FDA.reportPublic FDA data

NDC 70518-3349-1 - 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
70518-3349-1
Package NDCs from labels
70518-3349-1, 70518-3349-0, 70518-3349-2, 70518-3349-3
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 7 of 119 · 2,380 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DRMTLGY Radiance PowderTITANIUM DIOXIDE, ZINC OXIDEDRMTLGY15bda8d5-8c3c-6ba5-e063-6394a90a82d92026-05-21WarningsExact identifier
unii: 15FIX9V2JP
SIMVASTATINSIMVASTATINCoupler LLC5257271e-5c07-4996-e063-6394a90a44242026-05-21Warnings, Adverse reactionsExact identifier
application number: ANDA078103
rxcui: 312961
unii: AGG2FN16EV
SIMVASTATINSIMVASTATINCoupler LLC52573b98-6e51-9753-e063-6294a90ac8c42026-05-21Warnings, Adverse reactionsExact identifier
application number: ANDA078103
rxcui: 198211
unii: AGG2FN16EV
ACD ACITRIC ACID MONOHYDRATE, DEXTROSE MONOHYDRATE, AND TRISODIUM CITRATE DIHYDRATETerumo BCT, Ltd8e255bc7-a120-460a-a32d-43931f8115de2026-05-21Warnings, Adverse reactionsExact identifier
unii: 2968PHW8QP
SkinCeuticals Future Mineral UV Defense Invisble Sunscreen Mineral Filters Broad Spectrum SPF 50TITANIUM DIOXIDE AND ZINC OXIDEL'Oreal USA Products Inc0b92a940-0dd4-4266-bd47-88c27def62c02026-05-20WarningsExact identifier
unii: 15FIX9V2JP
WHITENING SUNSCREENANTI WRINKLEWHITENING SUNSCREENANTI WRINKLEShantou Oushiya Biotechnology Co.,Ltd524384e9-b3f8-4c13-e063-6394a90a89732026-05-20WarningsExact identifier
unii: 15FIX9V2JP
SIMVASTATINSIMVASTATINREMEDYREPACK INC.5ae78a86-ccca-4714-b77e-7bc885b674b52026-05-20Warnings, Adverse reactionsExact identifier
application number: ANDA078103
rxcui: 314231
unii: AGG2FN16EV
IT COSMETICS HELLO SUNSHINE Invisible Sunscreen Broad Spectrum SPF 50 UVA UVB Mineral 50TITANIUM DIOXIDE AND ZINC OXIDEL'Oreal USA Products Inc.fded7dfb-ffb9-4fb0-9511-273e0e1269692026-05-20WarningsExact identifier
unii: 15FIX9V2JP
Freaks of Nature Peak Performance Broad Spectrum SPF 50FREAKS OF NATURE PEAK PERFORMANCE BROAD SPECTRUM SPF 50THE FREAKS OF NATURE, INC.5247187d-a14c-6468-e063-6394a90ace3e2026-05-20WarningsExact identifier
unii: 15FIX9V2JP
SimvastatinSIMVASTATINAphena Pharma Solutions - Tennessee, LLC522d0f7f-f20b-bc17-e063-6294a90a36482026-05-19Warnings, Adverse reactionsExact identifier
rxcui: 314231
unii: AGG2FN16EV
LANCOME PARIS UV EXPERT SUPRA SCREEN MINERAL INVISIBLE SUNSCREEN SPF 50 SERUMTITANIUM DIOXIDE AND ZINC OXIDELOreal USA Products Inc.23cc5ff4-f842-4e3e-ac5c-23dbaf7d39142026-05-15WarningsExact identifier
unii: 15FIX9V2JP
LANCOME PARIS UV EXPERT SUPRA SCREEN MINERAL INVISIBLE SUNSCREEN SPF 50 SERUMTITANIUM DIOXIDE AND ZINC OXIDESICOS ET CIEc688f8e6-2cd2-40db-b03f-90fd74c2d89c2026-05-15WarningsExact identifier
unii: 15FIX9V2JP
Lancome Paris Teint Idole Ultra Wear Breathable Coverage Foundation Broad Spectrum SPF 25 SunscreenOCTINOXATE AND TITANIUM DIOXIDEL'Oreal USA Products Inc7df9dbd2-7db9-4961-819d-e93d14a065c32026-05-15WarningsExact identifier
unii: 15FIX9V2JP
Lancome Paris Teint Idole Ultra Wear Breathable Coverage Foundation Broad Spectrum SPF 25 SunscreenOCTINOXATE AND TITANIUM DIOXIDESICOS ET CIE20efd5fa-3077-4fd4-82d0-ddca946e45282026-05-15WarningsExact identifier
unii: 15FIX9V2JP
MELAO Hydrating Lightweight SunscreenOCTOCRYLENE,HOMOSALATE,ETHYLHEXYL SALICYLATE,PHENYLBENZIMIDAZOLE SULFONIC ACID,BUTYL METHOXYDIBENZOYLMETHANE,TITANIUM DIOXIDEGuangdong Aimu Biological Technology Co., Ltd51c353cb-94c4-e110-e063-6394a90a497e2026-05-14WarningsExact identifier
unii: 15FIX9V2JP
C07 STRONG LIGAMENTS AND JOINTSARNICA MONTANA, ASCORBICUM ACIDUM, BOS TAURUS LYMPH VESSEL, INTERVERTEBRAL FIBROCARTILAGE, BOS TAURUS MESENCHYME, CALCAREA PHOSPHORICA, CARTILAGO SUIS, FORMICUM ACIDUM, LAPIS ALBUS, PINUS MONTANA LEAFY TWIG, RHAMNUS CALIFORNICA, RHUS TOXICODENDRON, RUTA GRAVEOLENS, SILICEA, SUS SCROFA JOINT ENVELOPE, SUS SCROFA LIGAMENT, SUS SCROFA MENISCUS, SUS SCROFA PARATHYROID GLAND, SUS SCROFA VEIN, SYMPHYTUM OFFICINALEApex Energetics Inc.bccf8c83-a6cd-e58c-e053-2a95a90a43d72026-05-13WarningsExact identifier
unii: PQ6CK8PD0R
simvastatinSIMVASTATINPD-Rx Pharmaceuticals, Inc.aa8aed58-691b-472e-8e98-53d0d3f566862026-05-12Warnings, Adverse reactionsExact identifier
rxcui: 314231
unii: AGG2FN16EV
simvastatinSIMVASTATINPD-Rx Pharmaceuticals, Inc.7463b093-c2ee-49c3-a08a-e758de66422a2026-05-12Warnings, Adverse reactionsExact identifier
rxcui: 198211
unii: AGG2FN16EV
simvastatinSIMVASTATINPD-Rx Pharmaceuticals, Inc.c6b610ab-7367-4e61-9b4a-7ebbd1cf3d362026-05-12Warnings, Adverse reactionsExact identifier
rxcui: 200345
unii: AGG2FN16EV
Even Tone Mineral Sunscreen Broad Spectrum SPF 36 Medium - DarkTITANIUM DIOXIDE AND ZINC OXIDESENT, Inc.aedde765-931f-430e-9fc3-d87bde2b78cd2026-05-12WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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