FDA.reportPublic FDA data

simvastatin

Product NDC
63629-3392
11-digit product format
636293392
Labeler code
63629
Product ID
63629-3392_e59ec6f4-bf4f-40b7-b110-65949adf70ef
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
simvastatin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA078155
Marketing category
ANDA
Marketing start
2008-02-26
Substance
SIMVASTATIN
Active strength
10 mg/1
Pharmacologic classes
HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
simvastatin
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SIMVASTATIN10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiAGG2FN16EV
Rxcui314231

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
5347abc9-d72b-9efb-f582-cc87efafcf1bProduct name420250729
c4422d73-8e69-1539-606a-32a25fa00ebcProduct name420190926
43d7afbf-e4f7-4bf9-9d8f-6c620b3b3db6Product name120160615
0a5e5249-329b-0cff-e714-77159f193a87Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63629-3392-1simvastatin30 in 1 BOTTLETABLET, FILM COATED3014
63629-3392-2simvastatin90 in 1 BOTTLETABLET, FILM COATED9014
63629-3392-3simvastatin120 in 1 BOTTLETABLET, FILM COATED12014
63629-3392-4simvastatin100 in 1 BOTTLETABLET, FILM COATED10014
63629-3392-5simvastatin60 in 1 BOTTLETABLET, FILM COATED6014
63629-3392-6simvastatin28 in 1 BOTTLETABLET, FILM COATED2814
63629-3392-7simvastatin10 in 1 BOTTLETABLET, FILM COATED1014

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-3392-1EA - Each63629-3392a19e6123-a3f9-4a2f-b7a3-ce5dbb2ef12212012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SIMVASTATINACTIVE INGREDIENTAGG2FN16EVSIMVASTATIN TABLET, FILM COATED [BRYANT RANCH PREPACK]2
SIMVASTATINACTIVE MOIETYAGG2FN16EVSIMVASTATIN TABLET, FILM COATED [BRYANT RANCH PREPACK]2
ASCORBIC ACIDINACTIVE INGREDIENTPQ6CK8PD0RSIMVASTATIN TABLET, FILM COATED [BRYANT RANCH PREPACK]2
BUTYLATED HYDROXYANISOLEINACTIVE INGREDIENTREK4960K2USIMVASTATIN TABLET, FILM COATED [BRYANT RANCH PREPACK]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61USIMVASTATIN TABLET, FILM COATED [BRYANT RANCH PREPACK]2
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPSIMVASTATIN TABLET, FILM COATED [BRYANT RANCH PREPACK]2
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48SIMVASTATIN TABLET, FILM COATED [BRYANT RANCH PREPACK]2
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675SIMVASTATIN TABLET, FILM COATED [BRYANT RANCH PREPACK]2
HYDROXYPROPYL CELLULOSEINACTIVE INGREDIENTRFW2ET671PSIMVASTATIN TABLET, FILM COATED [BRYANT RANCH PREPACK]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOSIMVASTATIN TABLET, FILM COATED [BRYANT RANCH PREPACK]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XSIMVASTATIN TABLET, FILM COATED [BRYANT RANCH PREPACK]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30SIMVASTATIN TABLET, FILM COATED [BRYANT RANCH PREPACK]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJSIMVASTATIN TABLET, FILM COATED [BRYANT RANCH PREPACK]2
TALCINACTIVE INGREDIENT7SEV7J4R1USIMVASTATIN TABLET, FILM COATED [BRYANT RANCH PREPACK]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPSIMVASTATIN TABLET, FILM COATED [BRYANT RANCH PREPACK]2
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMSIMVASTATIN TABLET, FILM COATED [BRYANT RANCH PREPACK]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-3392SIMVASTATIN TABLET, FILM COATED [BRYANT RANCH PREPACK]14Current NDC, Legacy NDC, 7 package rows20240820_ce3ac5e8-bdef-d195-e0a0-e1a982008efe.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314231simvastatin 10 MG Oral TabletPSNce3ac5e8-bdef-d195-e0a0-e1a982008efe14
314231simvastatin 10 MG Oral TabletSCDce3ac5e8-bdef-d195-e0a0-e1a982008efe14

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63629-3392-16362933920130 TABLET, FILM COATED in 1 BOTTLE (63629-3392-1) 2024-08-080000-00-00NoNoCurrent
63629-3392-26362933920290 TABLET, FILM COATED in 1 BOTTLE (63629-3392-2) 2012-04-180000-00-00NoNoCurrent
63629-3392-363629339203120 TABLET, FILM COATED in 1 BOTTLE (63629-3392-3) 2024-08-080000-00-00NoNoCurrent
63629-3392-463629339204100 TABLET, FILM COATED in 1 BOTTLE (63629-3392-4) 2011-04-250000-00-00NoNoCurrent
63629-3392-56362933920560 TABLET, FILM COATED in 1 BOTTLE (63629-3392-5) 2020-07-130000-00-00NoNoCurrent
63629-3392-66362933920628 TABLET, FILM COATED in 1 BOTTLE (63629-3392-6) 2024-08-080000-00-00NoNoCurrent
63629-3392-76362933920710 TABLET, FILM COATED in 1 BOTTLE (63629-3392-7) 2024-08-080000-00-00NoNoCurrent