FDA.reportPublic FDA data

NDC 55154-4782-00 - 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
55154-4782
Requested NDC
55154-4782-00
Package NDCs from labels
55154-4782-0, 55154-4782-00
Manufacturer
Cardinal Health 107, LLC
Effective date
2026-08-25
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Simvastatin - Cardinal Health 107, LLCCardinal Health 107, LLC2026-08-25HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55154-4782-0Simvastatin10 in 1 BAGTABLET, FILM COATED1014
55154-4782-0Simvastatin1 in 1 BLISTER PACKTABLET, FILM COATED114

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55154-4782SIMVASTATIN TABLET, FILM COATED [CARDINAL HEALTH 107, LLC]13Current NDC, Legacy NDC, 2 package rows20240927_b2d6c7ac-304b-4cba-974c-d9a23a069925.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SIMVASTATINACTIVE INGREDIENTAGG2FN16EVSIMVASTATIN TABLET [CARDINAL HEALTH]5
SIMVASTATINACTIVE MOIETYAGG2FN16EVSIMVASTATIN TABLET [CARDINAL HEALTH]5
ASCORBIC ACIDINACTIVE INGREDIENTPQ6CK8PD0RSIMVASTATIN TABLET [CARDINAL HEALTH]5
BUTYLATED HYDROXYANISOLEINACTIVE INGREDIENTREK4960K2USIMVASTATIN TABLET [CARDINAL HEALTH]5
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61USIMVASTATIN TABLET [CARDINAL HEALTH]5
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPSIMVASTATIN TABLET [CARDINAL HEALTH]5
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357SIMVASTATIN TABLET [CARDINAL HEALTH]5
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PSIMVASTATIN TABLET [CARDINAL HEALTH]5
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOSIMVASTATIN TABLET [CARDINAL HEALTH]5
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XSIMVASTATIN TABLET [CARDINAL HEALTH]5
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30SIMVASTATIN TABLET [CARDINAL HEALTH]5
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJSIMVASTATIN TABLET [CARDINAL HEALTH]5
TALCINACTIVE INGREDIENT7SEV7J4R1USIMVASTATIN TABLET [CARDINAL HEALTH]5
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPSIMVASTATIN TABLET [CARDINAL HEALTH]5

