FDA.reportPublic FDA data

NDC 69238-1126-01 - Ethacrynic Acid

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
69238-1126
Requested NDC
69238-1126-01
Package NDCs from labels
69238-1126-1, 69238-1126-01
Manufacturer
Amneal Pharmaceuticals NY LLC | Amneal Pharmaceuticals Private Limited
Effective date
2026-04-14
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Ethacrynic Acid Tablets, USP (25 mg) Rx OnlyAmneal Pharmaceuticals NY LLC | Amneal Pharmaceuticals Private Limited2026-04-14HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69238-1126-1Ethacrynic Acid100 in 1 BOTTLETABLET1006

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69238-1126ETHACRYNIC ACID TABLET [AMNEAL PHARMACEUTICALS NY LLC]5Current NDC, Legacy NDC, 1 package rows20231231_b9bc3907-bfa7-4d9f-90d9-c2097230f7e4.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69238-1126-1EA - Each69238-1126c38bdb99-1c26-465f-ae59-d0560f5f851d12018-11-06

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 ยท 17 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Ethacrynic AcidETHACRYNIC ACIDEdenbridge Pharmaceuticals LLC.de7c25a6-ed00-4ef3-883d-f8841f5dbd022026-08-19Warnings, Adverse reactionsExact identifier
rxcui: 1251903
unii: M5DP350VZV
Ethacrynic AcidETHACRYNIC ACIDUpsher-Smith Laboratories, LLCc0b17629-7e4a-4c9c-9577-4f79045646282026-07-06Warnings, Adverse reactionsExact identifier
rxcui: 1251903
unii: M5DP350VZV
Ethacrynic AcidETHACRYNIC ACIDSt. Mary's Medical Park Pharmacyf4e95ca1-502b-5305-e053-2995a90a5dc72026-06-26Warnings, Adverse reactionsExact identifier
rxcui: 1251903
unii: M5DP350VZV
Caldesene BabySTARCH, CORN AND ZINC OXIDEInsight Pharmaceuticals LLC9f12dee2-7afa-45e9-a729-0fd42bb777152026-04-22WarningsExact identifier
unii: O8232NY3SJ
Caldesene Medicated ProtectingCORNSTARCH AND ZINC OXIDEInsight Pharmaceuticals LLCffc92a0f-a7cf-4a46-b2f1-089df2bbb96b2026-04-22WarningsExact identifier
unii: O8232NY3SJ
Ethacrynic AcidETHACRYNIC ACIDAmneal Pharmaceuticals NY LLCb9bc3907-bfa7-4d9f-90d9-c2097230f7e42026-04-14Warnings, Adverse reactionsExact identifier
application number: ANDA208805
ndc (package): 69238-1126-1
ndc (product): 69238-1126
ndc11 (package): 69238112601
rxcui: 1251903
spl id: 21b6de3e-2431-4f0c-8440-0ac914ce3d9e
spl set id: b9bc3907-bfa7-4d9f-90d9-c2097230f7e4
unii: M5DP350VZV
Lotrimin Daily Sweat and Odor ControlTOPICAL STARCHBayer HealthCare LLC.9ec5c80d-b550-496f-e053-2a95a90a54892026-01-16WarningsExact identifier
unii: O8232NY3SJ
Medicated Cornstarch Baby PowderACTIVE CORN STARCHDavion, Inc.e39032d1-c8cd-4a41-af10-126970b8ad382025-12-29WarningsExact identifier
unii: O8232NY3SJ
Ethacrynic acidETHACRYNIC ACIDTRUPHARMA LLC3b2b6ee1-1859-4b02-9ef2-5bbe6427f61a2025-12-01Warnings, Adverse reactionsExact identifier
rxcui: 1251903
unii: M5DP350VZV
Ethacrynic AcidETHACRYNIC ACIDLupin Pharmaceuticals, Inc.358dd0c5-4d89-403e-9428-a785ec8628692025-10-30Warnings, Adverse reactionsExact identifier
rxcui: 1251903
unii: M5DP350VZV
Steritalc 2gTALCNovatech SAc94e51d9-beef-4b06-e053-2a95a90a754a2025-06-25Warnings, Adverse reactionsExact identifier
unii: 7SEV7J4R1U
SENSITIVE POCKET SUNSENSITIVE POCKET SUNShantou Oushiya Biotechnology Co., Ltd36ac412f-e31f-6906-e063-6394a90a4a3d2025-06-14WarningsExact identifier
unii: 7SEV7J4R1U
Ethacrynic AcidETHACRYNIC ACIDBryant Ranch Prepackfd1b7fb4-fe56-4f2d-860d-bbcea16adfea2025-02-04Warnings, Adverse reactionsExact identifier
rxcui: 1251903
unii: M5DP350VZV
Ethacrynic AcidETHACRYNIC ACIDScieGen Pharmaceuticals Incd400d264-c231-4bdf-8180-eb11ab4e9f292024-12-24Warnings, Adverse reactionsExact identifier
rxcui: 1251903
unii: M5DP350VZV
Pure Cornstarch BabyCORN STARCHWalgreen Companyd0e9bd13-b568-4f7e-b036-8d23e71ad8bf2024-03-25WarningsExact identifier
unii: O8232NY3SJ
ethacrynic acidETHACRYNIC ACIDOceanside Pharmaceuticalsf127598f-e6b3-4c35-800f-76e4217595ae2023-08-31Warnings, Adverse reactionsExact identifier
rxcui: 1251903
unii: M5DP350VZV
EDECRINETHACRYNIC ACIDBausch Health US, LLC1efe378e-fee1-4ae9-8ea5-0fe2265fe2d82020-08-31Warnings, Adverse reactionsExact identifier
rxcui: 1251903
unii: M5DP350VZV

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.