SODIUM EDECRIN

Product NDC
25010-210
11-digit product format
250100210
Labeler code
25010
Product ID
25010-210_fc9fc557-cd95-4c2a-869e-68c0619fd35e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ethacrynate sodium
Dosage form
POWDER, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Bausch Health US, LLC
Application
NDA016093
Marketing category
NDA
Marketing start
1967-01-10
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
2021-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct25010-210DDiscontinued by firm2026-08-10
excluded packagepackage25010-21025010-210-27DDiscontinued by firm2026-08-10

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 · 22 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage25010-210-27d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage25010-210-27f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage25010-210-272ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage25010-210-27a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage25010-210-27cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage25010-210-27cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage25010-210-27302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage25010-210-27ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage25010-210-270efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage25010-210-27ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage25010-210-27367a005e9d99…383a685ebd0f…

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N016093-001EDECRINETHACRYNATE SODIUMEQ 50MG BASE/VIALINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
N016093-001AP

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N016093-001EDECRINEQ 50MG BASE/VIALINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N016093-001EDECRINEQ 50MG BASE/VIALINJECTABLE / INJECTIONAPRLD, RS, Approved before 198231067a03dcf5…
2025-08-23 18:47 UTC2025-08N016093-001EDECRINEQ 50MG BASE/VIALINJECTABLE / INJECTIONAPRLD, RS, Approved before 19826a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N016093-001EDECRINEQ 50MG BASE/VIALINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N016093-001EDECRINEQ 50MG BASE/VIALINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N016093-001EDECRINEQ 50MG BASE/VIALINJECTABLE / INJECTIONAPRLD, RS, Approved before 198203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N016093-001EDECRINEQ 50MG BASE/VIALINJECTABLE / INJECTIONAPRLD, RS, Approved before 19822680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N016093-001EDECRINEQ 50MG BASE/VIALINJECTABLE / INJECTIONAPRLD, RS, Approved before 19825bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N016093-001EDECRINEQ 50MG BASE/VIALINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N016093-001EDECRINEQ 50MG BASE/VIALINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N016093-001EDECRINEQ 50MG BASE/VIALINJECTABLE / INJECTIONAPRLD, RS, Approved before 198279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N016093-001EDECRINEQ 50MG BASE/VIALINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N016093-001EDECRINEQ 50MG BASE/VIALINJECTABLE / INJECTIONAPRLD, RS, Approved before 19821e350fbaab3a…
2024-05-31 18:47 UTC2024-05N016093-001EDECRINEQ 50MG BASE/VIALINJECTABLE / INJECTIONAPRLD, RS, Approved before 19828072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N016093-001EDECRINEQ 50MG BASE/VIALINJECTABLE / INJECTIONAPRLD, RS, Approved before 19825c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N016093-001EDECRINEQ 50MG BASE/VIALINJECTABLE / INJECTIONAPRLD, RS, Approved before 19825d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N016093-001EDECRINEQ 50MG BASE/VIALINJECTABLE / INJECTIONAPRLD, RS, Approved before 19824b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N016093-001EDECRINEQ 50MG BASE/VIALINJECTABLE / INJECTIONAPRLD, RS, Approved before 198274a2ff9319b5…
2022-03-09 01:35 UTC2022-03N016093-001EDECRINEQ 50MG BASE/VIALINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N016093-001EDECRINEQ 50MG BASE/VIALINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N016093-001EDECRINEQ 50MG BASE/VIALINJECTABLE / INJECTIONAPRLD, RS, Approved before 198287673890dc5c…
2021-03-12 10:30 UTC2021-03N016093-001EDECRINEQ 50MG BASE/VIALINJECTABLE / INJECTIONAPRLD, RS, Approved before 19825aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N016093-001EDECRINEQ 50MG BASE/VIALINJECTABLE / INJECTIONAPRLD, RS, Approved before 19828869cabd3fbd…
2020-11-12 02:37 UTC2020-11N016093-001EDECRINEQ 50MG BASE/VIALINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982c0c555d07b60…
2019-12-14 00:12 UTC2019-12N016093-001EDECRINEQ 50MG BASE/VIALINJECTABLE / INJECTIONAPRLD, RS, Approved before 19823f01610625f2…
2019-09-15 20:21 UTC2019-09N016093-001EDECRINEQ 50MG BASE/VIALINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982b00525d2431f…
2019-07-19 19:46 UTC2019-07N016093-001EDECRINEQ 50MG BASE/VIALINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N016093-001EDECRINEQ 50MG BASE/VIALINJECTABLE / INJECTIONAPRLD, RS, Approved before 19826a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N016093-001EDECRINEQ 50MG BASE/VIALINJECTABLE / INJECTIONAPRLD, RS, Approved before 19821c564ffb4f44…
2023-12-20 04:57 UTC2023-12N016093-001EDECRINEQ 50MG BASE/VIALINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N016093-001EDECRINEQ 50MG BASE/VIALINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N016093-001EDECRINEQ 50MG BASE/VIALINJECTABLE / INJECTIONAPRLD, RS, Approved before 19829b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N016093-001EDECRINEQ 50MG BASE/VIALINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N016093-001EDECRINEQ 50MG BASE/VIALINJECTABLE / INJECTIONAPRLD, RS, Approved before 19823f0d92c62455…
2023-05-13 08:27 UTC2023-05N016093-001EDECRINEQ 50MG BASE/VIALINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982053a50430f4f…
2023-01-26 05:58 UTC2023-01N016093-001EDECRINEQ 50MG BASE/VIALINJECTABLE / INJECTIONAPRLD, RS, Approved before 19823bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N016093-001EDECRINEQ 50MG BASE/VIALINJECTABLE / INJECTIONAPRLD, RS, Approved before 19823a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N016093-001EDECRINEQ 50MG BASE/VIALINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N016093-001EDECRINEQ 50MG BASE/VIALINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N016093-001EDECRINEQ 50MG BASE/VIALINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982cb3db0bc1861…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02N016093-001AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N016093-001AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08N016093-001AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N016093-001AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N016093-001AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N016093-001AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N016093-001AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N016093-001AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N016093-001AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N016093-001AP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N016093-001AP179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N016093-001AP1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N016093-001AP11e350fbaab3a…
2024-05-31 18:47 UTC2024-05N016093-001AP18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N016093-001AP15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N016093-001AP15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N016093-001AP14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N016093-001AP174a2ff9319b5…
2022-03-09 01:35 UTC2022-03N016093-001AP1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N016093-001AP1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N016093-001AP187673890dc5c…
2021-03-12 10:30 UTC2021-03N016093-001AP15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N016093-001AP18869cabd3fbd…
2020-11-12 02:37 UTC2020-11N016093-001AP1c0c555d07b60…
2019-12-14 00:12 UTC2019-12N016093-001AP13f01610625f2…
2019-09-15 20:21 UTC2019-09N016093-001AP1b00525d2431f…
2019-07-19 19:46 UTC2019-07N016093-001AP1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N016093-001AP16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N016093-001AP11c564ffb4f44…
2023-12-20 04:57 UTC2023-12N016093-001AP1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N016093-001AP1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N016093-001AP19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N016093-001AP1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N016093-001AP13f0d92c62455…
2023-05-13 08:27 UTC2023-05N016093-001AP1053a50430f4f…
2023-01-26 05:58 UTC2023-01N016093-001AP13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N016093-001AP13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N016093-001AP1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N016093-001AP1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N016093-001AP1cb3db0bc1861…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
93aead9c-5c26-5d19-73e9-d6c55a939061Product name920210525
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
01098bd8-4859-4cc2-9426-3489bf88d451Product name420201216
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
25010-210-27SODIUM EDECRIN50 mL in 1 VIALPOWDER, FOR SOLUTION5010
25010-210-27SODIUM EDECRIN1 in 1 CARTONPOWDER, FOR SOLUTION110

