FDA.reportPublic FDA data

Simvastatin

Product NDC
65862-053
11-digit product format
658620053
Labeler code
65862
Product ID
65862-053_854ac8f7-cca5-434c-a611-9c1752260d4a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Simvastatin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Aurobindo Pharma Limited
Application
ANDA077691
Marketing category
ANDA
Marketing start
2006-12-20
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Simvastatin
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SIMVASTATIN40 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiAGG2FN16EV
Rxcui198211, 200345, 312961, 312962, 314231

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
5347abc9-d72b-9efb-f582-cc87efafcf1bProduct name420250729
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
c4422d73-8e69-1539-606a-32a25fa00ebcProduct name420190926
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122
43d7afbf-e4f7-4bf9-9d8f-6c620b3b3db6Product name120160615
0a5e5249-329b-0cff-e714-77159f193a87Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65862-053-00Simvastatin100 in 1 BOTTLETABLET, FILM COATED10029
65862-053-01Simvastatin100 in 1 BOTTLETABLET, FILM COATED10029
65862-053-22Simvastatin2000 in 1 BOTTLETABLET, FILM COATED200029
65862-053-30Simvastatin30 in 1 BOTTLETABLET, FILM COATED3029
65862-053-45Simvastatin45 in 1 BOTTLETABLET, FILM COATED4529
65862-053-90Simvastatin90 in 1 BOTTLETABLET, FILM COATED9029
65862-053-99Simvastatin1000 in 1 BOTTLETABLET, FILM COATED100029

