FDA.reportPublic FDA data

Simvastatin

Product NDC
55111-197
11-digit product format
551110197
Labeler code
55111
Product ID
55111-197_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
ANDA078425
Marketing category
ANDA
Marketing start
2007-08-16
Marketing end
0000-00-00
Substance
SIMVASTATIN
Active strength
5 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
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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55111-197-05EA - Each55111-197ff2c1398-1762-4cf9-8558-4ed44877b87712012-07-24
55111-197-30EA - Each55111-1976cfb1767-511c-4b99-b2bf-e48ea02b92da12012-07-24
55111-197-90EA - Each55111-197bc29b446-f8a5-4ce1-8a13-0baf7efe1a4b12012-07-24

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, FILM COATED [H.J. HARKINS COMPANY, INC.]1
SimvastatinACTIVE MOIETYAGG2FN16EVSIMVASTATIN TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]1
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLSIMVASTATIN TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]1
ascorbic acidINACTIVE INGREDIENTPQ6CK8PD0RSIMVASTATIN TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]1
BUTYLATED HYDROXYANISOLEINACTIVE INGREDIENTREK4960K2USIMVASTATIN TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61USIMVASTATIN TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675SIMVASTATIN TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTSIMVASTATIN TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]1
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357SIMVASTATIN TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]1
HYDROXYPROPYL CELLULOSEINACTIVE INGREDIENTRFW2ET671PSIMVASTATIN TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]1
hypromellosesINACTIVE INGREDIENT3NXW29V3WOSIMVASTATIN TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]1
isopropyl alcoholINACTIVE INGREDIENTND2M416302SIMVASTATIN TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]1
lactose monohydrateINACTIVE INGREDIENTEWQ57Q8I5XSIMVASTATIN TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]1
magnesium stearateINACTIVE INGREDIENT70097M6I30SIMVASTATIN TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJSIMVASTATIN TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]1
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPSIMVASTATIN TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55111-197SIMVASTATIN 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
312962simvastatin 5 MG Oral TabletPSNb1f2911f-f8e1-41c0-9979-cb8d683d2f2f1
312962simvastatin 5 MG Oral TabletSCDb1f2911f-f8e1-41c0-9979-cb8d683d2f2f1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55111-197-0155111019701100 TABLET, FILM COATED in 1 BOTTLE (55111-197-01) 2007-08-160000-00-00NoNoCurrent
55111-197-0555111019705500 TABLET, FILM COATED in 1 BOTTLE (55111-197-05) 2007-08-160000-00-00NoNoCurrent
55111-197-10551110197101000 TABLET, FILM COATED in 1 BOTTLE (55111-197-10) 2007-08-160000-00-00NoNoCurrent
55111-197-305511101973030 TABLET, FILM COATED in 1 BOTTLE (55111-197-30) 2007-08-160000-00-00NoNoCurrent
55111-197-605511101976060 TABLET, FILM COATED in 1 BOTTLE (55111-197-60) 2007-08-160000-00-00NoNoCurrent
55111-197-785511101977810 DOSE PACK in 1 BOX (55111-197-78) > 10 TABLET, FILM COATED in 1 DOSE PACK10 dose pack2007-08-160000-00-00NoNoCurrent
55111-197-905511101979090 TABLET, FILM COATED in 1 BOTTLE (55111-197-90) 2007-08-160000-00-00NoNoCurrent