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 1 of 122 · 2,426 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30W Aesthetics5b0f2c8f-d6fa-5e25-e063-6394a90a084d2026-09-09WarningsExact identifier
unii: 15FIX9V2JP
ezetimibe and simvastatinEZETIMIBE AND SIMVASTATINNORTHSTAR RX LLC52a46269-2262-4052-a3ff-5455523f591f2026-09-01Warnings, Adverse reactionsExact identifier
unii: AGG2FN16EV
SIMVASTATINSIMVASTATINPreferred Pharmaceuticals, Inc.68f6c856-ea98-4872-b4df-a6e9e70444fc2026-08-31Warnings, Adverse reactionsExact identifier
application number: ANDA078103
unii: AGG2FN16EV
SIMVASTATINSIMVASTATINPreferred Pharmaceuticals, Inc.3f6fad0b-0278-433f-86db-761b673a58032026-08-31Warnings, Adverse reactionsExact identifier
application number: ANDA078103
rxcui: 312961
unii: AGG2FN16EV
SIMVASTATINSIMVASTATINPreferred Pharmaceuticals, Inc.e73ec981-e477-4412-befd-7b807aceb32e2026-08-31Warnings, Adverse reactionsExact identifier
application number: ANDA078103
rxcui: 314231
unii: AGG2FN16EV
SimvastatinSIMVASTATINREMEDYREPACK INC.593f0007-9690-4de5-b1e9-59299e5876432026-08-27Warnings, Adverse reactionsExact identifier
unii: AGG2FN16EV
MZANK SUNSCREEN DAILY ULTIMATE PROTECTION SPF50SUNSCREEN SPF50Guangzhou Meixi Biotechnology Co., Ltd.5a0b4bd2-f6ad-35dc-e063-6294a90a8a662026-08-27WarningsExact identifier
unii: 15FIX9V2JP
MELAO Hydrating Lightweight SunscreenAVOBENZONE,ENSULIZOLE,HOMOSALATE,OCTISALATE,OCTOCRYLENE,TITANIUM DIOXIDEGuangdong Aimu Biological Technology Co., Ltd59eeaea1-d726-99f3-e063-6394a90aeea32026-08-26WarningsExact identifier
unii: 15FIX9V2JP
Q Skin ScienceSUNSCREENInternational Cosmeceuticals, Inc59e4c3d0-ee4c-2350-e063-6394a90ac9d22026-08-25WarningsExact identifier
unii: 15FIX9V2JP
Electrolyte PlusKALI MURIATICUM, L-ARGININE, L-CARNITINE, L-LEUCINE, L-ORNITHINE, L-VALINE, MAGNESIA MURIATICA, ASCORBICUM ACIDUM, BORAX, CHROMIUM OXYDATUM, FERRUM MURIATICUM, KALI CARBONICUM, MAGNESIUM GLUCONICUM DIHYDRICUM, NATRUM MURIATICUM, ZINCUM GLUCONICUM, CUPRUM METALLICUM, KALI PHOSPHORICUM, NICCOLUM METALLICUM, SELENIUM METALLICUM, VANADIUM METALLICUM, CALCAREA CARBONICA, CALCAREA PHOSPHORICA, MANGANUM CARBONICUMDeseret Biologicals, Inc.e3564733-8b88-4753-9077-9d74004d8ec92026-08-25WarningsExact identifier
unii: PQ6CK8PD0R
Mirexa MiniMIREXA MINIOncora Pharma, LLCea48f64a-9a70-40df-ba25-0983532730892026-08-25Warnings, Adverse reactionsExact identifier
unii: PQ6CK8PD0R
SimvastatinSIMVASTATINCardinal Health 107, LLCb2d6c7ac-304b-4cba-974c-d9a23a0699252026-08-25Warnings, Adverse reactionsExact identifier
application number: ANDA078103
ndc (package): 55154-4782-0
ndc (product): 55154-4782
ndc11 (package): 55154478200
rxcui: 312961
spl id: 858506b9-1a8e-49a1-9d2b-d6d81e241676
spl set id: b2d6c7ac-304b-4cba-974c-d9a23a069925
unii: AGG2FN16EV
MELAO zinc stick(GREEN)TITANIUM DIOXIDE,ZINC OXIDE,OCTOCRYLENEGuangzhou Haishi Biological Technology Co., Ltd.59c70c82-f7ff-9a04-e063-6294a90a7b3d2026-08-24WarningsExact identifier
unii: 15FIX9V2JP
SKIN-INFUSED FOUNDATION SPF 25/ Mineral sunscreen broad Spectrum SPF 25 01ZINC OXIDE, TITANIUM DIOXIDECosmuses Cosmetics (Ningbo) Co., Ltd.59d74e3f-e3fa-a7a9-e063-6294a90a76e52026-08-24WarningsExact identifier
unii: 15FIX9V2JP
Rohto All-In-OneHYPROMELLOSE, TETRAHYDROZOLINE HYDROCHLORIDE, ZINC SULFATEThe Mentholatum Company43e690e4-b381-46e3-838c-33aef5bdadde2026-08-20WarningsExact identifier
unii: 3NXW29V3WO
Sweat Resistant Sunscreen Body OriginalTITANIUM DIOXIDE, ZINC OXIDEClutch, Inc.4bbde755-e312-123e-e063-6294a90a467f2026-08-20WarningsExact identifier
unii: 15FIX9V2JP
Ascorbic AcidASCORBIC ACIDRenova Pharmaceuticals LLCa6481bae-2397-44c7-a51d-4f47ad91bd2c2026-08-19Warnings, Adverse reactionsExact identifier
unii: PQ6CK8PD0R
SimvastatinSIMVASTATINREMEDYREPACK INC.d053fee4-b797-4a82-8865-0b4d08b149902026-08-19Warnings, Adverse reactionsExact identifier
rxcui: 312961
unii: AGG2FN16EV
HEADHUNTER SURF SCREEN SPF 50 SUNSCREENZINC OXIDE,TITANIUM DIOXIDEGuangzhou Tata Biotechnology Co., Ltd.4339df13-77d3-31a1-e063-6394a90a52082026-08-17WarningsExact identifier
unii: 15FIX9V2JP
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30HAMBLIN DERMATOLOGY5942e64c-416e-7525-e063-6394a90a28392026-08-17WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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