FDA.reportPublic FDA data

NDC 70518-4098-01 - Rosuvastatin

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
70518-4098
Requested NDC
70518-4098-01
Package NDCs from labels
70518-4098-0, 70518-4098-1, 70518-4098-2, 70518-4098-01
Manufacturer
REMEDYREPACK INC.
Effective date
2026-10-19
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Rosuvastatin - REMEDYREPACK INC.REMEDYREPACK INC.2026-10-19HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70518-4098-0Rosuvastatin90 in 1 BOTTLE, PLASTICTABLET, FILM COATED903
70518-4098-1Rosuvastatin30 in 1 BLISTER PACKTABLET, FILM COATED303
70518-4098-2Rosuvastatin90 in 1 BOTTLE, PLASTICTABLET, FILM COATED903

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-4098ROSUVASTATIN TABLET, FILM COATED [REMEDYREPACK INC.]2Current NDC, 3 package rows20240927_6ebaefa9-2c71-4777-8730-83cf5ae737cc.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 99 of 112 · 2,232 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Rosuvastatin calciumROSUVASTATIN CALCIUMBryant Ranch Prepacke41da8b8-db23-49e1-9ee0-55423d2859802023-11-20Warnings, Adverse reactionsExact identifier
rxcui: 859424
Rosuvastatin CalciumROSUVASTATIN CALCIUMBryant Ranch Prepack8795a783-755d-426b-aa4f-1fc9965ba9442023-11-20Warnings, Adverse reactionsExact identifier
rxcui: 859419
Rosuvastatin calciumROSUVASTATIN CALCIUMBryant Ranch Prepack88ab1c85-e864-4879-8489-8365ded78bb52023-11-20Warnings, Adverse reactionsExact identifier
rxcui: 859419
Rosuvastatin CalciumROSUVASTATIN CALCIUMBryant Ranch Prepackadcbfc8c-e4a7-4576-9f0a-42c59c6e2ad12023-11-20Warnings, Adverse reactionsExact identifier
rxcui: 859747
Cetaphil Sheer Mineral Sunscreen SPF 50TITANIUM DIOXIDE, ZINC OXIDEGalderma Laboratories, L.P.581e8289-1406-45b6-9786-753800665fad2023-11-20WarningsExact identifier
unii: 15FIX9V2JP
Rite Aid Mineral Sunscreen Broad Spectrum SPF 50TITANIUM DIOXIDE, ZINC OXIDERite Aid0a4cea12-7e00-d201-e063-6394a90a66912023-11-16WarningsExact identifier
unii: 15FIX9V2JP
Max MineralTITANIUM DIOXIDE, ZINC OXIDEPeter Thomas Roth Labs, LLC0980992c-6488-2fa1-e063-6294a90a41ea2023-11-14WarningsExact identifier
unii: 15FIX9V2JP
Tropical Sands, SPF-50 Broad Spectrum SunscreenTITANIUM DIOXIDE, ZINC OXIDEElements Brands, Inc.493551d0-10a0-3d78-e054-00144ff8d46c2023-11-11WarningsExact identifier
unii: 15FIX9V2JP
Tropical Sands SPF-30 Broad Spectrum SunscreenTITANIUM DIOXIDE, ZINC OXIDEElements Brands, Inc.494a7886-d677-1648-e054-00144ff8d46c2023-11-11WarningsExact identifier
unii: 15FIX9V2JP
Tropical Sands SPF-30 Broad Spectrum SunscreenTITANIUM DIOXIDE, ZINC OXIDEElements Brands, Inc.ab691543-e37a-487a-912e-56d2e0e4d30a2023-11-11WarningsExact identifier
unii: 15FIX9V2JP
PURE HAVEN BODY SPF 30TITANIUM DIOXIDE, ZINC OXIDEPure haven, LLC6f298fcd-8a97-8f66-e053-2991aa0adb102023-11-11WarningsExact identifier
unii: 15FIX9V2JP
Sunstation All-Natural SPF 30 SunscreenTITANIUM DIOXIDE, ZINC OXIDESunstation USA, LLC499d366a-a7f1-6070-e054-00144ff88e882023-11-11WarningsExact identifier
unii: 15FIX9V2JP
Pure Haven EssentialsTITANIUM DIOXIDE, ZINC OXIDEPure Haven LLC4bccc017-266d-11ce-e054-00144ff8d46c2023-11-11WarningsExact identifier
unii: 15FIX9V2JP
koa protect our ocean life OXYBENZONE FREE Broad Spectrum SPF 30 UVA UVB Protection SunscreenTITANIUM DIOXIDE, ZINC OXIDEKapa'ihi, Inc66e5eb1b-4ef0-459d-8428-b3e2f221bc852023-11-11WarningsExact identifier
unii: 15FIX9V2JP
YOU-V SPF-30 Broad Spectrum SunscreenTITANIUM DIOXIDE, ZINC OXIDEYouV, LLC290cd617-aa90-4f10-8a1d-d8954b9270042023-11-11WarningsExact identifier
unii: 15FIX9V2JP
OUTER REEF Reef Safe (WR) Broad Spectrum SPF 30TITANIUM DIOXIDECoral Reef Park Co., Inc.743f3d23-0f5c-4724-9f69-411c109506e12023-11-11WarningsExact identifier
unii: 15FIX9V2JP
ONCODERM Rx Mineral Sunscreen SPF-30TITANIUM DIOXIDE, ZINC OXIDEOncoderm, LLC9f16e832-067c-4ae8-bd7d-6f0dc0ad6fae2023-11-11WarningsExact identifier
unii: 15FIX9V2JP
PROJECT REEF Mineral Sunscreen SPF-50ZINC OXIDE, TITANIUM DIOXIDEProject Reef LLC87b9170c-956e-4aa2-9416-da00cca81b582023-11-11WarningsExact identifier
unii: 15FIX9V2JP
DERMAKA Broad Spectrum SPF-42 SunscreenTITANIUM DIOXIDE, ZINC OXIDEDERMAKA SKIN PRODUCTS32b892fd-c68f-4670-bbaa-0b3de57128492023-11-11WarningsExact identifier
unii: 15FIX9V2JP
WILMA SCHUMANN Moisture Protektiv Day Cream SPF-20OCTINOXATE, OXYBENZONE, TITANIUM DIOXIDESKINMETICS INC4a719986-d1d0-4156-b803-04004b7215042023-11-11WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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