EDECRIN

Product NDC
25010-215
11-digit product format
250100215
Labeler code
25010
Product ID
25010-215_4c442b87-1bbd-40e6-8c40-004f5f46e996
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ethacrynic acid
Dosage form
TABLET
Route
ORAL
Labeler
Bausch Health US, LLC
Application
NDA016092
Marketing category
NDA
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

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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage25010-21525010-215-65DDiscontinued by firm2026-08-17

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 · 12 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N016092-001EDECRINETHACRYNIC ACID25MGTABLET / ORALABRLD, RS, Approved before 1982
N016092-002EDECRINETHACRYNIC ACID50MGTABLET / ORALApproved before 1982

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
N016092-001AB

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07N016092-001EDECRIN25MGTABLET / ORALABRLD, RS, Approved before 1982caaa826d4ba7…
2026-08-18 06:07:402026-07N016092-002EDECRIN50MGTABLET / ORALApproved before 1982caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N016092-001EDECRIN25MGTABLET / ORALABRLD, RS, Approved before 1982011fe1cb6892…
2026-02-19 14:30 UTC2026-02N016092-002EDECRIN50MGTABLET / ORALApproved before 1982011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N016092-001EDECRIN25MGTABLET / ORALABRLD, RS, Approved before 198231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N016092-002EDECRIN50MGTABLET / ORALApproved before 198231067a03dcf5…
2025-08-23 18:47 UTC2025-08N016092-001EDECRIN25MGTABLET / ORALABRLD, RS, Approved before 19826a471c1ec25d…
2025-08-23 18:47 UTC2025-08N016092-002EDECRIN50MGTABLET / ORALApproved before 19826a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N016092-001EDECRIN25MGTABLET / ORALABRLD, RS, Approved before 1982fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N016092-002EDECRIN50MGTABLET / ORALApproved before 1982fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N016092-001EDECRIN25MGTABLET / ORALABRLD, RS, Approved before 1982b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N016092-002EDECRIN50MGTABLET / ORALApproved before 1982b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N016092-001EDECRIN25MGTABLET / ORALABRLD, RS, Approved before 198203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N016092-002EDECRIN50MGTABLET / ORALApproved before 198203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N016092-001EDECRIN25MGTABLET / ORALABRLD, RS, Approved before 19822680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N016092-002EDECRIN50MGTABLET / ORALApproved before 19822680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N016092-001EDECRIN25MGTABLET / ORALABRLD, RS, Approved before 19825bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N016092-002EDECRIN50MGTABLET / ORALApproved before 19825bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N016092-001EDECRIN25MGTABLET / ORALABRLD, RS, Approved before 1982d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N016092-002EDECRIN50MGTABLET / ORALApproved before 1982d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N016092-001EDECRIN25MGTABLET / ORALABRLD, RS, Approved before 1982d06236e962d9…
2024-10-29 15:01 UTC2024-10N016092-002EDECRIN50MGTABLET / ORALApproved before 1982d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N016092-001EDECRIN25MGTABLET / ORALABRLD, RS, Approved before 198279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N016092-002EDECRIN50MGTABLET / ORALApproved before 198279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N016092-001EDECRIN25MGTABLET / ORALABRLD, RS, Approved before 1982301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N016092-002EDECRIN50MGTABLET / ORALApproved before 1982301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N016092-001EDECRIN25MGTABLET / ORALABRLD, RS, Approved before 19821e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N016092-002EDECRIN50MGTABLET / ORALApproved before 19821e350fbaab3a…
2024-05-31 18:47 UTC2024-05N016092-001EDECRIN25MGTABLET / ORALABRLD, RS, Approved before 19828072bd15b7f6…
2024-05-31 18:47 UTC2024-05N016092-002EDECRIN50MGTABLET / ORALApproved before 19828072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N016092-001EDECRIN25MGTABLET / ORALABRLD, RS, Approved before 19825c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N016092-002EDECRIN50MGTABLET / ORALApproved before 19825c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N016092-001EDECRIN25MGTABLET / ORALABRLD, RS, Approved before 19825d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N016092-002EDECRIN50MGTABLET / ORALApproved before 19825d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N016092-001EDECRIN25MGTABLET / ORALABRLD, RS, Approved before 19824b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N016092-002EDECRIN50MGTABLET / ORALApproved before 19824b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N016092-001EDECRIN25MGTABLET / ORALABRLD, RS, Approved before 198274a2ff9319b5…
2019-12-13 00:20 UTC2019-12N016092-002EDECRIN50MGTABLET / ORALApproved before 198274a2ff9319b5…
2022-03-09 01:35 UTC2022-03N016092-001EDECRIN25MGTABLET / ORALABRLD, RS, Approved before 1982bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N016092-002EDECRIN50MGTABLET / ORALApproved before 1982bb7c543d1eb4…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07N016092-001AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N016092-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N016092-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08N016092-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N016092-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N016092-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N016092-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N016092-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N016092-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N016092-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N016092-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N016092-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N016092-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N016092-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05N016092-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N016092-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N016092-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N016092-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N016092-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03N016092-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N016092-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N016092-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03N016092-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N016092-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11N016092-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12N016092-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09N016092-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07N016092-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N016092-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N016092-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12N016092-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N016092-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N016092-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N016092-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N016092-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05N016092-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01N016092-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N016092-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N016092-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N016092-001AB1e64feba35796…

