FDA.reportPublic FDA data

NDC 70518-3838-1 - Fluoxetine Hydrochloride

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
70518-3838
Requested NDC
70518-3838-1
Package NDCs from labels
70518-3838-1, 70518-3838-0
Manufacturer
REMEDYREPACK INC.
Effective date
2025-09-22
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Fluoxetine Hydrochloride - REMEDYREPACK INC.REMEDYREPACK INC.2025-09-22HUMAN PRESCRIPTION DRUG LABEL

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-3838FLUOXETINE HYDROCHLORIDE SOLUTION [REMEDYREPACK INC.]6Unmatched20250101_94e52eb2-5bcb-4f06-9cae-3f13152b7b83.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 2 of 36 · 707 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Topwin Speedy EnemaGLYCERINHealth Chemical Pharmaceutical Co., Ltd3ba8c3d2-1780-42e1-bec5-8f98771d475e2026-07-27WarningsExact identifier
unii: PDC6A3C0OX
Droptics Dry Eye ReliefCARBOXYMETHYLCELLULOSE SODIUM,GLYCERIN,POLYSORBATE 80Droptics LLC29d7614b-f4b7-48e2-97c5-d1bff27731d22026-07-22WarningsExact identifier
unii: PDC6A3C0OX
Sterile WaterWATERCardinal Health 107, LLC9655cd02-82b5-4a75-813b-854b195514812026-07-21Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
FluoxetineFLUOXETINEREMEDYREPACK INC.24926986-7552-4f1a-8366-f035bbd071042026-07-17Boxed warning, Warnings, Adverse reactionsExact identifier
unii: I9W7N6B1KJ
fluoxetine hydrochlorideFLUOXETINE HYDROCHLORIDEBryant Ranch Prepackd4043133-38de-4faa-bb76-8fafa59138442026-07-16Boxed warning, Warnings, Adverse reactionsExact identifier
unii: I9W7N6B1KJ
fluoxetine hydrochlorideFLUOXETINE HYDROCHLORIDEBryant Ranch Prepacka04a5bed-d051-4bb4-ae20-b09b10d5c1812026-07-16Boxed warning, Warnings, Adverse reactionsExact identifier
unii: I9W7N6B1KJ
FluoxetineFLUOXETINE HYDROCHLORIDEAmerican Health Packaging7bee936b-0130-4a6b-a974-956aef5486d92026-07-15Boxed warning, Warnings, Adverse reactionsExact identifier
unii: I9W7N6B1KJ
FluoxetineFLUOXETINEAmerican Health Packaging9965a672-7842-4926-9063-b76317c748622026-07-15Boxed warning, Warnings, Adverse reactionsExact identifier
unii: I9W7N6B1KJ
FluoxetineFLUOXETINEAurobindo Pharma Limiteda9ed97dd-8041-4a02-889c-dcb8b2805f362026-07-15Boxed warning, Warnings, Adverse reactionsExact identifier
unii: I9W7N6B1KJ
FluoxetineFLUOXETINEAurobindo Pharma Limited09fb3100-1e06-4cdc-8016-7e4f5d0974902026-07-15Boxed warning, Warnings, Adverse reactionsExact identifier
unii: I9W7N6B1KJ
FLUOXETINE HYDROCHLORIDEFLUOXETINE HYDROCHLORIDESun Pharmaceutical Industries, Inc.77b6ae48-8e3a-42e6-9b5a-aeed750861e82026-07-14Boxed warning, Warnings, Adverse reactionsExact identifier
unii: I9W7N6B1KJ
fluoxetine hydrochlorideFLUOXETINE HYDROCHLORIDEBryant Ranch Prepackfb0608d9-1ae3-43be-8a20-e9f34e9558622026-07-13Boxed warning, Warnings, Adverse reactionsExact identifier
unii: I9W7N6B1KJ
fluoxetine hydrochlorideFLUOXETINE HYDROCHLORIDEBryant Ranch Prepackd5a267cb-08bd-4530-a7a8-2bceddd828e52026-07-13Boxed warning, Warnings, Adverse reactionsExact identifier
unii: I9W7N6B1KJ
fluoxetine hydrochlorideFLUOXETINE HYDROCHLORIDEBryant Ranch Prepack72e391aa-1a46-4589-8550-f83ac9241cf12026-07-13Boxed warning, Warnings, Adverse reactionsExact identifier
unii: I9W7N6B1KJ
Freskaro Ear Drops for SwimmersFRESKARO EAR DROPS FOR SWIMMERSPharma Nobis, LLC4f724d85-cd38-41da-e063-6394a90a9fd72026-07-08WarningsExact identifier
unii: PDC6A3C0OX
Artificial TearsARTIFICIAL TEARSAvPAKf18bebf2-1936-658f-e053-2a95a90a50122026-07-07WarningsExact identifier
unii: PDC6A3C0OX
Dr. Drop NMN Vital Balance (Drop No.1 Cream 90g)NMN (NICOTINAMIDE MONONUCLEOTIDE), ECTOIN (ECTOINE)Reedfresh Co., LTD55d703ca-ff9d-0dbc-e063-6294a90ab6b12026-07-05WarningsExact identifier
unii: PDC6A3C0OX
unii: 059QF0KO0R
FluoxetineFLUOXETINE HYDROCHLORIDEREMEDYREPACK INC.32afb28a-dc4c-4a7e-9701-1825f805e7df2026-07-03Boxed warning, Warnings, Adverse reactionsExact identifier
unii: I9W7N6B1KJ
Eyesaline Eyewash ConcentratePURIFIED WATERProtective Industrial Products, Inc.558e5926-9027-d3f6-e063-6294a90ab1212026-07-02WarningsExact identifier
unii: 059QF0KO0R
Fendall 2000 Pure FlowPURIFIED WATERProtective Industrial Products, Inc.55a1d07e-0006-0c75-e063-6394a90a7acc2026-07-02WarningsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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