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65862-053-22EA - Each65862-053601e2925-0852-40a8-9266-fed62820289412012-07-24
65862-053-30EA - Each65862-05303bbb0b4-94f4-4370-b6d9-500a0c36983c12012-07-24
65862-053-90EA - Each65862-05373cc8cf6-0592-4852-a2fd-22fedda614ec12012-07-24
65862-053-99EA - Each65862-053c28bab63-34e9-4ac9-8c24-a2810d1d1b4c12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SIMVASTATINACTIVE INGREDIENTAGG2FN16EVSIMVASTATIN TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]15
SIMVASTATINACTIVE MOIETYAGG2FN16EVSIMVASTATIN TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]15
ASCORBIC ACIDINACTIVE INGREDIENTPQ6CK8PD0RSIMVASTATIN TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]15
BUTYLATED HYDROXYANISOLEINACTIVE INGREDIENTREK4960K2USIMVASTATIN TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]15
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61USIMVASTATIN TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]15
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPSIMVASTATIN TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]15
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675SIMVASTATIN TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]15
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTSIMVASTATIN TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]15
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PSIMVASTATIN TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]15
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6SIMVASTATIN TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]15
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M416302SIMVASTATIN TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]15
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XSIMVASTATIN TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]15
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30SIMVASTATIN TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]15
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJSIMVASTATIN TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]15
TALCINACTIVE INGREDIENT7SEV7J4R1USIMVASTATIN TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]15
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPSIMVASTATIN TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]15
SIMVASTATINACTIVE INGREDIENTAGG2FN16EVSIMVASTATIN TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
SIMVASTATINACTIVE MOIETYAGG2FN16EVSIMVASTATIN TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
ASCORBIC ACIDINACTIVE INGREDIENTPQ6CK8PD0RSIMVASTATIN TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
BUTYLATED HYDROXYANISOLEINACTIVE INGREDIENTREK4960K2USIMVASTATIN TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61USIMVASTATIN TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPSIMVASTATIN TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675SIMVASTATIN TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTSIMVASTATIN TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PSIMVASTATIN TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6SIMVASTATIN TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M416302SIMVASTATIN TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XSIMVASTATIN TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30SIMVASTATIN TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJSIMVASTATIN TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
TALCINACTIVE INGREDIENT7SEV7J4R1USIMVASTATIN TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPSIMVASTATIN TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65862-053SIMVASTATIN TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]28Current NDC, Legacy NDC, 7 package rows20240104_4724dbb4-3613-4e6a-948f-a43d34f97f06.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314231simvastatin 10 MG Oral TabletPSN4724dbb4-3613-4e6a-948f-a43d34f97f0629
312961simvastatin 20 MG Oral TabletPSN4724dbb4-3613-4e6a-948f-a43d34f97f0629
198211simvastatin 40 MG Oral TabletPSN4724dbb4-3613-4e6a-948f-a43d34f97f0629
312962simvastatin 5 MG Oral TabletPSN4724dbb4-3613-4e6a-948f-a43d34f97f0629
200345simvastatin 80 MG Oral TabletPSN4724dbb4-3613-4e6a-948f-a43d34f97f0629
314231simvastatin 10 MG Oral TabletSCD4724dbb4-3613-4e6a-948f-a43d34f97f0629
312961simvastatin 20 MG Oral TabletSCD4724dbb4-3613-4e6a-948f-a43d34f97f0629
198211simvastatin 40 MG Oral TabletSCD4724dbb4-3613-4e6a-948f-a43d34f97f0629
312962simvastatin 5 MG Oral TabletSCD4724dbb4-3613-4e6a-948f-a43d34f97f0629
200345simvastatin 80 MG Oral TabletSCD4724dbb4-3613-4e6a-948f-a43d34f97f0629
198211simvastatin 40 MG Oral TabletPSN7cbf645d-b1d3-413d-a4c3-c1818ed6dfd13
198211simvastatin 40 MG Oral TabletSCD7cbf645d-b1d3-413d-a4c3-c1818ed6dfd13
198211simvastatin 40 MG Oral TabletPSNa8aba637-1ae6-45b8-bae7-7496a37741ad2
198211simvastatin 40 MG Oral TabletSCDa8aba637-1ae6-45b8-bae7-7496a37741ad2
314231simvastatin 10 MG Oral TabletPSNc20229c8-719f-4950-b878-ba78d3e461ba1
314231simvastatin 10 MG Oral TabletPSNfdcf0255-08d8-441e-be06-c8968ca340b41
198211simvastatin 40 MG Oral TabletPSNc20229c8-719f-4950-b878-ba78d3e461ba1
198211simvastatin 40 MG Oral TabletPSNfdcf0255-08d8-441e-be06-c8968ca340b41
198211simvastatin 40 MG Oral TabletPSN20fa794a-c30a-485e-9e69-3818ba085a0d1
198211simvastatin 40 MG Oral TabletPSN658cf877-f7cd-4ec8-84a3-08c27a06ccda1
314231simvastatin 10 MG Oral TabletSCDc20229c8-719f-4950-b878-ba78d3e461ba1
314231simvastatin 10 MG Oral TabletSCDfdcf0255-08d8-441e-be06-c8968ca340b41
198211simvastatin 40 MG Oral TabletSCDc20229c8-719f-4950-b878-ba78d3e461ba1
198211simvastatin 40 MG Oral TabletSCD658cf877-f7cd-4ec8-84a3-08c27a06ccda1
198211simvastatin 40 MG Oral TabletSCDfdcf0255-08d8-441e-be06-c8968ca340b41
198211simvastatin 40 MG Oral TabletSCD20fa794a-c30a-485e-9e69-3818ba085a0d1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
65862-053-0065862005300100 TABLET, FILM COATED in 1 BOTTLE (65862-053-00) 2006-12-200000-00-00NoNoCurrent
65862-053-0165862005301100 TABLET, FILM COATED in 1 BOTTLE (65862-053-01) 2006-12-200000-00-00NoNoCurrent
65862-053-22658620053222000 TABLET, FILM COATED in 1 BOTTLE (65862-053-22) 2006-12-200000-00-00NoNoCurrent
65862-053-306586200533030 TABLET, FILM COATED in 1 BOTTLE (65862-053-30) 2006-12-200000-00-00NoNoCurrent
65862-053-456586200534545 TABLET, FILM COATED in 1 BOTTLE (65862-053-45) 2006-12-200000-00-00NoNoCurrent
65862-053-906586200539090 TABLET, FILM COATED in 1 BOTTLE (65862-053-90) 2006-12-200000-00-00NoNoCurrent
65862-053-99658620053991000 TABLET, FILM COATED in 1 BOTTLE (65862-053-99) 2006-12-200000-00-00NoNoCurrent