Home NDC 42799-405 Ethacrynic Acid
Product NDC 42799-405
11-digit product format 427990405
Labeler code 42799
Product ID 42799-405_3567b92a-d07e-435b-b7fb-583d29fd0785
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Ethacrynic Acid
Dosage form TABLET
Route ORAL
Labeler Edenbridge Pharmaceuticals LLC.
Application ANDA205609
Marketing category ANDA
Marketing start 2016-07-01
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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A205609-001 ETHACRYNIC ACID ETHACRYNIC ACID 25MG TABLET / ORAL AB 2016-06-30
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A205609-001 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 A205609-001 ETHACRYNIC ACID 25MG TABLET / ORAL AB 2016-06-30 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 A205609-001 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 2026-12-31 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 42799-405-01 Ethacrynic Acid 100 in 1 BOTTLE TABLET 100 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 42799-405 ETHACRYNIC ACID TABLET [EDENBRIDGE PHARMACEUTICALS LLC.] 4 Current NDC, Legacy NDC, 1 package rows 20210729_de7c25a6-ed00-4ef3-883d-f8841f5dbd02.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 42799-405-01 42799040501 100 TABLET in 1 BOTTLE (42799-405-01) 100 tablet 2016-07-01 0000-00-00 No No Current