FDA.reportPublic FDA data

NDC 70518-2907-01 - FENOFIBRATE

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
70518-2907
Requested NDC
70518-2907-01
Package NDCs from labels
70518-2907-0, 70518-2907-1, 70518-2907-01
Manufacturer
REMEDYREPACK INC.
Effective date
2026-07-30
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
FENOFIBRATE - REMEDYREPACK INC.REMEDYREPACK INC.2026-07-30HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
EffectiveRelated label
2022-02-09These highlights do not include all the information needed to use FENOFIBRATE TABLETS safely and effectively. See full prescribing information for FENOFIBRATE TABLETS FENOFIBRATE tablets, for oral use Initial U.S. Approval: 1993
2022-02-09These highlights do not include all the information needed to use FENOFIBRATE TABLETS safely and effectively. See full prescribing information for FENOFIBRATE TABLETS FENOFIBRATE tablets, for oral use Initial U.S. Approval: 1993
2022-01-28These highlights do not include all the information needed to use FENOFIBRATE TABLETS safely and effectively. See full prescribing information for FENOFIBRATE TABLETS FENOFIBRATE tablets, for oral use Initial U.S. Approval: 1993
2022-01-28These highlights do not include all the information needed to use FENOFIBRATE TABLETS safely and effectively. See full prescribing information for FENOFIBRATE TABLETS FENOFIBRATE tablets, for oral use Initial U.S. Approval: 1993

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70518-2907-0FENOFIBRATE90 in 1 BOTTLE, PLASTICTABLET908
70518-2907-1FENOFIBRATE90 in 1 BOTTLE, PLASTICTABLET908

