FDA.reportPublic FDA data

NDC 70518-4543-2 - Fluoxetine

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
70518-4543
Requested NDC
70518-4543-2
Package NDCs from labels
70518-4543-0, 70518-4543-2, 70518-4543-1, 70518-4543-3
Manufacturer
REMEDYREPACK INC.
Effective date
2026-09-29
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Fluoxetine - REMEDYREPACK INC.REMEDYREPACK INC.2026-09-29HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70518-4543-0Fluoxetine30 in 1 BLISTER PACKCAPSULE302
70518-4543-1Fluoxetine50 in 1 BOXCAPSULE502
70518-4543-2Fluoxetine1 in 1 POUCHCAPSULE12

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 10 of 114 · 2,264 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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
FluoxetineFLUOXETINENorthwind Health Company, LLC50369762-c7c3-d58e-e063-6294a90af8df2026-04-21Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA078619
rxcui: 310384
unii: I9W7N6B1KJ
FluoxetineFLUOXETINE HYDROCHLORIDEPreferred Pharmaceuticals, Inc.ef0fa849-a3a0-45d2-9258-da2d46bee0892026-04-17Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 310384
unii: I9W7N6B1KJ
ELROEL Pang Pang Sun Cushion S7ZINC OXIDE, TITANIUM DIOXIDE, OCTINOXATE, OCTISALATEMONOGLOT HOLDINGS Inc.256bf56f-aefa-47ce-890c-5a3896c11b922026-04-17WarningsExact identifier
unii: 15FIX9V2JP
JUNGSAEMMOOL Essential Skin Nuder Cushion FairTITANIUM DIOXIDE, OCTINOXATE, OCTISALATEJungsaemmool Beauty Co., Ltd.3a43c7c0-7468-4b7a-95b9-f03e37f1b49b2026-04-17WarningsExact identifier
unii: 15FIX9V2JP
JUNGSAEMMOOL Essential Skin Nuder Cushion Fair LightTITANIUM DIOXIDE, OCTINOXATE, OCTISALATEJungsaemmool Beauty Co., Ltd.a251eb20-02e6-4b55-b969-c1bef2f9d7322026-04-17WarningsExact identifier
unii: 15FIX9V2JP
JUNGSAEMMOOL Essential Skin Nuder Cushion Fair PinkTITANIUM DIOXIDE, OCTINOXATE, OCTISALATEJungsaemmool Beauty Co., Ltd.6684d69a-89ff-41e8-81f0-3e2367811a182026-04-17WarningsExact identifier
unii: 15FIX9V2JP
JUNGSAEMMOOL Essential Skin Nuder Cushion LightTITANIUM DIOXIDE, OCTINOXATE, OCTISALATEJungsaemmool Beauty Co., Ltd.bf24d081-85f7-4a26-9416-ecff1fe59dec2026-04-17WarningsExact identifier
unii: 15FIX9V2JP
JUNGSAEMMOOL Essential Skin Nuder Cushion Pink LightTITANIUM DIOXIDE, OCTINOXATE, OCTISALATEJungsaemmool Beauty Co., Ltd.4a09a01a-404f-4b67-91e0-666153f550e82026-04-17WarningsExact identifier
unii: 15FIX9V2JP
JUNGSAEMMOOL Essential Skin Nuder Cushion N-LightTITANIUM DIOXIDE, OCTINOXATE, OCTISALATEJungsaemmool Beauty Co., Ltd.cf7c4445-0382-47ab-aba9-b40d63e4f1cc2026-04-17WarningsExact identifier
unii: 15FIX9V2JP
JUNGSAEMMOOL Essential Skin Nuder Cushion MediumTITANIUM DIOXIDE, OCTINOXATE, OCTISALATEJungsaemmool Beauty Co., Ltd.80c60ffa-69e0-4b31-bd0d-fc8ff9936ba02026-04-17WarningsExact identifier
unii: 15FIX9V2JP
JUNGSAEMMOOL Essential Skin Nuder Cushion Medium DeepTITANIUM DIOXIDE, OCTINOXATE, OCTISALATEJungsaemmool Beauty Co., Ltd.0e18d601-700a-4c1c-a434-22582253bd952026-04-17WarningsExact identifier
unii: 15FIX9V2JP
JUNGSAEMMOOL Essential Skin Nuder Cushion BronzeTITANIUM DIOXIDE, OCTINOXATE, OCTISALATEJungsaemmool Beauty Co., Ltd.ddb3aa5e-cd1a-4792-b1b1-3604b368e0102026-04-17WarningsExact identifier
unii: 15FIX9V2JP
YOUR NAME MINERAL SHEERTINT BROAD SPECTRUM SPF 20-DEEPYOUR NAME MINERAL SHEER TINTPML NYC, LLC0e246e64-2eab-1219-e063-6294a90a79a82026-04-17WarningsExact identifier
unii: 15FIX9V2JP
YOUR NAME MINERAL SHEERTINT BROAD SPECTRUM SPF 20-FAIR GLOWYOUR NAME MINERAL SHEER TINTPML NYC, LLC316cd8a3-3d62-83ac-e063-6394a90a4afa2026-04-17WarningsExact identifier
unii: 15FIX9V2JP
YOUR NAME MINERAL SHEERTINT BROAD SPECTRUM SPF 20- HONEY GLOWYOUR NAME MINERAL SHEER TINTPML NYC, LLC0e2424f4-0011-42b0-e063-6394a90a780d2026-04-17WarningsExact identifier
unii: 15FIX9V2JP
YOUR NAME MINERAL SHEERTINT BROAD SPECTRUM SPF 20-LIGHTYOUR NAME MINERAL SHEER TINTPML NYC, LLC316cfaea-b71f-2956-e063-6294a90a4f202026-04-17WarningsExact identifier
unii: 15FIX9V2JP
YOUR NAME MINERAL SHEERTINT BROAD SPECTRUM SPF 20-MEDIUMYOUR NAME MINERAL SHEER TINTPML NYC, LLC316d1515-6092-a7d6-e063-6394a90ab8b22026-04-17WarningsExact identifier
unii: 15FIX9V2JP
YOUR NAME MINERAL SHEERTINT BROAD SPECTRUM SPF 20- MEDIUM DEEPYOUR NAME MINERAL SHEER TINTPML NYC, LLC0e246e70-6ec3-5711-e063-6394a90a38792026-04-17WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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