FDA.reportPublic FDA data

NDC 48433-311-01 - 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
48433-311
Requested NDC
48433-311-01
Package NDCs from labels
48433-311-01, 48433-311-10
Manufacturer
Safecor Health, LLC
Effective date
2014-04-03
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Simvastatin - Safecor Health, LLCSafecor Health, LLC2014-04-03HUMAN PRESCRIPTION DRUG LABEL

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SIMVASTATINACTIVE INGREDIENTAGG2FN16EVSIMVASTATIN TABLET, FILM COATED [SAFECOR HEALTH, LLC]1
SIMVASTATINACTIVE MOIETYAGG2FN16EVSIMVASTATIN TABLET, FILM COATED [SAFECOR HEALTH, LLC]1
ASCORBIC ACIDINACTIVE INGREDIENTPQ6CK8PD0RSIMVASTATIN TABLET, FILM COATED [SAFECOR HEALTH, LLC]1
BUTYLATED HYDROXYANISOLEINACTIVE INGREDIENTREK4960K2USIMVASTATIN TABLET, FILM COATED [SAFECOR HEALTH, LLC]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61USIMVASTATIN TABLET, FILM COATED [SAFECOR HEALTH, LLC]1
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPSIMVASTATIN TABLET, FILM COATED [SAFECOR HEALTH, LLC]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675SIMVASTATIN TABLET, FILM COATED [SAFECOR HEALTH, LLC]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTSIMVASTATIN TABLET, FILM COATED [SAFECOR HEALTH, LLC]1
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PSIMVASTATIN TABLET, FILM COATED [SAFECOR HEALTH, LLC]1
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6SIMVASTATIN TABLET, FILM COATED [SAFECOR HEALTH, LLC]1
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M416302SIMVASTATIN TABLET, FILM COATED [SAFECOR HEALTH, LLC]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XSIMVASTATIN TABLET, FILM COATED [SAFECOR HEALTH, LLC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30SIMVASTATIN TABLET, FILM COATED [SAFECOR HEALTH, LLC]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJSIMVASTATIN TABLET, FILM COATED [SAFECOR HEALTH, LLC]1
TALCINACTIVE INGREDIENT7SEV7J4R1USIMVASTATIN TABLET, FILM COATED [SAFECOR HEALTH, LLC]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPSIMVASTATIN TABLET, FILM COATED [SAFECOR HEALTH, LLC]1

