FDA.reportPublic FDA data

Simvastatin

Product NDC
55154-4782
11-digit product format
551544782
Labeler code
55154
Product ID
55154-4782_403c6eb1-a14f-48d9-a329-b1a7a78029b7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Simvastatin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Cardinal Health 107, LLC
Application
ANDA078103
Marketing category
ANDA
Marketing start
2011-05-02
Substance
SIMVASTATIN
Active strength
20 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
SIMVASTATIN20 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiAGG2FN16EV
Rxcui312961

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 Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55154-4782-0Simvastatin10 in 1 BAGTABLET, FILM COATED1014
55154-4782-0Simvastatin1 in 1 BLISTER PACKTABLET, FILM COATED114

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SIMVASTATINACTIVE INGREDIENTAGG2FN16EVSIMVASTATIN TABLET [CARDINAL HEALTH]5
SIMVASTATINACTIVE MOIETYAGG2FN16EVSIMVASTATIN TABLET [CARDINAL HEALTH]5
ASCORBIC ACIDINACTIVE INGREDIENTPQ6CK8PD0RSIMVASTATIN TABLET [CARDINAL HEALTH]5
BUTYLATED HYDROXYANISOLEINACTIVE INGREDIENTREK4960K2USIMVASTATIN TABLET [CARDINAL HEALTH]5
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61USIMVASTATIN TABLET [CARDINAL HEALTH]5
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPSIMVASTATIN TABLET [CARDINAL HEALTH]5
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357SIMVASTATIN TABLET [CARDINAL HEALTH]5
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PSIMVASTATIN TABLET [CARDINAL HEALTH]5
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOSIMVASTATIN TABLET [CARDINAL HEALTH]5
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XSIMVASTATIN TABLET [CARDINAL HEALTH]5
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30SIMVASTATIN TABLET [CARDINAL HEALTH]5
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJSIMVASTATIN TABLET [CARDINAL HEALTH]5
TALCINACTIVE INGREDIENT7SEV7J4R1USIMVASTATIN TABLET [CARDINAL HEALTH]5
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPSIMVASTATIN TABLET [CARDINAL HEALTH]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55154-4782SIMVASTATIN TABLET, FILM COATED [CARDINAL HEALTH 107, LLC]13Current NDC, Legacy NDC, 2 package rows20240927_b2d6c7ac-304b-4cba-974c-d9a23a069925.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312961simvastatin 20 MG Oral TabletPSNb2d6c7ac-304b-4cba-974c-d9a23a06992514
312961simvastatin 20 MG Oral TabletSCDb2d6c7ac-304b-4cba-974c-d9a23a06992514

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55154-4782-05515447820010 BLISTER PACK in 1 BAG (55154-4782-0) / 1 TABLET, FILM COATED in 1 BLISTER PACK10 blister pack2011-05-020000-00-00NoNoCurrent