Home NDC 69238-1126 Ethacrynic Acid
Product NDC 69238-1126
11-digit product format 692381126
Labeler code 69238
Product ID 69238-1126_21b6de3e-2431-4f0c-8440-0ac914ce3d9e
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Ethacrynic Acid
Dosage form TABLET
Route ORAL
Labeler Amneal Pharmaceuticals NY LLC
Application ANDA208805
Marketing category ANDA
Marketing start 2018-05-14
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 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
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 A208805-001 ETHACRYNIC ACID ETHACRYNIC ACID 25MG TABLET / ORAL AB 2018-05-08
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A208805-001 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.
Product history page 1 of 2 · 42 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 2026-08-18 06:07:40 2026-07 A208805-001 ETHACRYNIC ACID 25MG TABLET / ORAL AB 2018-05-08 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A208805-001 ETHACRYNIC ACID 25MG TABLET / ORAL AB 2018-05-08 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208805-001 ETHACRYNIC ACID 25MG TABLET / ORAL AB 2018-05-08 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A208805-001 ETHACRYNIC ACID 25MG TABLET / ORAL AB 2018-05-08 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A208805-001 ETHACRYNIC ACID 25MG TABLET / ORAL AB 2018-05-08 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A208805-001 ETHACRYNIC ACID 25MG TABLET / ORAL AB 2018-05-08 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A208805-001 ETHACRYNIC ACID 25MG TABLET / ORAL AB 2018-05-08 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A208805-001 ETHACRYNIC ACID 25MG TABLET / ORAL AB 2018-05-08 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A208805-001 ETHACRYNIC ACID 25MG TABLET / ORAL AB 2018-05-08 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A208805-001 ETHACRYNIC ACID 25MG TABLET / ORAL AB 2018-05-08 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A208805-001 ETHACRYNIC ACID 25MG TABLET / ORAL AB 2018-05-08 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A208805-001 ETHACRYNIC ACID 25MG TABLET / ORAL AB 2018-05-08 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A208805-001 ETHACRYNIC ACID 25MG TABLET / ORAL AB 2018-05-08 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A208805-001 ETHACRYNIC ACID 25MG TABLET / ORAL AB 2018-05-08 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A208805-001 ETHACRYNIC ACID 25MG TABLET / ORAL AB 2018-05-08 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A208805-001 ETHACRYNIC ACID 25MG TABLET / ORAL AB 2018-05-08 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A208805-001 ETHACRYNIC ACID 25MG TABLET / ORAL AB 2018-05-08 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A208805-001 ETHACRYNIC ACID 25MG TABLET / ORAL AB 2018-05-08 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A208805-001 ETHACRYNIC ACID 25MG TABLET / ORAL AB 2018-05-08 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A208805-001 ETHACRYNIC ACID 25MG TABLET / ORAL AB 2018-05-08 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A208805-001 ETHACRYNIC ACID 25MG TABLET / ORAL AB 2018-05-08 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A208805-001 ETHACRYNIC ACID 25MG TABLET / ORAL AB 2018-05-08 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A208805-001 ETHACRYNIC ACID 25MG TABLET / ORAL AB 2018-05-08 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A208805-001 ETHACRYNIC ACID 25MG TABLET / ORAL AB 2018-05-08 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A208805-001 ETHACRYNIC ACID 25MG TABLET / ORAL AB 2018-05-08 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A208805-001 ETHACRYNIC ACID 25MG TABLET / ORAL AB 2018-05-08 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A208805-001 ETHACRYNIC ACID 25MG TABLET / ORAL AB 2018-05-08 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A208805-001 ETHACRYNIC ACID 25MG TABLET / ORAL AB 2018-05-08 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A208805-001 ETHACRYNIC ACID 25MG TABLET / ORAL AB 2018-05-08 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A208805-001 ETHACRYNIC ACID 25MG TABLET / ORAL AB 2018-05-08 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A208805-001 ETHACRYNIC ACID 25MG TABLET / ORAL AB 2018-05-08 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A208805-001 ETHACRYNIC ACID 25MG TABLET / ORAL AB 2018-05-08 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A208805-001 ETHACRYNIC ACID 25MG TABLET / ORAL AB 2018-05-08 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A208805-001 ETHACRYNIC ACID 25MG TABLET / ORAL AB 2018-05-08 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A208805-001 ETHACRYNIC ACID 25MG TABLET / ORAL AB 2018-05-08 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A208805-001 ETHACRYNIC ACID 25MG TABLET / ORAL AB 2018-05-08 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A208805-001 ETHACRYNIC ACID 25MG TABLET / ORAL AB 2018-05-08 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A208805-001 ETHACRYNIC ACID 25MG TABLET / ORAL AB 2018-05-08 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A208805-001 ETHACRYNIC ACID 25MG TABLET / ORAL AB 2018-05-08 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A208805-001 ETHACRYNIC ACID 25MG TABLET / ORAL AB 2018-05-08 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Ethacrynic Acid
Listing expiration 2027-12-31 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 69238-1126-1 Ethacrynic Acid 100 in 1 BOTTLE TABLET 100 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 69238-1126 ETHACRYNIC ACID TABLET [AMNEAL PHARMACEUTICALS NY LLC] 5 Current NDC, Legacy NDC, 1 package rows 20231231_b9bc3907-bfa7-4d9f-90d9-c2097230f7e4.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 69238-1126-1 69238112601 100 TABLET in 1 BOTTLE (69238-1126-1) 100 tablet 2018-05-14 0000-00-00 No No Current