Home NDC 52817-367 Ethacrynic acid
Product NDC 52817-367
11-digit product format 528170367
Labeler code 52817
Product ID 52817-367_fb026274-f2ff-4316-adcf-2590aabf5a76
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Ethacrynic acid
Dosage form TABLET
Route ORAL
Labeler TRUPHARMA LLC
Application ANDA211809
Marketing category ANDA
Marketing start 2019-09-12
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 A211809-001 ETHACRYNIC ACID ETHACRYNIC ACID 25MG TABLET / ORAL AB 2019-07-12
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A211809-001 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 A211809-001 ETHACRYNIC ACID 25MG TABLET / ORAL AB 2019-07-12 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 A211809-001 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 52817-367-10 Ethacrynic acid 100 in 1 BOTTLE TABLET 100 7 52817-367-90 Ethacrynic acid 90 in 1 BOTTLE TABLET 90 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 52817-367 ETHACRYNIC ACID TABLET [TRUPHARMA LLC] 6 Current NDC, Legacy NDC, 2 package rows 20241206_3b2b6ee1-1859-4b02-9ef2-5bbe6427f61a.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 52817-367-10 52817036710 100 TABLET in 1 BOTTLE (52817-367-10) 100 tablet 2019-09-12 0000-00-00 No No Current 52817-367-90 52817036790 90 TABLET in 1 BOTTLE (52817-367-90) 90 tablet 2019-09-12 0000-00-00 No No Current