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 27 of 154 · 3,079 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Isopropyl alcoholISOPROPYL ALCOHOLMedline Industries, LP2c85e3c0-2876-31c3-e054-00144ff88e882026-02-11WarningsExact identifier
unii: ND2M416302
Isopropyl AlcoholISOPROPYL ALCOHOLMedline Industries, LP52a8b96e-dd4f-449e-b819-6f3ec5a27fb42026-02-11WarningsExact identifier
unii: ND2M416302
Isopropyl AlcoholISOPROPYL ALCOHOLTopco Associates LLCbe4f41bd-8a75-4fb6-8d28-67f6f853e6bd2026-02-11Warnings, Adverse reactionsExact identifier
unii: ND2M416302
70% Isopropyl Rubbing AlcoholISOPROPYL RUBBING ALCOHOLTopco Associates LLC9fbded5f-8dc1-4134-a711-48d1a581d8742026-02-11Warnings, Adverse reactionsExact identifier
unii: ND2M416302
Isopropyl AlcoholISOPROPYL ALCOHOLTopco Associates LLCad1ef2ea-bfc3-4a8a-acd2-55e7f52813d42026-02-11Warnings, Adverse reactionsExact identifier
unii: ND2M416302
SIMVASTATINSIMVASTATINBryant Ranch Prepackaaca7284-d2d8-42e3-b153-ddc3d2ce907c2026-02-10Warnings, Adverse reactionsExact identifier
rxcui: 200345
unii: AGG2FN16EV
Universal ISOPROPYL Rubbing Alcohol 70%ISOPROPYL ALCOHOLUniversal Distribution Center LLC0c76f14b-9a0c-4573-96f2-cd4080eb99e62026-02-10WarningsExact identifier
unii: ND2M416302
70%ISOPROPYL ALCOHOLWalgreen Co.fb918e7a-1fe0-4cfd-8cf0-9d823eb56dcc2026-02-10Warnings, Adverse reactionsExact identifier
unii: ND2M416302
MedlineISOPROPYL ALCOHOLHy-Vee, Inc.4bbce274-1e62-0c6a-e063-6394a90af92f2026-02-10WarningsExact identifier
unii: ND2M416302
Alumier MD Clear Shield Broad Spectrum SPF 42 SunscreenTITANIUM DIOXIDE, ZINC OXIDEAlumier Labsa9c970c8-b6e3-b0a1-e053-2a95a90a89c72026-02-09WarningsExact identifier
unii: 15FIX9V2JP
Youmi Alcohol Prep Pad 70 Isopropyl AlcoholISOPROPYL ALCOHOLPT YOUMI MEDIKA INDUSTRIe3b1a576-a8eb-44bf-8f9c-a49a44a894e82026-02-09WarningsExact identifier
unii: ND2M416302
EVERLIT CARE PRODUCTS PREP PADISOPROPYL ALCOHOLEVERLIT GLOBAL INC.77a60360-8bb5-43e9-b7e4-f71d2d488c442026-02-09WarningsExact identifier
unii: ND2M416302
Everlit Care Products Sting ReliefISOPROPYL ALCOHOLEVERLIT GLOBAL INC.adfab206-b7de-4f6a-a864-edd946ea743d2026-02-09WarningsExact identifier
unii: ND2M416302
AlcoholISOPROPYL ALCOHOLA-S Medication Solutions6b8834be-0235-4f7c-8d52-c2f6aa2d30492026-02-08WarningsExact identifier
unii: ND2M416302
Hampton Sun SPF 50 MineralZINC OXIDE 19.5% TITANIUM DIOXIDE 4.00%S&C Hampton Sun LLCd6c33436-042e-44e8-8b55-98be6e2468792026-02-06WarningsExact identifier
unii: 15FIX9V2JP
SHISEIDO WASO COLOR-SMART DAY MOISTURIZEROCTINOXATE, TITANIUM DIOXIDEShiseido Americas Corporationf291f077-1c72-48fc-bb19-c20bdeaaa5962026-02-06WarningsExact identifier
unii: 15FIX9V2JP
SHISEIDO WASO COLOR-SMART DAY MOISTURIZEROCTINOXATE, TITANIUM DIOXIDEShiseido Americas Corporation54f63dd8-e77f-42e4-a6d3-61ab7beecf502026-02-06WarningsExact identifier
unii: 15FIX9V2JP
Ezetimibe and SimvastatinEZETIMIBE AND SIMVASTATINA-S Medication Solutions2ce219a2-1eeb-4ece-bb87-3810e593ca512026-02-06Warnings, Adverse reactionsExact identifier
unii: AGG2FN16EV
SEYTU Body SunscreenTITANIUM DIOXIDE AND ZINC OXIDEOmnilife USA, Inc.c411e9a6-b2ea-446b-a886-b92c61736e6c2026-02-05WarningsExact identifier
unii: 15FIX9V2JP
SEYTU Facial SunscreenTITANIUM DIOXIDE AND ZINC OXIDEOmnilife USA, Inc.96fd37fb-c3ff-413f-b2c8-50754f320ecc2026-02-05WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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