FDA.reportPublic FDA data

Simvastatin

Product NDC
55111-200
11-digit product format
551110200
Labeler code
55111
Product ID
55111-200_84334c5d-1663-972c-5d96-03eb1be16f64
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Simvastatin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Dr. Reddy's Laboratories Limited
Application
ANDA077752
Marketing category
ANDA
Marketing start
2006-12-20
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
2020-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
5347abc9-d72b-9efb-f582-cc87efafcf1bProduct name420250729
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
c4422d73-8e69-1539-606a-32a25fa00ebcProduct name420190926
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122
43d7afbf-e4f7-4bf9-9d8f-6c620b3b3db6Product name120160615
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
0a5e5249-329b-0cff-e714-77159f193a87Product name120140508

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55111-200-05EA - Each55111-200b047bd64-baf8-4aa0-9990-90069703a3a212012-07-24
55111-200-10EA - Each55111-2007219ef7a-6fe8-4817-a4d1-bf9214dbbc2012012-07-24
55111-200-30EA - Each55111-200df0468d4-5307-4a7c-b305-3d6ef3e4bad412012-07-24
55111-200-90EA - Each55111-200d18a95ce-b62b-4895-b75d-fc4b9ff89f3312012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SimvastatinACTIVE INGREDIENTAGG2FN16EVSIMVASTATIN TABLET, FILM COATED [DR. REDDY'S LABORATORIES LIMITED]9
SimvastatinACTIVE MOIETYAGG2FN16EVSIMVASTATIN TABLET, FILM COATED [DR. REDDY'S LABORATORIES LIMITED]9
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLSIMVASTATIN TABLET, FILM COATED [DR. REDDY'S LABORATORIES LIMITED]9
ascorbic acidINACTIVE INGREDIENTPQ6CK8PD0RSIMVASTATIN TABLET, FILM COATED [DR. REDDY'S LABORATORIES LIMITED]9
BUTYLATED HYDROXYANISOLEINACTIVE INGREDIENTREK4960K2USIMVASTATIN TABLET, FILM COATED [DR. REDDY'S LABORATORIES LIMITED]9
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61USIMVASTATIN TABLET, FILM COATED [DR. REDDY'S LABORATORIES LIMITED]9
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675SIMVASTATIN TABLET, FILM COATED [DR. REDDY'S LABORATORIES LIMITED]9
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTSIMVASTATIN TABLET, FILM COATED [DR. REDDY'S LABORATORIES LIMITED]9
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357SIMVASTATIN TABLET, FILM COATED [DR. REDDY'S LABORATORIES LIMITED]9
HYDROXYPROPYL CELLULOSEINACTIVE INGREDIENTRFW2ET671PSIMVASTATIN TABLET, FILM COATED [DR. REDDY'S LABORATORIES LIMITED]9
hypromellosesINACTIVE INGREDIENT3NXW29V3WOSIMVASTATIN TABLET, FILM COATED [DR. REDDY'S LABORATORIES LIMITED]9
isopropyl alcoholINACTIVE INGREDIENTND2M416302SIMVASTATIN TABLET, FILM COATED [DR. REDDY'S LABORATORIES LIMITED]9
lactose monohydrateINACTIVE INGREDIENTEWQ57Q8I5XSIMVASTATIN TABLET, FILM COATED [DR. REDDY'S LABORATORIES LIMITED]9
magnesium stearateINACTIVE INGREDIENT70097M6I30SIMVASTATIN TABLET, FILM COATED [DR. REDDY'S LABORATORIES LIMITED]9
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJSIMVASTATIN TABLET, FILM COATED [DR. REDDY'S LABORATORIES LIMITED]9
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPSIMVASTATIN TABLET, FILM COATED [DR. REDDY'S LABORATORIES LIMITED]9
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
SimvastatinACTIVE INGREDIENTAGG2FN16EVSIMVASTATIN TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA]1
SimvastatinACTIVE INGREDIENTAGG2FN16EVSIMVASTATIN TABLET, FILM COATED [LIFE LINE HOME CARE SERVICES, INC.]1
SimvastatinACTIVE MOIETYAGG2FN16EVSIMVASTATIN TABLET, FILM COATED [LIFE LINE HOME CARE SERVICES, INC.]1
SimvastatinACTIVE MOIETYAGG2FN16EVSIMVASTATIN TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA]1
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLSIMVASTATIN TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA]1
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLSIMVASTATIN TABLET, FILM COATED [LIFE LINE HOME CARE SERVICES, INC.]1
ascorbic acidINACTIVE INGREDIENTPQ6CK8PD0RSIMVASTATIN TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA]1
