FDA.reportPublic FDA data

Simvastatin

Product NDC
13107-053
11-digit product format
131070053
Labeler code
13107
Product ID
13107-053_8a37015f-aa57-4a43-9ff0-2ca5540f357d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Simvastatin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Aurolife Pharma LLC
Application
ANDA077691
Marketing category
ANDA
Marketing start
2009-11-09
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
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122
43d7afbf-e4f7-4bf9-9d8f-6c620b3b3db6Product name120160615
0a5e5249-329b-0cff-e714-77159f193a87Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
13107-053-002020-01-31C16284748780-19d75b9d0-b368-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use simvastatin safely and effectively. See full prescribing information for simvastatin tablets. Simvastatin Tablets, USP Initial U.S. Approval: 1991
13107-053-012020-01-31C16284748780-19d75b9d0-b368-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use simvastatin safely and effectively. See full prescribing information for simvastatin tablets. Simvastatin Tablets, USP Initial U.S. Approval: 1991
13107-053-222020-01-31C16284748780-19d75b9d0-b368-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use simvastatin safely and effectively. See full prescribing information for simvastatin tablets. Simvastatin Tablets, USP Initial U.S. Approval: 1991
13107-053-302020-01-31C16284748780-19d75b9d0-b368-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use simvastatin safely and effectively. See full prescribing information for simvastatin tablets. Simvastatin Tablets, USP Initial U.S. Approval: 1991
13107-053-902020-01-31C16284748780-19d75b9d0-b368-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use simvastatin safely and effectively. See full prescribing information for simvastatin tablets. Simvastatin Tablets, USP Initial U.S. Approval: 1991
13107-053-992020-01-31C16284748780-19d75b9d0-b368-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use simvastatin safely and effectively. See full prescribing information for simvastatin tablets. Simvastatin Tablets, USP Initial U.S. Approval: 1991

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
13107-053-00Simvastatin100 in 1 BOTTLETABLET, FILM COATED1006
13107-053-01Simvastatin100 in 1 BOTTLETABLET, FILM COATED1006
13107-053-22Simvastatin2000 in 1 BOTTLETABLET, FILM COATED20006
13107-053-30Simvastatin30 in 1 BOTTLETABLET, FILM COATED306
13107-053-90Simvastatin90 in 1 BOTTLETABLET, FILM COATED906
13107-053-99Simvastatin1000 in 1 BOTTLETABLET, FILM COATED10006

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SIMVASTATINACTIVE INGREDIENTAGG2FN16EVSIMVASTATIN TABLET, FILM COATED [AUROLIFE PHARMA LLC]6
SIMVASTATINACTIVE MOIETYAGG2FN16EVSIMVASTATIN TABLET, FILM COATED [AUROLIFE PHARMA LLC]6
ASCORBIC ACIDINACTIVE INGREDIENTPQ6CK8PD0RSIMVASTATIN TABLET, FILM COATED [AUROLIFE PHARMA LLC]6
BUTYLATED HYDROXYANISOLEINACTIVE INGREDIENTREK4960K2USIMVASTATIN TABLET, FILM COATED [AUROLIFE PHARMA LLC]6
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61USIMVASTATIN TABLET, FILM COATED [AUROLIFE PHARMA LLC]6
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPSIMVASTATIN TABLET, FILM COATED [AUROLIFE PHARMA LLC]6
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675SIMVASTATIN TABLET, FILM COATED [AUROLIFE PHARMA LLC]6
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTSIMVASTATIN TABLET, FILM COATED [AUROLIFE PHARMA LLC]6
HYDROXYPROPYL CELLULOSEINACTIVE INGREDIENTRFW2ET671PSIMVASTATIN TABLET, FILM COATED [AUROLIFE PHARMA LLC]6
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6SIMVASTATIN TABLET, FILM COATED [AUROLIFE PHARMA LLC]6
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M416302SIMVASTATIN TABLET, FILM COATED [AUROLIFE PHARMA LLC]6
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XSIMVASTATIN TABLET, FILM COATED [AUROLIFE PHARMA LLC]6
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30SIMVASTATIN TABLET, FILM COATED [AUROLIFE PHARMA LLC]6
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJSIMVASTATIN TABLET, FILM COATED [AUROLIFE PHARMA LLC]6
TALCINACTIVE INGREDIENT7SEV7J4R1USIMVASTATIN TABLET, FILM COATED [AUROLIFE PHARMA LLC]6
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPSIMVASTATIN TABLET, FILM COATED [AUROLIFE PHARMA LLC]6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
13107-053SIMVASTATIN TABLET, FILM COATED [AUROLIFE PHARMA LLC]6Legacy NDC, 6 package rows20120530_a9415031-0643-42f6-a162-662433fc1071.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314231simvastatin 10 MG Oral TabletPSNa9415031-0643-42f6-a162-662433fc10716
312961simvastatin 20 MG Oral TabletPSNa9415031-0643-42f6-a162-662433fc10716
198211simvastatin 40 MG Oral TabletPSNa9415031-0643-42f6-a162-662433fc10716
312962simvastatin 5 MG Oral TabletPSNa9415031-0643-42f6-a162-662433fc10716
200345simvastatin 80 MG Oral TabletPSNa9415031-0643-42f6-a162-662433fc10716
314231simvastatin 10 MG Oral TabletSCDa9415031-0643-42f6-a162-662433fc10716
312961simvastatin 20 MG Oral TabletSCDa9415031-0643-42f6-a162-662433fc10716
198211simvastatin 40 MG Oral TabletSCDa9415031-0643-42f6-a162-662433fc10716
312962simvastatin 5 MG Oral TabletSCDa9415031-0643-42f6-a162-662433fc10716
200345simvastatin 80 MG Oral TabletSCDa9415031-0643-42f6-a162-662433fc10716

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
13107-053-0013107005300100 in 1 BOTTLEHistorical
13107-053-0113107005301100 in 1 BOTTLEHistorical
13107-053-22131070053222000 in 1 BOTTLEHistorical
13107-053-301310700533030 in 1 BOTTLEHistorical
13107-053-901310700539090 in 1 BOTTLEHistorical
13107-053-99131070053991000 in 1 BOTTLEHistorical