FDA.reportPublic FDA data

simvastatin

Product NDC
63629-3408
11-digit product format
636293408
Labeler code
63629
Product ID
63629-3408_8898906b-2d01-44bb-9ebc-b7c7f30e11a6
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
80 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
SIMVASTATIN80 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiAGG2FN16EV
Rxcui200345

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63629-3408-12020-10-16C16284748780-19d75b9d0-da5c-f424-e053-dadaa90a57ceThese 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
63629-3408-22020-10-16C16284748780-19d75b9d0-da5c-f424-e053-dadaa90a57ceThese 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
63629-3408-32020-10-16C16284748780-19d75b9d0-da5c-f424-e053-dadaa90a57ceThese 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
63629-3408-42020-10-16C16284748780-19d75b9d0-da5c-f424-e053-dadaa90a57ceThese 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
63629-3408-12020-01-31C16284748780-19d75b9d0-da5c-f424-e053-dadaa90a57ceThese 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
63629-3408-22020-01-31C16284748780-19d75b9d0-da5c-f424-e053-dadaa90a57ceThese 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
63629-3408-32020-01-31C16284748780-19d75b9d0-da5c-f424-e053-dadaa90a57ceThese 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
63629-3408-42020-01-31C16284748780-19d75b9d0-da5c-f424-e053-dadaa90a57ceThese 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
63629-3408-1simvastatin30 in 1 BOTTLETABLET, FILM COATED3011
63629-3408-2simvastatin60 in 1 BOTTLETABLET, FILM COATED6011
63629-3408-3simvastatin90 in 1 BOTTLETABLET, FILM COATED9011
63629-3408-4simvastatin100 in 1 BOTTLETABLET, FILM COATED10011
63629-3408-5simvastatin10 in 1 BOTTLETABLET, FILM COATED1011

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-3408-1EA - Each63629-340822ce5b15-ce8d-49b6-9d80-bffd1367431412012-07-24
63629-3408-2EA - Each63629-34080eedf759-2335-4cc2-b6b0-9d694debfc5512012-07-24
63629-3408-3EA - Each63629-3408cc9010be-44eb-4853-86f1-e6acb43d299e12012-07-24
63629-3408-4EA - Each63629-3408747ddaff-6d17-4ab0-8c84-a425cb37122e12012-07-24

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
63629-3408SIMVASTATIN TABLET, FILM COATED [BRYANT RANCH PREPACK]11Current NDC, Legacy NDC, 5 package rows20240820_b6d5fb21-a1a8-53e5-80d9-dde0eede5ef5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
200345simvastatin 80 MG Oral TabletPSNb6d5fb21-a1a8-53e5-80d9-dde0eede5ef511
200345simvastatin 80 MG Oral TabletSCDb6d5fb21-a1a8-53e5-80d9-dde0eede5ef511

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63629-3408-16362934080130 TABLET, FILM COATED in 1 BOTTLE (63629-3408-1) 2024-08-080000-00-00NoNoCurrent
63629-3408-26362934080260 TABLET, FILM COATED in 1 BOTTLE (63629-3408-2) 2024-08-080000-00-00NoNoCurrent
63629-3408-36362934080390 TABLET, FILM COATED in 1 BOTTLE (63629-3408-3) 2010-09-270000-00-00NoNoCurrent
63629-3408-463629340804100 TABLET, FILM COATED in 1 BOTTLE (63629-3408-4) 2009-02-180000-00-00NoNoCurrent
63629-3408-56362934080510 TABLET, FILM COATED in 1 BOTTLE (63629-3408-5) 2024-08-080000-00-00NoNoCurrent