ascorbic acidINACTIVE INGREDIENTPQ6CK8PD0RSIMVASTATIN TABLET, FILM COATED [LIFE LINE HOME CARE SERVICES, INC.]1
BUTYLATED HYDROXYANISOLEINACTIVE INGREDIENTREK4960K2USIMVASTATIN TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA]1
BUTYLATED HYDROXYANISOLEINACTIVE INGREDIENTREK4960K2USIMVASTATIN TABLET, FILM COATED [LIFE LINE HOME CARE SERVICES, INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61USIMVASTATIN TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61USIMVASTATIN TABLET, FILM COATED [LIFE LINE HOME CARE SERVICES, INC.]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675SIMVASTATIN TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675SIMVASTATIN TABLET, FILM COATED [LIFE LINE HOME CARE SERVICES, INC.]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTSIMVASTATIN TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTSIMVASTATIN TABLET, FILM COATED [LIFE LINE HOME CARE SERVICES, INC.]1
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357SIMVASTATIN TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA]1
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357SIMVASTATIN TABLET, FILM COATED [LIFE LINE HOME CARE SERVICES, INC.]1
HYDROXYPROPYL CELLULOSEINACTIVE INGREDIENTRFW2ET671PSIMVASTATIN TABLET, FILM COATED [LIFE LINE HOME CARE SERVICES, INC.]1
HYDROXYPROPYL CELLULOSEINACTIVE INGREDIENTRFW2ET671PSIMVASTATIN TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA]1
hypromelloseINACTIVE INGREDIENT3NXW29V3WOSIMVASTATIN TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA]1
hypromellosesINACTIVE INGREDIENT3NXW29V3WOSIMVASTATIN TABLET, FILM COATED [LIFE LINE HOME CARE SERVICES, INC.]1
isopropyl alcoholINACTIVE INGREDIENTND2M416302SIMVASTATIN TABLET, FILM COATED [LIFE LINE HOME CARE SERVICES, INC.]1
isopropyl alcoholINACTIVE INGREDIENTND2M416302SIMVASTATIN TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA]1
lactose monohydrateINACTIVE INGREDIENTEWQ57Q8I5XSIMVASTATIN TABLET, FILM COATED [LIFE LINE HOME CARE SERVICES, INC.]1
lactose monohydrateINACTIVE INGREDIENTEWQ57Q8I5XSIMVASTATIN TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA]1
magnesium stearateINACTIVE INGREDIENT70097M6I30SIMVASTATIN TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA]1
magnesium stearateINACTIVE INGREDIENT70097M6I30SIMVASTATIN TABLET, FILM COATED [LIFE LINE HOME CARE SERVICES, INC.]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJSIMVASTATIN TABLET, FILM COATED [LIFE LINE HOME CARE SERVICES, INC.]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJSIMVASTATIN TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA]1
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPSIMVASTATIN TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA]1
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPSIMVASTATIN TABLET, FILM COATED [LIFE LINE HOME CARE SERVICES, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55111-200SIMVASTATIN TABLET, FILM COATED [DR. REDDY'S LABORATORIES LIMITED]14Legacy NDC20190312_d9a1a7c5-d806-4dbd-a201-5e73790d078b.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
198211simvastatin 40 MG Oral TabletPSN6e030b0f-8ee6-4b23-9345-7193d4280e881
198211simvastatin 40 MG Oral TabletSCD6e030b0f-8ee6-4b23-9345-7193d4280e881

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55111-200-0155111020001100 TABLET, FILM COATED in 1 BOTTLE (55111-200-01) 2006-12-200000-00-00NoNoCurrent
55111-200-0555111020005500 TABLET, FILM COATED in 1 BOTTLE (55111-200-05) 2006-12-200000-00-00NoNoCurrent
55111-200-10551110200101000 TABLET, FILM COATED in 1 BOTTLE (55111-200-10) 2006-12-200000-00-00NoNoCurrent
55111-200-305511102003030 TABLET, FILM COATED in 1 BOTTLE (55111-200-30) 2006-12-200000-00-00NoNoCurrent
55111-200-605511102006060 TABLET, FILM COATED in 1 BOTTLE (55111-200-60) 2006-12-200000-00-00NoNoCurrent
55111-200-785511102007810 DOSE PACK in 1 BOX (55111-200-78) > 10 TABLET, FILM COATED in 1 DOSE PACK10 dose pack2006-12-200000-00-00NoNoCurrent
55111-200-905511102009090 TABLET, FILM COATED in 1 BOTTLE (55111-200-90) 2006-12-200000-00-00NoNoCurrent