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
25010-210-27EA - Each25010-210f6cdc2a7-f838-4c08-b097-0bd4aa96407312013-02-13

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
25010-210EDECRIN (ETHACRYNIC ACID) TABLET SODIUM EDECRIN (ETHACRYNATE SODIUM) POWDER, FOR SOLUTION [BAUSCH HEALTH US, LLC]10Legacy NDC, 2 package rows20240806_1efe378e-fee1-4ae9-8ea5-0fe2265fe2d8.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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
EDECRINETHACRYNIC ACIDBausch Health US, LLC1efe378e-fee1-4ae9-8ea5-0fe2265fe2d82020-08-31Warnings, Adverse reactionsExact identifier
ndc (product): 25010-210

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1251905Edecrin 25 MG Oral TabletPSN1efe378e-fee1-4ae9-8ea5-0fe2265fe2d810
211509Edecrin Sodium 50 MG InjectionPSN1efe378e-fee1-4ae9-8ea5-0fe2265fe2d810
617325ethacrynate sodium 50 MG InjectionPSN1efe378e-fee1-4ae9-8ea5-0fe2265fe2d810
1251903ethacrynic acid 25 MG Oral TabletPSN1efe378e-fee1-4ae9-8ea5-0fe2265fe2d810
211509ethacrynate sodium 50 MG Injection [Edecrin]SBD1efe378e-fee1-4ae9-8ea5-0fe2265fe2d810
1251905ethacrynic acid 25 MG Oral Tablet [Edecrin]SBD1efe378e-fee1-4ae9-8ea5-0fe2265fe2d810
617325ethacrynate sodium 50 MG InjectionSCD1efe378e-fee1-4ae9-8ea5-0fe2265fe2d810
1251903ethacrynic acid 25 MG Oral TabletSCD1efe378e-fee1-4ae9-8ea5-0fe2265fe2d810
1251905Edecrin 25 MG Oral TabletSY1efe378e-fee1-4ae9-8ea5-0fe2265fe2d810
211509Edecrin 50 MG InjectionSY1efe378e-fee1-4ae9-8ea5-0fe2265fe2d810
211509Edecrin Sodium 50 MG (equivalent to ethacrynic acid 50 MG) InjectionSY1efe378e-fee1-4ae9-8ea5-0fe2265fe2d810
617325ethacrynate sodium 50 MG (equivalent to ethacrynic acid 50 MG) InjectionSY1efe378e-fee1-4ae9-8ea5-0fe2265fe2d810

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
25010-210-27250100210271 VIAL in 1 CARTON (25010-210-27) > 50 mL in 1 VIAL1 vial1967-01-100000-00-00NoNoCurrent