FDA.reportPublic FDA data

NDC 68071-4996-03 - 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
68071-4996
Requested NDC
68071-4996-03
Package NDCs from labels
68071-4996-3, 68071-4996-9, 68071-4996-03
Manufacturer
NuCare Pharmaceuticals,Inc.
Effective date
2024-06-18
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
simvastatin - NuCare Pharmaceuticals,Inc.NuCare Pharmaceuticals,Inc.2024-06-18HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68071-4996-32021-02-19C16284748780-1ba0f9c33-3c33-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use SIMVASTATIN TABLETS safely and effectively. See full prescribing information for SIMVASTATIN TABLETS. SIMVASTATIN tablets, for oral use Initial U.S. Approval: 1991
68071-4996-32021-01-29C16284748780-1ba0f9c33-3c33-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use SIMVASTATIN TABLETS safely and effectively. See full prescribing information for SIMVASTATIN TABLETS. SIMVASTATIN tablets, for oral use Initial U.S. Approval: 1991

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-4996-3simvastatin30 in 1 BOTTLETABLET, FILM COATED304
68071-4996-9simvastatin90 in 1 BOTTLETABLET, FILM COATED904

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-4996SIMVASTATIN TABLET, FILM COATED [NUCARE PHARMACEUTICALS,INC.]4Current NDC, Legacy NDC, 2 package rows20240620_8ed46bb1-9f84-4418-e053-2a95a90abd4b.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 1 of 123 · 2,451 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
CalamineCALAMINE, PRAMOXINE HCLUnited Natural Foods, Inc. dba UNFI0bc1a9b4-1210-4d9a-bbd2-40e9225e86ea2026-09-04Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
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
rxcui: 200345
unii: AGG2FN16EV
SIMVASTATINSIMVASTATINPreferred Pharmaceuticals, Inc.3f6fad0b-0278-433f-86db-761b673a58032026-08-31Warnings, Adverse reactionsExact identifier
rxcui: 312961
unii: AGG2FN16EV
SIMVASTATINSIMVASTATINPreferred Pharmaceuticals, Inc.e73ec981-e477-4412-befd-7b807aceb32e2026-08-31Warnings, Adverse reactionsExact identifier
rxcui: 314231
unii: AGG2FN16EV
CalamineFERRIC OXIDE REDYour Military Exchangesaf95a66c-f063-4019-80c6-6f7dc4fee4d82026-08-28Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
SimvastatinSIMVASTATINREMEDYREPACK INC.593f0007-9690-4de5-b1e9-59299e5876432026-08-27Warnings, Adverse reactionsExact identifier
rxcui: 312962
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
Calamine PlusCALAMINE, PRAMOXINE HYDROCHLORIDEKroger Company44fdd5a4-3cac-15e5-e063-6294a90adb522026-08-26WarningsExact identifier
unii: 1K09F3G675
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
rxcui: 312961
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
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

Reported adverse events (FAERS/openFDA)#

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