FDA.reportPublic FDA data

Simvastatin

Product NDC
54458-934
11-digit product format
544580934
Labeler code
54458
Product ID
54458-934_3c229a59-320d-4708-bb6b-5a5ff06fb409
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Simvastatin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
International Laboratories, LLC
Application
ANDA076052
Marketing category
ANDA
Marketing start
2010-11-28
Marketing end
0000-00-00
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
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
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
c4422d73-8e69-1539-606a-32a25fa00ebcProduct name420190926
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
43d7afbf-e4f7-4bf9-9d8f-6c620b3b3db6Product name120160615
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
0a5e5249-329b-0cff-e714-77159f193a87Product name120140508
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
54458-934-102021-01-29C16284748780-1ba0f9c33-2ab5-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use SIMVASTATIN TABLETS safely and effectively. See full prescribing information for SIMVASTATIN TABLETS. SIMVASTATIN tablets, for oral use Initial U.S. Approval: 1991
54458-934-162021-01-29C16284748780-1ba0f9c33-2ab5-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use SIMVASTATIN TABLETS safely and effectively. See full prescribing information for SIMVASTATIN TABLETS. SIMVASTATIN tablets, for oral use Initial U.S. Approval: 1991

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54458-934-10Simvastatin30 in 1 BLISTER PACKTABLET, FILM COATED3038
54458-934-16Simvastatin30 in 1 BOTTLETABLET, FILM COATED3038

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
54458-934-10EA - Each54458-93441a01c70-e2b9-41a2-91ce-6729e07bb41412012-07-24
54458-934-16EA - Each54458-93428d4898e-c1b6-4d97-8939-7d1b26f49fb212017-05-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SIMVASTATINACTIVE INGREDIENTAGG2FN16EVSIMVASTATIN TABLET, FILM COATED [INTERNATIONAL LABORATORIES, INC.]32
SIMVASTATINACTIVE MOIETYAGG2FN16EVSIMVASTATIN TABLET, FILM COATED [INTERNATIONAL LABORATORIES, INC.]32
ASCORBIC ACIDINACTIVE INGREDIENTPQ6CK8PD0RSIMVASTATIN TABLET, FILM COATED [INTERNATIONAL LABORATORIES, INC.]32
BUTYLATED HYDROXYANISOLEINACTIVE INGREDIENTREK4960K2USIMVASTATIN TABLET, FILM COATED [INTERNATIONAL LABORATORIES, INC.]32
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61USIMVASTATIN TABLET, FILM COATED [INTERNATIONAL LABORATORIES, INC.]32
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPSIMVASTATIN TABLET, FILM COATED [INTERNATIONAL LABORATORIES, INC.]32
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675SIMVASTATIN TABLET, FILM COATED [INTERNATIONAL LABORATORIES, INC.]32
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTSIMVASTATIN TABLET, FILM COATED [INTERNATIONAL LABORATORIES, INC.]32
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6SIMVASTATIN TABLET, FILM COATED [INTERNATIONAL LABORATORIES, INC.]32
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XSIMVASTATIN TABLET, FILM COATED [INTERNATIONAL LABORATORIES, INC.]32
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30SIMVASTATIN TABLET, FILM COATED [INTERNATIONAL LABORATORIES, INC.]32
POLYETHYLENE GLYCOL 3350INACTIVE INGREDIENTG2M7P15E5PSIMVASTATIN TABLET, FILM COATED [INTERNATIONAL LABORATORIES, INC.]32
POLYETHYLENE GLYCOL 4000INACTIVE INGREDIENT4R4HFI6D95SIMVASTATIN TABLET, FILM COATED [INTERNATIONAL LABORATORIES, INC.]32
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJSIMVASTATIN TABLET, FILM COATED [INTERNATIONAL LABORATORIES, INC.]32
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPSIMVASTATIN TABLET, FILM COATED [INTERNATIONAL LABORATORIES, INC.]32
TRIACETININACTIVE INGREDIENTXHX3C3X673SIMVASTATIN TABLET, FILM COATED [INTERNATIONAL LABORATORIES, INC.]32

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54458-934SIMVASTATIN TABLET, FILM COATED [INTERNATIONAL LABORATORIES, LLC]38Legacy NDC, 2 package rows20191219_1c5178c9-270f-4a5b-a52b-68a56972f035.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314231simvastatin 10 MG Oral TabletPSN1c5178c9-270f-4a5b-a52b-68a56972f03538
312961simvastatin 20 MG Oral TabletPSN1c5178c9-270f-4a5b-a52b-68a56972f03538
198211simvastatin 40 MG Oral TabletPSN1c5178c9-270f-4a5b-a52b-68a56972f03538
314231simvastatin 10 MG Oral TabletSCD1c5178c9-270f-4a5b-a52b-68a56972f03538
312961simvastatin 20 MG Oral TabletSCD1c5178c9-270f-4a5b-a52b-68a56972f03538
198211simvastatin 40 MG Oral TabletSCD1c5178c9-270f-4a5b-a52b-68a56972f03538

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
54458-934-105445809341030 in 1 BLISTER PACKHistorical
54458-934-165445809341630 in 1 BOTTLEHistorical