Home NDC 68682-011 ethacrynic acid
Product NDC 68682-011
11-digit product format 686820011
Labeler code 68682
Product ID 68682-011_4c621e16-3dbb-4774-935e-69270e52fe8e
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name ethacrynic acid
Dosage form TABLET
Route ORAL
Labeler Oceanside Pharmaceuticals
Application NDA016092
Marketing category NDA AUTHORIZED GENERIC
Marketing start 1967-01-10
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 42 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N016092-001 EDECRIN ETHACRYNIC ACID 25MG TABLET / ORAL AB RLD, RS, Approved before 1982 N016092-002 EDECRIN ETHACRYNIC ACID 50MG TABLET / ORAL Approved before 1982
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N016092-001 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 3 · 84 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 N016092-001 EDECRIN 25MG TABLET / ORAL AB RLD, RS, Approved before 1982 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N016092-002 EDECRIN 50MG TABLET / ORAL Approved before 1982 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N016092-001 EDECRIN 25MG TABLET / ORAL AB RLD, RS, Approved before 1982 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N016092-002 EDECRIN 50MG TABLET / ORAL Approved before 1982 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N016092-001 EDECRIN 25MG TABLET / ORAL AB RLD, RS, Approved before 1982 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N016092-002 EDECRIN 50MG TABLET / ORAL Approved before 1982 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N016092-001 EDECRIN 25MG TABLET / ORAL AB RLD, RS, Approved before 1982 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N016092-002 EDECRIN 50MG TABLET / ORAL Approved before 1982 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N016092-001 EDECRIN 25MG TABLET / ORAL AB RLD, RS, Approved before 1982 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N016092-002 EDECRIN 50MG TABLET / ORAL Approved before 1982 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N016092-001 EDECRIN 25MG TABLET / ORAL AB RLD, RS, Approved before 1982 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N016092-002 EDECRIN 50MG TABLET / ORAL Approved before 1982 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N016092-001 EDECRIN 25MG TABLET / ORAL AB RLD, RS, Approved before 1982 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N016092-002 EDECRIN 50MG TABLET / ORAL Approved before 1982 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N016092-001 EDECRIN 25MG TABLET / ORAL AB RLD, RS, Approved before 1982 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N016092-002 EDECRIN 50MG TABLET / ORAL Approved before 1982 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N016092-001 EDECRIN 25MG TABLET / ORAL AB RLD, RS, Approved before 1982 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N016092-002 EDECRIN 50MG TABLET / ORAL Approved before 1982 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N016092-001 EDECRIN 25MG TABLET / ORAL AB RLD, RS, Approved before 1982 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N016092-002 EDECRIN 50MG TABLET / ORAL Approved before 1982 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N016092-001 EDECRIN 25MG TABLET / ORAL AB RLD, RS, Approved before 1982 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N016092-002 EDECRIN 50MG TABLET / ORAL Approved before 1982 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N016092-001 EDECRIN 25MG TABLET / ORAL AB RLD, RS, Approved before 1982 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N016092-002 EDECRIN 50MG TABLET / ORAL Approved before 1982 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N016092-001 EDECRIN 25MG TABLET / ORAL AB RLD, RS, Approved before 1982 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N016092-002 EDECRIN 50MG TABLET / ORAL Approved before 1982 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N016092-001 EDECRIN 25MG TABLET / ORAL AB RLD, RS, Approved before 1982 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N016092-002 EDECRIN 50MG TABLET / ORAL Approved before 1982 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N016092-001 EDECRIN 25MG TABLET / ORAL AB RLD, RS, Approved before 1982 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N016092-002 EDECRIN 50MG TABLET / ORAL Approved before 1982 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N016092-001 EDECRIN 25MG TABLET / ORAL AB RLD, RS, Approved before 1982 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N016092-002 EDECRIN 50MG TABLET / ORAL Approved before 1982 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N016092-001 EDECRIN 25MG TABLET / ORAL AB RLD, RS, Approved before 1982 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N016092-002 EDECRIN 50MG TABLET / ORAL Approved before 1982 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N016092-001 EDECRIN 25MG TABLET / ORAL AB RLD, RS, Approved before 1982 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N016092-002 EDECRIN 50MG TABLET / ORAL Approved before 1982 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N016092-001 EDECRIN 25MG TABLET / ORAL AB RLD, RS, Approved before 1982 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N016092-002 EDECRIN 50MG TABLET / ORAL Approved before 1982 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N016092-001 EDECRIN 25MG TABLET / ORAL AB RLD, RS, Approved before 1982 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N016092-002 EDECRIN 50MG TABLET / ORAL Approved before 1982 bb7c543d1eb4…
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 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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 617325 Internal RxNorm lookup 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 68682-011-10 ethacrynic acid 100 in 1 BOTTLE TABLET 100 14
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68682-011 ETHACRYNIC SODIUM POWDER, FOR SOLUTION ETHACRYNIC ACID TABLET [OCEANSIDE PHARMACEUTICALS] 14 Current NDC, Legacy NDC, 1 package rows 20240802_f127598f-e6b3-4c35-800f-76e4217595ae.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 · 2 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 68682-011-10 68682001110 100 TABLET in 1 BOTTLE (68682-011-10) 100 tablet 1967-01-10 0000-00-00 No No Current