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 70 of 152 · 3,034 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
The Green ScissorISOPROPYL ALCOHOL 99%The Green Scissor Incc1fbb53e-b547-0615-e053-2995a90a51512025-12-03WarningsExact identifier
unii: ND2M416302
The Green ScissorISOPROPYL ALCOHOL 99%The Green Scissor Incc1fb4069-b926-266b-e053-2995a90acab92025-12-03WarningsExact identifier
unii: ND2M416302
simvastatinSIMVASTATINQPharma, Inc.c80b823c-b30f-0a9d-e053-2995a90a31e92025-12-03Warnings, Adverse reactionsExact identifier
rxcui: 312961
unii: AGG2FN16EV
CHLORAPREPCHLORAPREPHF Acquisition Co LLC, DBA HealthFirst44fe08e0-4e9c-8bd6-e063-6394a90a0e2b2025-12-02WarningsExact identifier
unii: ND2M416302
JBA Verestor Mega Fiber PowderVITAMIN C,VITAMIN E,INULIN,BANANA STEM EXTRACT,NATTOKINASE,HOUTTUYNIA CORDATA EXTRACT,RUTIN,BETA-CAROTENEAdvanced Pharmaceutical Services, Inc. Dba Affordable Quality Pharmaceuticalse7b861da-3851-4a75-b707-4a427c938ee12025-11-28WarningsExact identifier
unii: PQ6CK8PD0R
Biossance Squalane and Daily Mineral Sunscreen Broad Spectrum SPF 50TITANIUM DIOXIDE, ZINC OXIDETHG Beauty USA LLC44952d01-7f38-0a9c-e063-6394a90a20182025-11-27WarningsExact identifier
unii: 15FIX9V2JP
GLUTATHIONEKOJIC ACIDSKIN LIGHTENINGHANCHOYEANBIOTEC Co.,Ltd.2be274be-e6d0-d961-e063-6294a90a21902025-11-27WarningsExact identifier
unii: PQ6CK8PD0R
SimvastatinSIMVASTATINA-S Medication Solutions468f87c8-75e3-444a-baeb-2d0f629802db2025-11-26Warnings, Adverse reactionsExact identifier
application number: ANDA077691
rxcui: 314231
unii: AGG2FN16EV
salmon colored sunscreenSALMON COLORED SUNSCREENGuangzhou Fantesy Biotechnology Co.,Ltd4477964b-28f3-a371-e063-6294a90a42302025-11-25WarningsExact identifier
unii: 15FIX9V2JP
SimvastatinSIMVASTATINA-S Medication Solutions02245025-218d-4297-aeb6-91fefa1782912025-11-25Warnings, Adverse reactionsExact identifier
application number: ANDA077691
rxcui: 200345
unii: AGG2FN16EV
SimvastatinSIMVASTATINA-S Medication Solutions20fa794a-c30a-485e-9e69-3818ba085a0d2025-11-24Warnings, Adverse reactionsExact identifier
application number: ANDA077691
rxcui: 198211
unii: AGG2FN16EV
SimvastatinSIMVASTATINA-S Medication Solutions9986b59c-aeff-4ccd-8db3-7f1c4e6194202025-11-24Warnings, Adverse reactionsExact identifier
application number: ANDA077691
rxcui: 312961
unii: AGG2FN16EV
SimvastatinSIMVASTATINA-S Medication Solutions7cbf645d-b1d3-413d-a4c3-c1818ed6dfd12025-11-24Warnings, Adverse reactionsExact identifier
application number: ANDA077691
rxcui: 198211
unii: AGG2FN16EV
Sterile alcohol padSTERILE ALCOHOL PADKingstar Medical (Xianning) Co., Ltd.39df5fc7-f66e-1605-e063-6394a90a00542025-11-24WarningsExact identifier
unii: ND2M416302
Ezetimibe and SimvastatinEZETIMIBE AND SIMVASTATINGolden State Medical Supply, Inc.88cd0e7b-e8dc-6125-e053-2a95a90aaa272025-11-24Warnings, Adverse reactionsExact identifier
unii: AGG2FN16EV
it cosmetics Bye Bye Foundation Full Coverage Moisturizer with 3D Skin Flex Broad Spectrum SPF 50 Plus UVA UVB Physical Sunscreen All ShadesTITANIUM DIOXIDE AND ZINC OXIDEL'Oreal USA, Inc.86eea4df-4191-4e05-9f05-4a98ef8c2a4d2025-11-24WarningsExact identifier
unii: 15FIX9V2JP
SimvastatinSIMVASTATINA-S Medication Solutions4312637b-1d6a-4d26-a1e8-caffcd7192df2025-11-24Warnings, Adverse reactionsExact identifier
application number: ANDA077691
rxcui: 312962
unii: AGG2FN16EV
SimvastatinSIMVASTATINA-S Medication Solutionsa2b879ae-eaf3-4a36-abd0-986add4a73ac2025-11-24Warnings, Adverse reactionsExact identifier
application number: ANDA077691
rxcui: 312962
unii: AGG2FN16EV
SimvastatinSIMVASTATINA-S Medication Solutions66777aaa-370a-4121-9246-c0866098f4a42025-11-24Warnings, Adverse reactionsExact identifier
application number: ANDA077691
rxcui: 312961
unii: AGG2FN16EV
SimvastatinSIMVASTATINA-S Medication Solutions658cf877-f7cd-4ec8-84a3-08c27a06ccda2025-11-24Warnings, Adverse reactionsExact identifier
application number: ANDA077691
rxcui: 198211
unii: AGG2FN16EV

Reported adverse events (FAERS/openFDA)#

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