Additional Listing Data#

Finished product
Yes
Brand name base
EDECRIN
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ETHACRYNIC ACID25 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
M5DP350VZVInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
211509Internal RxNorm lookup
617325Internal RxNorm lookup
1251903Internal RxNorm lookup
1251905Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1efe378e-fee1-4ae9-8ea5-0fe2265fe2d8Available on FDA.report

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
25010-215-15EDECRIN100 in 1 BOTTLETABLET10010
25010-215-65EDECRIN6 in 1 BOTTLETABLET610

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
25010-215-15EA - Each25010-215c24068b7-f24e-4f36-b827-91737605cffa12013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ethacrynic acidACTIVE INGREDIENTM5DP350VZVEDECRIN (ETHACRYNIC ACID) TABLET [ATON PHARMA, INC.]2
ethacrynic acidACTIVE MOIETYM5DP350VZVEDECRIN (ETHACRYNIC ACID) TABLET [ATON PHARMA, INC.]2
LactoseINACTIVE INGREDIENTJ2B2A4N98GEDECRIN (ETHACRYNIC ACID) TABLET [ATON PHARMA, INC.]2
Magnesium StearateINACTIVE INGREDIENT70097M6I30EDECRIN (ETHACRYNIC ACID) TABLET [ATON PHARMA, INC.]2
Silicon DioxideINACTIVE INGREDIENTETJ7Z6XBU4EDECRIN (ETHACRYNIC ACID) TABLET [ATON PHARMA, INC.]2
TalcINACTIVE INGREDIENT7SEV7J4R1UEDECRIN (ETHACRYNIC ACID) TABLET [ATON PHARMA, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
25010-215EDECRIN (ETHACRYNIC ACID) TABLET SODIUM EDECRIN (ETHACRYNATE SODIUM) POWDER, FOR SOLUTION [BAUSCH HEALTH US, LLC]10Current NDC, Legacy 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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ethacrynic acidETHACRYNIC ACIDOceanside Pharmaceuticalsf127598f-e6b3-4c35-800f-76e4217595ae2023-08-31Warnings, Adverse reactionsExact identifier
application applno (NDA): 016092
application number: NDA016092
EDECRINETHACRYNIC ACIDBausch Health US, LLC1efe378e-fee1-4ae9-8ea5-0fe2265fe2d82020-08-31Warnings, Adverse reactionsExact identifier
application applno (NDA): 016092
application number: NDA016092
ndc (product): 25010-215

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
1251905Edecrin 25 MG Oral TabletPSNcfc43a98-2dc4-4edc-ad49-d2e368ea1bc21
1251903ethacrynic acid 25 MG Oral TabletPSNcfc43a98-2dc4-4edc-ad49-d2e368ea1bc21
1251905ethacrynic acid 25 MG Oral Tablet [Edecrin]SBDcfc43a98-2dc4-4edc-ad49-d2e368ea1bc21
1251903ethacrynic acid 25 MG Oral TabletSCDcfc43a98-2dc4-4edc-ad49-d2e368ea1bc21
1251905Edecrin 25 MG Oral TabletSYcfc43a98-2dc4-4edc-ad49-d2e368ea1bc21

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
25010-215-1525010021515100 TABLET in 1 BOTTLE (25010-215-15) 100 tablet1967-01-100000-00-00NoNoCurrent
25010-215-65250100215656 in 1 BOTTLEHistorical