FDA.reportPublic FDA data

NDC 70518-3349-01 - SIMVASTATIN

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
70518-3349
Requested NDC
70518-3349-01
Package NDCs from labels
70518-3349-1, 70518-3349-0, 70518-3349-2, 70518-3349-3, 70518-3349-01
Manufacturer
REMEDYREPACK INC.
Effective date
2026-08-06
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
SIMVASTATIN - REMEDYREPACK INC.REMEDYREPACK INC.2026-08-06HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70518-3349-0SIMVASTATIN30 in 1 BOXTABLET, FILM COATED3010
70518-3349-1SIMVASTATIN1 in 1 POUCHTABLET, FILM COATED110
70518-3349-2SIMVASTATIN30 in 1 BLISTER PACKTABLET, FILM COATED3010
70518-3349-3SIMVASTATIN90 in 1 BOTTLE, PLASTICTABLET, FILM COATED9010

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-3349SIMVASTATIN TABLET, FILM COATED [REMEDYREPACK INC.]7Current NDC, Legacy NDC, 4 package rows20240704_e59bf31f-d880-4d9e-b6c2-5a18a53718f9.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 97 of 119 · 2,375 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SPF30 Sunscreen CariposaTITANIUM DIOXIDE, ZINC OXIDETalent Brands Company LLC37d696d9-f89d-498e-8fe9-1f08d05d7b612024-04-18WarningsExact identifier
unii: 15FIX9V2JP
Cetaphil Daily Facial Moisturizer with suncreen SPF 50OCTINOXATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE, TITANIUM DIOXIDEGalderma Laboratories, L.P.6650d137-e69e-4ec2-8311-3de74bf213152024-04-17WarningsExact identifier
unii: 15FIX9V2JP
Multitol-MMULTIVITAMIN, FOLATEPureTek Corporation163fdc9e-a405-c3ee-e063-6294a90afd492024-04-17Warnings, Adverse reactionsExact identifier
unii: PQ6CK8PD0R
SPF 30 Mineral Sunscreen CariposaTITANIUM DIOXIDE, ZINC OXIDETalent Brands Company LLC0bc21573-d302-4d85-8d8f-dca9a48e1f352024-04-17WarningsExact identifier
unii: 15FIX9V2JP
Male StimulantARALIA QUINQUEFOLIA, AGNUS CASTUS, ASCORBICUM ACIDUM, CALADIUM SEGUINUM, KALI BROMATUM, CANTHARIS, DAMIANA, FUNICULUS UMBILICALIS SUIS, GLANDULA SUPRARENALIS SUIS, HYPOPHYSIS SUIS, ORCHITINUM (SUIS), PROSTATE (SUIS), STRYCHNINUM PHOSPHORICUM, CONIUM MACULATUM, DIENCEPHALON (SUIS), HEART (SUIS), FERRUM PHOSPHORICUM, MAGNESIA PHOSPHORICA, SELENIUM METALLICUM, ZINCUM METALLICUM, PINEAL GLAND (SUIS), CORTISONE ACETICUM, MANGANUM PHOSPHORICUM, LYCOPODIUM CLAVATUM, TESTOSTERONE, MORGAN GAERTNERDeseret Biologicals, Inc.d48437d6-a54f-4e11-bcfb-9e0d5c1e98da2024-04-15WarningsExact identifier
unii: PQ6CK8PD0R
SimvastatinSIMVASTATINNorthStar Rx LLC0376351b-f1a0-43e5-a0b4-533072c49f392024-04-15Warnings, Adverse reactionsExact identifier
rxcui: 312962
rxcui: 312961
rxcui: 314231
rxcui: 198211
rxcui: 200345
unii: AGG2FN16EV
SimvastatinSIMVASTATINCamber Pharmaceuticals, Inc.751b79c6-bba8-4d29-b69c-a2ac6453fec82024-04-05Warnings, Adverse reactionsExact identifier
rxcui: 312962
rxcui: 312961
rxcui: 314231
rxcui: 198211
rxcui: 200345
unii: AGG2FN16EV
Integra PlusFERROUS FUMARATE AND POLYSACCHRIDE IRON VITAMIN MINERAL COMPLEX SUPPLEMENTU.S. Pharmaceutical Corporation9e5b9309-e835-4863-ab6f-e3018e38fc642024-04-03Warnings, Adverse reactionsExact identifier
