Home NDC 68382-246 Ethacrynate Sodium
Product NDC 68382-246
11-digit product format 683820246
Labeler code 68382
Product ID 68382-246_8d05996d-e08d-415c-921c-0ad9b70dfbdd
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Ethacrynate Sodium
Dosage form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route INTRAVENOUS
Labeler Zydus Pharmaceuticals USA Inc.
Application ANDA207758
Marketing category ANDA
Marketing start 2018-01-24
Marketing end 0000-00-00
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 2023-12-31
Current FDA listing Historical FDA.report record 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 · 4 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 68382-246-01 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 68382-246-01 f5e01cc5f278…a2eaf40c39c3…
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 A207758-001 ETHACRYNATE SODIUM ETHACRYNATE SODIUM EQ 50MG BASE/VIAL INJECTABLE / INJECTION AP 2017-11-17
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A207758-001 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 A207758-001 ETHACRYNATE SODIUM EQ 50MG BASE/VIAL INJECTABLE / INJECTION AP 2017-11-17 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A207758-001 ETHACRYNATE SODIUM EQ 50MG BASE/VIAL INJECTABLE / INJECTION AP 2017-11-17 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A207758-001 ETHACRYNATE SODIUM EQ 50MG BASE/VIAL INJECTABLE / INJECTION AP 2017-11-17 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A207758-001 ETHACRYNATE SODIUM EQ 50MG BASE/VIAL INJECTABLE / INJECTION AP 2017-11-17 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A207758-001 ETHACRYNATE SODIUM EQ 50MG BASE/VIAL INJECTABLE / INJECTION AP 2017-11-17 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A207758-001 ETHACRYNATE SODIUM EQ 50MG BASE/VIAL INJECTABLE / INJECTION AP 2017-11-17 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A207758-001 ETHACRYNATE SODIUM EQ 50MG BASE/VIAL INJECTABLE / INJECTION AP 2017-11-17 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A207758-001 ETHACRYNATE SODIUM EQ 50MG BASE/VIAL INJECTABLE / INJECTION AP 2017-11-17 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A207758-001 ETHACRYNATE SODIUM EQ 50MG BASE/VIAL INJECTABLE / INJECTION AP 2017-11-17 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A207758-001 ETHACRYNATE SODIUM EQ 50MG BASE/VIAL INJECTABLE / INJECTION AP 2017-11-17 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A207758-001 ETHACRYNATE SODIUM EQ 50MG BASE/VIAL INJECTABLE / INJECTION AP 2017-11-17 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A207758-001 ETHACRYNATE SODIUM EQ 50MG BASE/VIAL INJECTABLE / INJECTION AP 2017-11-17 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A207758-001 ETHACRYNATE SODIUM EQ 50MG BASE/VIAL INJECTABLE / INJECTION AP 2017-11-17 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A207758-001 ETHACRYNATE SODIUM EQ 50MG BASE/VIAL INJECTABLE / INJECTION AP 2017-11-17 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A207758-001 ETHACRYNATE SODIUM EQ 50MG BASE/VIAL INJECTABLE / INJECTION AP 2017-11-17 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A207758-001 ETHACRYNATE SODIUM EQ 50MG BASE/VIAL INJECTABLE / INJECTION AP 2017-11-17 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A207758-001 ETHACRYNATE SODIUM EQ 50MG BASE/VIAL INJECTABLE / INJECTION AP 2017-11-17 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A207758-001 ETHACRYNATE SODIUM EQ 50MG BASE/VIAL INJECTABLE / INJECTION AP 2017-11-17 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A207758-001 ETHACRYNATE SODIUM EQ 50MG BASE/VIAL INJECTABLE / INJECTION AP 2017-11-17 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A207758-001 ETHACRYNATE SODIUM EQ 50MG BASE/VIAL INJECTABLE / INJECTION AP 2017-11-17 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A207758-001 ETHACRYNATE SODIUM EQ 50MG BASE/VIAL INJECTABLE / INJECTION AP 2017-11-17 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A207758-001 ETHACRYNATE SODIUM EQ 50MG BASE/VIAL INJECTABLE / INJECTION AP 2017-11-17 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A207758-001 ETHACRYNATE SODIUM EQ 50MG BASE/VIAL INJECTABLE / INJECTION AP 2017-11-17 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A207758-001 ETHACRYNATE SODIUM EQ 50MG BASE/VIAL INJECTABLE / INJECTION AP 2017-11-17 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A207758-001 ETHACRYNATE SODIUM EQ 50MG BASE/VIAL INJECTABLE / INJECTION AP 2017-11-17 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A207758-001 ETHACRYNATE SODIUM EQ 50MG BASE/VIAL INJECTABLE / INJECTION AP 2017-11-17 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A207758-001 ETHACRYNATE SODIUM EQ 50MG BASE/VIAL INJECTABLE / INJECTION AP 2017-11-17 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A207758-001 ETHACRYNATE SODIUM EQ 50MG BASE/VIAL INJECTABLE / INJECTION AP 2017-11-17 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A207758-001 ETHACRYNATE SODIUM EQ 50MG BASE/VIAL INJECTABLE / INJECTION AP 2017-11-17 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A207758-001 ETHACRYNATE SODIUM EQ 50MG BASE/VIAL INJECTABLE / INJECTION AP 2017-11-17 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A207758-001 ETHACRYNATE SODIUM EQ 50MG BASE/VIAL INJECTABLE / INJECTION AP 2017-11-17 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A207758-001 ETHACRYNATE SODIUM EQ 50MG BASE/VIAL INJECTABLE / INJECTION AP 2017-11-17 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A207758-001 ETHACRYNATE SODIUM EQ 50MG BASE/VIAL INJECTABLE / INJECTION AP 2017-11-17 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A207758-001 ETHACRYNATE SODIUM EQ 50MG BASE/VIAL INJECTABLE / INJECTION AP 2017-11-17 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A207758-001 ETHACRYNATE SODIUM EQ 50MG BASE/VIAL INJECTABLE / INJECTION AP 2017-11-17 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A207758-001 ETHACRYNATE SODIUM EQ 50MG BASE/VIAL INJECTABLE / INJECTION AP 2017-11-17 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A207758-001 ETHACRYNATE SODIUM EQ 50MG BASE/VIAL INJECTABLE / INJECTION AP 2017-11-17 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A207758-001 ETHACRYNATE SODIUM EQ 50MG BASE/VIAL INJECTABLE / INJECTION AP 2017-11-17 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A207758-001 ETHACRYNATE SODIUM EQ 50MG BASE/VIAL INJECTABLE / INJECTION AP 2017-11-17 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A207758-001 ETHACRYNATE SODIUM EQ 50MG BASE/VIAL INJECTABLE / INJECTION AP 2017-11-17 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68382-246 ETHACRYNATE SODIUM INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [ZYDUS PHARMACEUTICALS USA INC.] 2 Legacy NDC 20221118_db836794-dc0f-4109-9c27-6aaf391b3389.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 68382-246-01 68382024601 1 VIAL in 1 CARTON (68382-246-01) > 50 mL in 1 VIAL 1 vial 2018-01-24 0000-00-00 No No Current