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 89 of 152 · 3,023 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Ferrum rosatum GraphitesFERRUM ROSATUM GRAPHITESUriel Pharmacy Inc.1a4ca338-eada-4c0f-8bce-480244940c892025-06-27WarningsExact identifier
unii: 1K09F3G675
Steritalc 2gTALCNovatech SAc94e51d9-beef-4b06-e053-2a95a90a754a2025-06-25Warnings, Adverse reactionsExact identifier
unii: 7SEV7J4R1U
MELAO WHITENING SUNSCREENTITANIUM DIOXIDEGuangdong Aimu Biological Technology Co., Ltd1aaf5942-ff13-ee07-e063-6394a90acd282025-06-25WarningsExact identifier
unii: PQ6CK8PD0R
unii: 15FIX9V2JP
Good Neighbor Pharmacy Alcohol Antiseptic Skin CleanserISOPROPYL ALCOHOLAmerisouce Bergenfc28cf11-afb9-4295-bee3-735ab10f6bbc2025-06-24WarningsExact identifier
unii: ND2M416302
Meret Sting Relief PadBENZOCAINE, ISOPROPYL ALCOHOLChangzhou Maokang Medical Products Co., Ltd.385def83-38fe-df7f-e063-6394a90abbf02025-06-24WarningsExact identifier
unii: ND2M416302
BISUTANG SunscreenBISUTANG SUNSCREENGuangdong Bisutang Biotechnology Co Ltd37fdb01b-929e-6a60-e063-6394a90a94e02025-06-20Exact identifier
unii: 15FIX9V2JP
Double Use Compact SPF 15 gold deluxe edition Claire 1-2-3OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDEBel Star S.A. (Colombia)b3747373-ef67-89ff-e053-2995a90afcde2025-06-20WarningsExact identifier
unii: 15FIX9V2JP
LBEL DIVINE Double Use compact SPF 15 gold deluxe edition Obscure 8-9ZINC OXIDE, TITANTIUM DIOXIDE, OCTINOXATEBel Star S.A. (Colombia)b5e47c63-7e82-34fc-e053-2a95a90a767c2025-06-20WarningsExact identifier
unii: 15FIX9V2JP
LipBOMBTITANIUM DIOXIDE, ZINC OXIDEFLEUR DE VIE LLC37ef4c1e-2183-a277-e063-6394a90ae2df2025-06-19Exact identifier
unii: 15FIX9V2JP
Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEESTHETICS BY RIKI LLC37f2c5ed-c2f5-e569-e063-6294a90a15b12025-06-19Exact identifier
unii: 15FIX9V2JP
Aloe UP SPF 30 MineralZINC OXIDE, TITANIUM DIOXIDEAloe Care International, LLC35967b33-bdfb-ee3c-e063-6294a90a75f62025-06-18WarningsExact identifier
unii: 15FIX9V2JP
Aloe Up SPF 50 MineralZINC OXIDE, TITANIUM DIOXIDEAloe Care International, LLC35b9dcfa-05f3-3d7b-e063-6394a90a18f12025-06-18WarningsExact identifier
unii: 15FIX9V2JP
Aloe Up SPF 50 Kids MineralZINC OXIDE, TITANIUM DIOXIDEAloe Care International, LLC35cd16b0-bd81-8f68-e063-6294a90a3d8c2025-06-18WarningsExact identifier
unii: 15FIX9V2JP
WISH RUBBING ALCOHOL 99%ISOPROPYL ALCOHOLLJ Pharmaa06953d7-d685-45ac-b1c6-e66dc7a05bca2025-06-18WarningsExact identifier
unii: ND2M416302
Silicone Scar CreamDIMETHICONE, ASCORBIC ACID, TOCOPHEROL, PANTHENOL, ALLANTOINYunqi Cosmetics (Shenzhen) Co., Ltd37d02d8c-fbb5-5ba5-e063-6294a90a43ac2025-06-17WarningsExact identifier
unii: PQ6CK8PD0R
Universal 70% Rubbing Alcohol with Wintergreen and GlycerinISOPROPYL ALCOHOLUniversal Distribution Center LLC1fdff866-f534-4c16-b755-b2efd1e6e8372025-06-17WarningsExact identifier
unii: ND2M416302
Skin by Scottie Beach Mode Mineral Sunscreen Roll-On SPF 30TITANIUM DIOXIDE, ZINC OXIDESKIN CARE BY SCOTTIE LLCa9afa58c-f438-48c6-bd30-eda41334df742025-06-16WarningsExact identifier
unii: 15FIX9V2JP
Dermaka Sunscreen SPF 42, TintedTITANIUM DIOXIDE, ZINC OXIDEDERMAKA SKIN PRODUCTS9a967cd1-9eec-4255-b14b-ac2e33e4dbf02025-06-16WarningsExact identifier
unii: 15FIX9V2JP
WISH RUBBING ALCOHOL 99% WINTERGREENISOPROPYL ALCOHOLLJ Pharmade7b2253-7f36-4a27-8838-442ec635f69b2025-06-16WarningsExact identifier
unii: ND2M416302
WISH RUBBING ALCOHOL 70% WINTERGREENISOPROPYL ALCOHOLLJ Pharma98ebf7a7-7c13-4feb-90b5-21cc6dab99f62025-06-16WarningsExact identifier
unii: ND2M416302

Reported adverse events (FAERS/openFDA)#

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