simvastatin

Product NDC
53808-0794
11-digit product format
538080794
Labeler code
53808
Product ID
53808-0794_eef23738-e47f-4c37-a3b0-fc8f641bb351
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
SIMVASTATIN
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
DOH CENTRAL PHARMACY
Application
ANDA078103
Marketing category
ANDA
Marketing start
2009-07-01
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
No
Listing certified through
2019-12-31
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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53808-0794-1simvastatin30 in 1 BLISTER PACKTABLET, FILM COATED303

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SIMVASTATINACTIVE INGREDIENTAGG2FN16EVSIMVASTATIN TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
SIMVASTATINACTIVE MOIETYAGG2FN16EVSIMVASTATIN TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
ASCORBIC ACIDINACTIVE INGREDIENTPQ6CK8PD0RSIMVASTATIN TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
BUTYLATED HYDROXYANISOLEINACTIVE INGREDIENTREK4960K2USIMVASTATIN TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61USIMVASTATIN TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPSIMVASTATIN TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675SIMVASTATIN TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTSIMVASTATIN TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357SIMVASTATIN TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
HYDROXYPROPYL CELLULOSEINACTIVE INGREDIENTRFW2ET671PSIMVASTATIN TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
HYPROMELLOSEINACTIVE INGREDIENT3NXW29V3WOSIMVASTATIN TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XSIMVASTATIN TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30SIMVASTATIN TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJSIMVASTATIN TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
TALCINACTIVE INGREDIENT7SEV7J4R1USIMVASTATIN TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPSIMVASTATIN TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53808-0794SIMVASTATIN TABLET, FILM COATED [DOH CENTRAL PHARMACY]3Legacy NDC, 1 package rows20170206_7e3fc83f-e322-44a1-b0c3-30e6292b92d9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314231simvastatin 10 MG Oral TabletPSN7e3fc83f-e322-44a1-b0c3-30e6292b92d93
312961simvastatin 20 MG Oral TabletPSN7e3fc83f-e322-44a1-b0c3-30e6292b92d93
198211simvastatin 40 MG Oral TabletPSN7e3fc83f-e322-44a1-b0c3-30e6292b92d93
314231simvastatin 10 MG Oral TabletSCD7e3fc83f-e322-44a1-b0c3-30e6292b92d93
312961simvastatin 20 MG Oral TabletSCD7e3fc83f-e322-44a1-b0c3-30e6292b92d93
198211simvastatin 40 MG Oral TabletSCD7e3fc83f-e322-44a1-b0c3-30e6292b92d93

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
53808-0794-15380807940130 in 1 BLISTER PACKHistorical