FDA.reportPublic FDA data

NDC 70518-3068-1 - mycophenolate mofetil

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
70518-3068
Requested NDC
70518-3068-1
Package NDCs from labels
70518-3068-1, 70518-3068-0
Manufacturer
REMEDYREPACK INC.
Effective date
2024-11-14
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
mycophenolate mofetil - REMEDYREPACK INC.REMEDYREPACK INC.2024-11-14HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70518-3068-02023-03-15C16284748780-1f386c64a-1e25-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use MYCOPHENOLATE MOFETIL TABLETS and MYCOPHENOLATE MOFETIL CAPSULES safely and effectively. See full prescribing information for MYCOPHENOLATE MOFETIL TABLETS and MYCOPHENOLATE MOFETIL CAPSULES MYCOPHENOLATE MOFETIL tablets, for oral use MYCOPHENOLATE MOFETIL capsules, for oral use Initial U.S. Approval: 1995
70518-3068-02023-01-30C16284748780-1f386c64a-1e25-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use MYCOPHENOLATE MOFETIL TABLETS and MYCOPHENOLATE MOFETIL CAPSULES safely and effectively. See full prescribing information for MYCOPHENOLATE MOFETIL TABLETS and MYCOPHENOLATE MOFETIL CAPSULES MYCOPHENOLATE MOFETIL tablets, for oral use MYCOPHENOLATE MOFETIL capsules, for oral use Initial U.S. Approval: 1995

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-3068MYCOPHENOLATE MOFETIL CAPSULE [REMEDYREPACK INC.]4Legacy NDC20241116_1b44c6c4-dfb5-47ed-8201-d7173b3b9887.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 4 of 137 · 2,729 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
EltaMD UV RestoreTITANIUM DIOXIDE, ZINC OXIDE SUNSCREENCP Skin Health Group, Inc37fee381-ce6b-4949-9a4a-778aa839fb842026-08-06WarningsExact identifier
unii: 15FIX9V2JP
CellCeptMYCOPHENOLATE MOFETILGenentech, Inc.37241e87-4af4-4dc3-a1aa-ea6f20d8dc402026-08-05Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 199058
rxcui: 200060
unii: 9242ECW6R0
PROHEAL ALCOHOL PREP PADSISOPROPYL ALCOHOLClick Industries LLCd272c1f6-e9c9-4099-9d24-f5aae44082ae2026-08-05WarningsExact identifier
unii: ND2M416302
Tazza Antiseptic Hand WipesISOPROPYL ALCOHOLTazza Brands East Inc.c37c7599-58b6-58bb-e053-2a95a90af1cf2026-08-04WarningsExact identifier
unii: ND2M416302
Luxe Gloss Hydrating Lip Gloss SPF 35-NAKED HONEYOCTOCRYLENE 8%, OCTISALATE 5%, TITANIUM DIOXIDE 6%, ZINC OXIDE 8%Lale Cosmetics LLC581fb0cd-c55d-d562-e063-6394a90a7f112026-08-03WarningsExact identifier
unii: 15FIX9V2JP
EltaMD UV ActiveZINC OXIDE AND TITANIUM DIOXIDE SUNSCREENCP Skin Health Group, Inc39d16479-d491-4c19-aa11-674461687c7b2026-08-03WarningsExact identifier
unii: 15FIX9V2JP
Continuous Correction CreamTITANIUM DIOXIDEBaxter of California, LLC1cbcc648-f2e1-af60-e063-6294a90ad4bb2026-07-31WarningsExact identifier
unii: 15FIX9V2JP
Cover CremeTITANIUM DIOXIDEBaxter of California31f5e8c4-523f-4596-e063-6294a90a6a122026-07-31WarningsExact identifier
unii: 15FIX9V2JP
ADVOCATE Sterile Alcohol Prep PadsISOPROPYL ALCOHOLPHARMA SUPPLY, INCa87dd40d-a9b1-4bb5-acc2-2d00abc2034a2026-07-30WarningsExact identifier
unii: ND2M416302
70% Isopropyl AlcoholISOPROPYL ALCOHOL4 Visions57ac6fef-21de-e214-e063-6394a90a6c9e2026-07-28WarningsExact identifier
unii: ND2M416302
Isopropyl AlcoholISOPROPYL ALCOHOL4 Visions LLC57acc1ff-2564-1e61-e063-6394a90a3c912026-07-28WarningsExact identifier
unii: ND2M416302
Pharma care IPA WipesISOPROPYL ALCOHOLEnviro Specialty Chemicals Inc26ce919a-1765-4b44-9114-24ea7383a9872026-07-24WarningsExact identifier
unii: ND2M416302
ESIKA COLORFIX POLVOS 32H POLVO COMPACTO FACIAL DE ALTA COBERTURA FPS 15 110-COCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDEBEL STAR S.A.575fb2c3-e332-8a3b-e063-6394a90a9fd92026-07-24WarningsExact identifier
unii: 15FIX9V2JP
DOCTOR INKS IPA WIPESISOPROPYL ALCOHOLEnviro Specialty Chemicals Incf65f0ec4-fa2c-487d-a8cc-41cbb8c140a42026-07-24WarningsExact identifier
unii: ND2M416302
True Coast SPF 50 Mineral SunscreenZINC OXIDE 18%, TITANIUM DIOXIDE 6%Foshan Sugar Max Cosmetics CO.,Ltd5379466d-8d14-5fc2-e063-6394a90abd7e2026-07-22WarningsExact identifier
unii: 15FIX9V2JP
CalamineCALAMINE AND ZINC OXIDEMarie's Original Formulas LLC57110309-9a3d-025f-e063-6394a90a015a2026-07-22WarningsExact identifier
unii: 1K09F3G675
Verifine Alcohol SwabsALCOHOL SWABSPromisemed Hangzhou Meditech Co.,LTD.5738a502-c5ab-21b0-e063-6294a90a20a72026-07-22WarningsExact identifier
unii: ND2M416302
KeepGoing Sting Relief PadBENZOCAINE AND ISOPROPYL ALCOHOLJ&A Digital Inc.a630db1b-1674-4659-a60f-56994b0a15642026-07-22WarningsExact identifier
unii: ND2M416302
KeepGoing Alcohol Prep PadISOPROPYL ALCOHOLJ&A Digital Inc.5d1e776b-4027-4d05-b02f-8a2701d7bc7a2026-07-22WarningsExact identifier
unii: ND2M416302
PROVEN MEDICAL TESTING Alcohol Prep PadsISOPROPYL ALCOHOLProven Medical Testing, LLC21e0f7ea-e73e-4461-ab2b-50d456e1d70d2026-07-22WarningsExact identifier
unii: ND2M416302

Reported adverse events (FAERS/openFDA)#

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