unii: PQ6CK8PD0R
RV Illuminance Serum Tint Broad Spectrum 15FACE FOUNDATION WITH SPFREVLON CONSUMER PR Consumer Products Corp132aab60-da19-7079-e063-6394a90a1d762024-03-27WarningsExact identifier
unii: 15FIX9V2JP
RV Illuminance Serum Tint Broad Spectrum 15 AmberFACE FOUNDATION WITH SPFREVLON CONSUMER PR Consumer Products Corp2a0ac71c-e53a-5ff9-e063-6394a90a48072024-03-27WarningsExact identifier
unii: 15FIX9V2JP
EltaMD UV Pure SPF47ZINC OXIDE AND TITANIUM DIOXIDE SUNSCREENCP Skin Health Group, Inc.9afe900b-4186-4189-a871-ad6f26fc26e42024-03-27WarningsExact identifier
unii: 15FIX9V2JP
Pure Cornstarch BabyCORN STARCHWalgreen Companyd0e9bd13-b568-4f7e-b036-8d23e71ad8bf2024-03-25WarningsExact identifier
unii: O8232NY3SJ
SPF 50 Mineral Based Facial SunscreenTITANIUM DIOXIDE, ZINC OXIDEHutton, Kathleen MD5cf0d2e3-d496-424c-ac75-70ff5b87e9ca2024-03-25WarningsExact identifier
unii: 15FIX9V2JP
Daily Prevention Advanced Smartblend Mineral Moisturizer SPF 75TITANIUM DIOXIDE AND ZINC OXIDEAllure Labs141bb721-cd1c-5bba-e063-6394a90ab8fa2024-03-20WarningsExact identifier
unii: 15FIX9V2JP
Sunscreen-LotionZINC OXIDE, TITANIUM DIOXIDEShanghai Chuangshi Medical Technology (Group) Co., Ltd.0511ff57-b7bd-4708-e063-6294a90a58a82024-03-20WarningsExact identifier
unii: 15FIX9V2JP
Daily Prevention Pure Mineral Tinted Moisturizer SPF 30TITANIUM DIOXIDE AND ZINC OXIDEAllure Labs13bc141b-a30f-2661-e063-6294a90aca2b2024-03-15WarningsExact identifier
unii: 15FIX9V2JP
Bio Lymph PhaseTEUCRIUM SCORODONIA, VERONICA OFFICINALIS, EQUISETUM HYEMALE, FUMARIA OFFICINALIS, GERANIUM ROBERTIANUM, NASTURTIUM AQUATICUM, NATRUM SULPHURICUM, PINUS SYLVESTRIS, GENTIANA LUTEA, JUGLANS REGIA, ARANEA DIADEMA, SARSAPARILLA (SMILAX REGELII), ASCORBICUM ACIDUM, QUERCETIN, SCROPHULARIA NODOSA, MYOSOTIS ARVENSIS, CALCAREA PHOSPHORICA, FERRUM IODATUM, THYROIDINUM (SUIS), GAERTNER BACILLUS (BACH)Deseret Biologicals, Inc.b7ba12b8-32e2-4e83-a947-d0a1e91e65d12024-03-15WarningsExact identifier
unii: PQ6CK8PD0R
BB Ambre 30 BS SPF30ZINC OXIDE AND TITANIUM DIOXIDEAllure Labs13a3ec97-0d0a-d639-e063-6294a90a0bf82024-03-14WarningsExact identifier
unii: 15FIX9V2JP
Davimet with FluorideMULTIVITAMIN, FLUORIDEPureTek Corporation11389275-bccb-1293-e063-6394a90aeb4e2024-03-14Warnings, Adverse reactionsExact identifier
unii: PQ6CK8PD0R
Bio Cytotox PhasePODOPHYLLUM PELTATUM, ASCORBICUM ACIDUM, GALIUM APARINE, HYDRASTIS CANADENSIS, NICOTINAMIDUM, PYRIDOXINUM HYDROCHLORICUM, RIBOFLAVINUM, SARCOLACTICUM ACIDUM, THIAMINUM HYDROCHLORICUM, ALPHA-LIPOICUM ACIDUM, COLCHICUM AUTUMNALE, CONIUM MACULATUM, NATRUM OXALACETICUM, SULPHUR, VACCINIUM MYRTILLUS, NOREPINEPHRINE, ACETYLSALICYLICUM ACIDUM, ADENOSINUM TRIPHOSPHORICUM DINATRUM, ANTHRACHINONUM, HISTAMINUM HYDROCHLORICUM, MAGNESIUM GLUCONICUM DIHYDRICUM, NADIDUM, NAPHTHOCHINONUM, PANTOTHENIC ACID, UBIDECARENONUM,Deseret Biologicals, Inc.ca632470-6cbc-4994-a7f0-95b6ad9aa44f2024-03-14WarningsExact identifier
unii: PQ6CK8PD0R

Reported adverse events (FAERS/openFDA)#

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