Home NDC 42023-157-89 ETHACRYNATE SODIUM
Product NDC 42023-157
Requested package NDC 42023-157-89
11-digit product format 420230157
Labeler code 42023
Product ID 42023-157_923d3573-ccd0-4c71-82e3-6167a23b9161
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name ethacrynate sodium
Dosage form INJECTION, POWDER, FOR SOLUTION
Route INTRAVENOUS
Labeler Par Health USA, LLC
Application ANDA205473
Marketing category ANDA
Marketing start 2015-07-30
Substance ETHACRYNATE SODIUM
Active strength 50 mg/50mL
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 Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
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 A205473-001 ETHACRYNATE SODIUM ETHACRYNATE SODIUM EQ 50MG BASE/VIAL INJECTABLE / INJECTION AP 2015-07-29
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A205473-001 AP
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.
Product history page 1 of 2 · 41 observed 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 2026-02-19 14:30 UTC 2026-02 A205473-001 ETHACRYNATE SODIUM EQ 50MG BASE/VIAL INJECTABLE / INJECTION AP 2015-07-29 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A205473-001 ETHACRYNATE SODIUM EQ 50MG BASE/VIAL INJECTABLE / INJECTION AP 2015-07-29 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A205473-001 ETHACRYNATE SODIUM EQ 50MG BASE/VIAL INJECTABLE / INJECTION AP 2015-07-29 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A205473-001 ETHACRYNATE SODIUM EQ 50MG BASE/VIAL INJECTABLE / INJECTION AP 2015-07-29 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A205473-001 ETHACRYNATE SODIUM EQ 50MG BASE/VIAL INJECTABLE / INJECTION AP 2015-07-29 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A205473-001 ETHACRYNATE SODIUM EQ 50MG BASE/VIAL INJECTABLE / INJECTION AP 2015-07-29 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A205473-001 ETHACRYNATE SODIUM EQ 50MG BASE/VIAL INJECTABLE / INJECTION AP 2015-07-29 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A205473-001 ETHACRYNATE SODIUM EQ 50MG BASE/VIAL INJECTABLE / INJECTION AP 2015-07-29 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A205473-001 ETHACRYNATE SODIUM EQ 50MG BASE/VIAL INJECTABLE / INJECTION AP 2015-07-29 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A205473-001 ETHACRYNATE SODIUM EQ 50MG BASE/VIAL INJECTABLE / INJECTION AP 2015-07-29 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A205473-001 ETHACRYNATE SODIUM EQ 50MG BASE/VIAL INJECTABLE / INJECTION AP 2015-07-29 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A205473-001 ETHACRYNATE SODIUM EQ 50MG BASE/VIAL INJECTABLE / INJECTION AP 2015-07-29 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A205473-001 ETHACRYNATE SODIUM EQ 50MG BASE/VIAL INJECTABLE / INJECTION AP 2015-07-29 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A205473-001 ETHACRYNATE SODIUM EQ 50MG BASE/VIAL INJECTABLE / INJECTION AP 2015-07-29 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A205473-001 ETHACRYNATE SODIUM EQ 50MG BASE/VIAL INJECTABLE / INJECTION AP 2015-07-29 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A205473-001 ETHACRYNATE SODIUM EQ 50MG BASE/VIAL INJECTABLE / INJECTION AP 2015-07-29 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A205473-001 ETHACRYNATE SODIUM EQ 50MG BASE/VIAL INJECTABLE / INJECTION AP 2015-07-29 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A205473-001 ETHACRYNATE SODIUM EQ 50MG BASE/VIAL INJECTABLE / INJECTION AP 2015-07-29 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A205473-001 ETHACRYNATE SODIUM EQ 50MG BASE/VIAL INJECTABLE / INJECTION AP 2015-07-29 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A205473-001 ETHACRYNATE SODIUM EQ 50MG BASE/VIAL INJECTABLE / INJECTION AP 2015-07-29 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A205473-001 ETHACRYNATE SODIUM EQ 50MG BASE/VIAL INJECTABLE / INJECTION AP 2015-07-29 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A205473-001 ETHACRYNATE SODIUM EQ 50MG