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-2907FENOFIBRATE TABLET [REMEDYREPACK INC.]6Current NDC, Legacy NDC, 2 package rows20250406_3b6c5ebd-a8bc-4502-8b66-f4e58914815b.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 19 of 140 · 2,791 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BIO COM 25 ACIDITYNAT PHOS, NAT SULPH, SILICEABM Private Limited3b3c3455-b321-071d-e063-6394a90a01602026-02-17WarningsExact identifier
unii: ETJ7Z6XBU4
FenofibrateFENOFIBRATEBryant Ranch Prepackbbeae8e4-e06a-4c19-a1b9-f6143306dab92026-02-16Warnings, Adverse reactionsExact identifier
rxcui: 349287
unii: U202363UOS
CINAAMBROSIA, CINA, CUCURBITA CIT, CUCURBITA PEP, INDIGO, SANTONINE, SILICEABM PRIVATE LIMITED3b3c0874-90b5-deda-e063-6394a90a78022026-02-15WarningsExact identifier
unii: ETJ7Z6XBU4
Acne/Pimple ControlCALENDULA OFFICINALIS FLOWERING TOP AND SILICON DIOXIDEForces of Naturee871e46e-463e-49ec-a2af-5aa98548ee122026-02-13WarningsExact identifier
unii: ETJ7Z6XBU4
FENOFIBRATEFENOFIBRATEREMEDYREPACK INC.b79efcf4-6016-4a1f-b83f-be00baa25c212026-02-13Warnings, Adverse reactionsExact identifier
application number: ANDA213864
rxcui: 351133
unii: U202363UOS
FuligoCIMICIFUGA, DROSERA, FORMICA RUFA, FULIGO, INULA HEL., KALI MUR, LAPIS ALBUS, SILICEABM Private Limited3b27225f-4587-d915-e063-6294a90a72252026-02-12WarningsExact identifier
unii: ETJ7Z6XBU4
Alumier MD Clear Shield Broad Spectrum SPF 42 SunscreenTITANIUM DIOXIDE, ZINC OXIDEAlumier Labsa9c970c8-b6e3-b0a1-e053-2a95a90a89c72026-02-09WarningsExact identifier
unii: 15FIX9V2JP
Mold, Yeast and DustADRENALINUM, ARSENICUM IODATUM, ASPERGILLUS FLAVUS, ASPERGILLUS FUMIGATUS, ASPERGILLUS GLAUCUS, ASPERGILLUS NIDULANS, ASPERGILLUS NIGER, CANDIDA ALBICANS, DERMATOPHAGOIDES FARINAE, HISTAMINUM HYDROCHLORICUM, LYCOPODIUM CLAVATUM, MUCOR PLUMBEUS, NATRUM SULPHURICUM, PENICILLIUM DIGITATUM, PENICILLIUM ROQUEFORTII, SACCHAROMYCES CEREVISIAE, SILICEANaturalCare32afa0f0-bca5-4246-bc2e-decd757fcf9d2026-02-09WarningsExact identifier
unii: ETJ7Z6XBU4
Hampton Sun SPF 50 MineralZINC OXIDE 19.5% TITANIUM DIOXIDE 4.00%S&C Hampton Sun LLCd6c33436-042e-44e8-8b55-98be6e2468792026-02-06WarningsExact identifier
unii: 15FIX9V2JP
SHISEIDO WASO COLOR-SMART DAY MOISTURIZEROCTINOXATE, TITANIUM DIOXIDEShiseido Americas Corporationf291f077-1c72-48fc-bb19-c20bdeaaa5962026-02-06WarningsExact identifier
unii: 15FIX9V2JP
SHISEIDO WASO COLOR-SMART DAY MOISTURIZEROCTINOXATE, TITANIUM DIOXIDEShiseido Americas Corporation54f63dd8-e77f-42e4-a6d3-61ab7beecf502026-02-06WarningsExact identifier
unii: 15FIX9V2JP
SEYTU Body SunscreenTITANIUM DIOXIDE AND ZINC OXIDEOmnilife USA, Inc.c411e9a6-b2ea-446b-a886-b92c61736e6c2026-02-05WarningsExact identifier
unii: 15FIX9V2JP
SEYTU Facial SunscreenTITANIUM DIOXIDE AND ZINC OXIDEOmnilife USA, Inc.96fd37fb-c3ff-413f-b2c8-50754f320ecc2026-02-05WarningsExact identifier
unii: 15FIX9V2JP
No7 Restore and Renew Multi Action Serum Foundation Sunscreen Broad Spectrum SPF 20 BambooOCTINOXATE, TITANIUM DIOXIDEBCM Cosmetique SASebfe03e7-614f-44b1-b1f1-78edc7e274cc2026-02-05WarningsExact identifier
unii: 15FIX9V2JP
DPT-TOXDROSERA, ECHINACEA, HYPERICUM, KALI MUR, MEZEREUM, SILICEA, THUJANutrition Center Inc dba Nutri-West dba Micro-West5e39f4e6-939f-4b71-9cc5-6d4b8711ea322026-02-04WarningsExact identifier
unii: ETJ7Z6XBU4
FenofibrateFENOFIBRATEBostal LLCedace25a-3296-9ca7-dcb8-d0698f65840d2026-02-04Warnings, Adverse reactionsExact identifier
rxcui: 349287
rxcui: 351133
unii: U202363UOS
SHISEIDO URBAN ENVIRONMENT oil-free MINERAL SUNSCREEN SPF 42TITANIUM DIOXIDE AND ZINC OXIDESHISEIDO AMERICAS CORPORATION86630e82-f249-4866-82dd-3e21feb266c42026-02-04WarningsExact identifier
unii: 15FIX9V2JP
FenofibrateFENOFIBRATEA-S Medication Solutionsd9c60b43-dc61-4976-b31f-09c8f8a331382026-02-04Warnings, Adverse reactionsExact identifier
unii: U202363UOS
Meteoric Iron PrunusMETEORIC IRON PRUNUSUriel Pharmacy Inc.e9020757-2393-4a22-9665-25da0a0993d02026-02-03WarningsExact identifier
unii: ETJ7Z6XBU4
MINIDROPSLUBRICANT EYE DROPSOptics Laboratory, Incc13c5f91-50df-471c-a7c9-1747a2ac12502026-02-03WarningsExact identifier
unii: 532B59J990

Reported adverse events (FAERS/openFDA)#

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