Home NDC 69315-701 ETHACRYNATE SODIUM
Product NDC 69315-701
11-digit product format 693150701
Labeler code 69315
Product ID 69315-701_f2c45a04-b3df-48cd-93e2-edb917a029cf
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name ETHACRYNATE SODIUM
Dosage form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route INTRAVENOUS
Labeler Leading Pharma, LLC
Application ANDA208663
Marketing category ANDA
Marketing start 2026-01-09
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 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 A208663-001 ETHACRYNATE SODIUM ETHACRYNATE SODIUM EQ 50MG BASE/VIAL INJECTABLE / INJECTION AP 2020-06-09
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A208663-001 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.
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 A208663-001 ETHACRYNATE SODIUM EQ 50MG BASE/VIAL INJECTABLE / INJECTION AP 2020-06-09 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208663-001 ETHACRYNATE SODIUM EQ 50MG BASE/VIAL INJECTABLE / INJECTION AP 2020-06-09 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A208663-001 ETHACRYNATE SODIUM EQ 50MG BASE/VIAL INJECTABLE / INJECTION AP 2020-06-09 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A208663-001 ETHACRYNATE SODIUM EQ 50MG BASE/VIAL INJECTABLE / INJECTION AP 2020-06-09 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A208663-001 ETHACRYNATE SODIUM EQ 50MG BASE/VIAL INJECTABLE / INJECTION AP 2020-06-09 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A208663-001 ETHACRYNATE SODIUM EQ 50MG BASE/VIAL INJECTABLE / INJECTION AP 2020-06-09 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A208663-001 ETHACRYNATE SODIUM EQ 50MG BASE/VIAL INJECTABLE / INJECTION AP 2020-06-09 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A208663-001 ETHACRYNATE SODIUM EQ 50MG BASE/VIAL INJECTABLE / INJECTION AP 2020-06-09 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A208663-001 ETHACRYNATE SODIUM EQ 50MG BASE/VIAL INJECTABLE / INJECTION AP 2020-06-09 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A208663-001 ETHACRYNATE SODIUM EQ 50MG BASE/VIAL INJECTABLE / INJECTION AP 2020-06-09 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A208663-001 ETHACRYNATE SODIUM EQ 50MG BASE/VIAL INJECTABLE / INJECTION AP 2020-06-09 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A208663-001 ETHACRYNATE SODIUM EQ 50MG BASE/VIAL INJECTABLE / INJECTION AP 2020-06-09 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A208663-001 ETHACRYNATE SODIUM EQ 50MG BASE/VIAL INJECTABLE / INJECTION AP 2020-06-09 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A208663-001 ETHACRYNATE SODIUM EQ 50MG BASE/VIAL INJECTABLE / INJECTION AP 2020-06-09 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A208663-001 ETHACRYNATE SODIUM EQ 50MG BASE/VIAL INJECTABLE / INJECTION AP 2020-06-09 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A208663-001 ETHACRYNATE SODIUM EQ 50MG BASE/VIAL INJECTABLE / INJECTION AP 2020-06-09 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A208663-001 ETHACRYNATE SODIUM EQ 50MG BASE/VIAL INJECTABLE / INJECTION AP 2020-06-09 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A208663-001 ETHACRYNATE SODIUM EQ 50MG BASE/VIAL INJECTABLE / INJECTION AP 2020-06-09 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A208663-001 ETHACRYNATE SODIUM EQ 50MG BASE/VIAL INJECTABLE / INJECTION AP 2020-06-09 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A208663-001 ETHACRYNATE SODIUM EQ 50MG BASE/VIAL INJECTABLE / INJECTION AP 2020-06-09 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A208663-001 ETHACRYNATE SODIUM EQ 50MG BASE/VIAL INJECTABLE / INJECTION AP 2020-06-09 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A208663-001 ETHACRYNATE SODIUM EQ 50MG BASE/VIAL INJECTABLE / INJECTION AP 2020-06-09 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A208663-001 ETHACRYNATE SODIUM EQ 50MG BASE/VIAL INJECTABLE / INJECTION AP 2020-06-09 c0c555d07b60…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A208663-001 ETHACRYNATE SODIUM EQ 50MG BASE/VIAL INJECTABLE / INJECTION AP 2020-06-09 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A208663-001 ETHACRYNATE SODIUM EQ 50MG BASE/VIAL INJECTABLE / INJECTION AP 2020-06-09 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A208663-001 ETHACRYNATE SODIUM EQ 50MG BASE/VIAL INJECTABLE / INJECTION AP 2020-06-09 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A208663-001 ETHACRYNATE SODIUM EQ 50MG BASE/VIAL INJECTABLE / INJECTION AP 2020-06-09 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A208663-001 ETHACRYNATE SODIUM EQ 50MG BASE/VIAL INJECTABLE / INJECTION AP 2020-06-09 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A208663-001 ETHACRYNATE SODIUM EQ 50MG BASE/VIAL INJECTABLE / INJECTION AP 2020-06-09 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A208663-001 ETHACRYNATE SODIUM EQ 50MG BASE/VIAL INJECTABLE / INJECTION AP 2020-06-09 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A208663-001 ETHACRYNATE SODIUM EQ 50MG BASE/VIAL INJECTABLE / INJECTION AP 2020-06-09 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A208663-001 ETHACRYNATE SODIUM EQ 50MG BASE/VIAL INJECTABLE / INJECTION AP 2020-06-09 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A208663-001 ETHACRYNATE SODIUM EQ 50MG BASE/VIAL INJECTABLE / INJECTION AP 2020-06-09 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A208663-001 ETHACRYNATE SODIUM EQ 50MG BASE/VIAL INJECTABLE / INJECTION AP 2020-06-09 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A208663-001 ETHACRYNATE SODIUM EQ 50MG BASE/VIAL INJECTABLE / INJECTION AP 2020-06-09 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A208663-001 ETHACRYNATE SODIUM EQ 50MG BASE/VIAL INJECTABLE / INJECTION AP 2020-06-09 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A208663-001 ETHACRYNATE SODIUM EQ 50MG BASE/VIAL INJECTABLE / INJECTION AP 2020-06-09 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base ETHACRYNATE SODIUM
Listing expiration 2027-12-31 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 69315-701-50 ETHACRYNATE SODIUM 1 in 1 CARTON INJECTION, POWDER, LYOPHILIZED, 1 3 69315-701-50 ETHACRYNATE SODIUM 50 mL in 1 VIAL, SINGLE-DOSE INJECTION, POWDER, LYOPHILIZED, 50 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 69315-701 ETHACRYNATE SODIUM INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [LEADING PHARMA, LLC] 2 Current NDC, Legacy NDC, 2 package rows 20201015_e24e7440-a958-6fd0-6bfe-1bd29e638657.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 Marketing start Marketing end Sample Exclude flag Status 69315-701-50 69315070150 1 VIAL, SINGLE-DOSE in 1 CARTON (69315-701-50) / 50 mL in 1 VIAL, SINGLE-DOSE 2026-01-09 0000-00-00 No No Current