BASE/VIAL INJECTABLE / INJECTION AP 2015-07-29 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A205473-001 ETHACRYNATE SODIUM EQ 50MG BASE/VIAL INJECTABLE / INJECTION AP 2015-07-29 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A205473-001 ETHACRYNATE SODIUM EQ 50MG BASE/VIAL INJECTABLE / INJECTION AP 2015-07-29 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A205473-001 ETHACRYNATE SODIUM EQ 50MG BASE/VIAL INJECTABLE / INJECTION AP 2015-07-29 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A205473-001 ETHACRYNATE SODIUM EQ 50MG BASE/VIAL INJECTABLE / INJECTION AP 2015-07-29 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A205473-001 ETHACRYNATE SODIUM EQ 50MG BASE/VIAL INJECTABLE / INJECTION AP 2015-07-29 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A205473-001 ETHACRYNATE SODIUM EQ 50MG BASE/VIAL INJECTABLE / INJECTION AP 2015-07-29 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A205473-001 ETHACRYNATE SODIUM EQ 50MG BASE/VIAL INJECTABLE / INJECTION AP 2015-07-29 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A205473-001 ETHACRYNATE SODIUM EQ 50MG BASE/VIAL INJECTABLE / INJECTION AP 2015-07-29 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A205473-001 ETHACRYNATE SODIUM EQ 50MG BASE/VIAL INJECTABLE / INJECTION AP 2015-07-29 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A205473-001 ETHACRYNATE SODIUM EQ 50MG BASE/VIAL INJECTABLE / INJECTION AP 2015-07-29 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A205473-001 ETHACRYNATE SODIUM EQ 50MG BASE/VIAL INJECTABLE / INJECTION AP 2015-07-29 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A205473-001 ETHACRYNATE SODIUM EQ 50MG BASE/VIAL INJECTABLE / INJECTION AP 2015-07-29 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A205473-001 ETHACRYNATE SODIUM EQ 50MG BASE/VIAL INJECTABLE / INJECTION AP 2015-07-29 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A205473-001 ETHACRYNATE SODIUM EQ 50MG BASE/VIAL INJECTABLE / INJECTION AP 2015-07-29 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A205473-001 ETHACRYNATE SODIUM EQ 50MG BASE/VIAL INJECTABLE / INJECTION AP 2015-07-29 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A205473-001 ETHACRYNATE SODIUM EQ 50MG BASE/VIAL INJECTABLE / INJECTION AP 2015-07-29 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A205473-001 ETHACRYNATE SODIUM EQ 50MG BASE/VIAL INJECTABLE / INJECTION AP 2015-07-29 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A205473-001 ETHACRYNATE SODIUM EQ 50MG BASE/VIAL INJECTABLE / INJECTION AP 2015-07-29 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
Additional Listing Data#
Finished product Yes
Brand name base ETHACRYNATE SODIUM
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ETHACRYNATE SODIUM 50 mg/50mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination K41MYV7MPM Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 617325 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 42023-157-01 ETHACRYNATE SODIUM 50 mL in 1 VIAL INJECTION, POWDER, FOR SOLUTION 50 6 42023-157-01 ETHACRYNATE SODIUM 1 in 1 CARTON INJECTION, POWDER, FOR SOLUTION 1 6
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded ethacrynate sodium ACTIVE INGREDIENT K41MYV7MPM ETHACRYNATE SODIUM INJECTION, POWDER, FOR SOLUTION [PAR PHARMACEUTICAL, INC.] 1 ethacrynic acid ACTIVE MOIETY M5DP350VZV ETHACRYNATE SODIUM INJECTION, POWDER, FOR SOLUTION [PAR PHARMACEUTICAL, INC.] 1 mannitol INACTIVE INGREDIENT 3OWL53L36A ETHACRYNATE SODIUM INJECTION, POWDER, FOR SOLUTION [PAR PHARMACEUTICAL, INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 42023-157 ETHACRYNATE SODIUM INJECTION, POWDER, FOR SOLUTION [ENDO USA, INC.] 5 Current NDC, Legacy NDC, 2 package rows 20241114_3313ed5d-7991-408f-872b-d5a701aa6d83.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
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 42023-157-89 42023015789 1 VIAL in 1 CARTON (42023-157-89) > 50 mL in 1 VIAL 1 vial 2016-05-19 0000-00-00 No No Current