Simvastatin

Product NDC
68645-262
11-digit product format
686450262
Labeler code
68645
Product ID
68645-262_7ca18492-8ba1-4b24-97b3-fec147799031
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Simvastatin
Dosage form
TABLET
Route
ORAL
Labeler
Legacy Pharmaceutical Packaging
Application
ANDA077752
Marketing category
ANDA
Marketing start
2010-10-01
Marketing end
0000-00-00
Substance
SIMVASTATIN
Active strength
40 mg/1
Pharmacologic classes
HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]
NDC exclude flag
E
Listing certified through
2018-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
5347abc9-d72b-9efb-f582-cc87efafcf1bProduct name420250729
c4422d73-8e69-1539-606a-32a25fa00ebcProduct name420190926
43d7afbf-e4f7-4bf9-9d8f-6c620b3b3db6Product name120160615
0a5e5249-329b-0cff-e714-77159f193a87Product name120140508

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68645-262-54Simvastatin30 in 1 BOTTLETABLET308

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68645-262-54EA - Each68645-2622b4175b9-c5f0-4c97-b77b-de9c555814c012012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SIMVASTATINACTIVE INGREDIENTAGG2FN16EVSIMVASTATIN TABLET [LEGACY PHARMACEUTICAL PACKAGING]8
SIMVASTATINACTIVE MOIETYAGG2FN16EVSIMVASTATIN TABLET [LEGACY PHARMACEUTICAL PACKAGING]8
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLSIMVASTATIN TABLET [LEGACY PHARMACEUTICAL PACKAGING]8
ASCORBIC ACIDINACTIVE INGREDIENTPQ6CK8PD0RSIMVASTATIN TABLET [LEGACY PHARMACEUTICAL PACKAGING]8
BUTYLATED HYDROXYANISOLEINACTIVE INGREDIENTREK4960K2USIMVASTATIN TABLET [LEGACY PHARMACEUTICAL PACKAGING]8
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61USIMVASTATIN TABLET [LEGACY PHARMACEUTICAL PACKAGING]8
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675SIMVASTATIN TABLET [LEGACY PHARMACEUTICAL PACKAGING]8
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTSIMVASTATIN TABLET [LEGACY PHARMACEUTICAL PACKAGING]8
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357SIMVASTATIN TABLET [LEGACY PHARMACEUTICAL PACKAGING]8
HYDROXYPROPYL CELLULOSEINACTIVE INGREDIENTRFW2ET671PSIMVASTATIN TABLET [LEGACY PHARMACEUTICAL PACKAGING]8
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOSIMVASTATIN TABLET [LEGACY PHARMACEUTICAL PACKAGING]8
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M416302SIMVASTATIN TABLET [LEGACY PHARMACEUTICAL PACKAGING]8
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XSIMVASTATIN TABLET [LEGACY PHARMACEUTICAL PACKAGING]8
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30SIMVASTATIN TABLET [LEGACY PHARMACEUTICAL PACKAGING]8
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJSIMVASTATIN TABLET [LEGACY PHARMACEUTICAL PACKAGING]8
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPSIMVASTATIN TABLET [LEGACY PHARMACEUTICAL PACKAGING]8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68645-262SIMVASTATIN TABLET [LEGACY PHARMACEUTICAL PACKAGING]8Legacy NDC, 1 package rows20120227_e9e50cdb-4cef-4d03-9fb6-973d0c2bf293.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312961simvastatin 20 MG Oral TabletPSNe9e50cdb-4cef-4d03-9fb6-973d0c2bf2938
198211simvastatin 40 MG Oral TabletPSNe9e50cdb-4cef-4d03-9fb6-973d0c2bf2938
312961simvastatin 20 MG Oral TabletSCDe9e50cdb-4cef-4d03-9fb6-973d0c2bf2938
198211simvastatin 40 MG Oral TabletSCDe9e50cdb-4cef-4d03-9fb6-973d0c2bf2938

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
68645-262-546864502625430 in 1 BOTTLEHistorical