001 AB
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-01 22:54:32 2026-06 A208805-001 ETHACRYNIC ACID 25MG TABLET / ORAL AB 2018-05-08 a50c72e98297…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-08-01 22:54:32 2026-06 A208805-001 AB 1 a50c72e98297…
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.
Additional Listing Data#
Finished product Yes
Brand name base Ethacrynic Acid
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ETHACRYNIC ACID 25 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination M5DP350VZV Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1251903 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 69238-1126-1 Ethacrynic Acid 100 in 1 BOTTLE TABLET 100 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 69238-1126 ETHACRYNIC ACID TABLET [AMNEAL PHARMACEUTICALS NY LLC] 5 Current NDC, Legacy NDC, 1 package rows 20231231_b9bc3907-bfa7-4d9f-90d9-c2097230f7e4.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 69238-1126-1 69238112601 100 TABLET in 1 BOTTLE (69238-1126-1) 100 tablet 2018-05-14 0000-00-00 No No Current