FDA.reportPublic FDA data

simvastatin

Product NDC
63629-3385
11-digit product format
636293385
Labeler code
63629
Product ID
63629-3385_cdc60a7b-745c-4fd8-b2b2-119faba93348
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
40 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
SIMVASTATIN40 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiAGG2FN16EV
Rxcui198211

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
63629-3385-1simvastatin30 in 1 BOTTLETABLET, FILM COATED301019
63629-3385-2simvastatin60 in 1 BOTTLETABLET, FILM COATED601019
63629-3385-3simvastatin90 in 1 BOTTLETABLET, FILM COATED901019
63629-3385-4simvastatin180 in 1 BOTTLETABLET, FILM COATED1801019
63629-3385-5simvastatin100 in 1 BOTTLETABLET, FILM COATED1001019
63629-3385-6simvastatin120 in 1 BOTTLETABLET, FILM COATED1201019
63629-3385-7simvastatin28 in 1 BOTTLETABLET, FILM COATED281019
63629-3385-8simvastatin10 in 1 BOTTLETABLET, FILM COATED101019

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-3385-1EA - Each63629-3385e474f10c-b670-4fed-9d25-4f877a4f23ef12013-02-13
63629-3385-2EA - Each63629-3385b161cbf5-6831-4c0d-8daf-c5220d8e093312013-02-13
63629-3385-3EA - Each63629-3385ed87111d-f800-4957-b064-47618869319212013-02-13
63629-3385-4EA - Each63629-33854228277e-4348-4fbb-9b33-e6695d8aafd512013-02-13
63629-3385-5EA - Each63629-33856310f555-ce42-42ea-af73-587c418d3f3f12013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SIMVASTATINACTIVE INGREDIENTAGG2FN16EVSIMVASTATIN TABLET, FILM COATED [BRYANT RANCH PREPACK]1000
SIMVASTATINACTIVE MOIETYAGG2FN16EVSIMVASTATIN TABLET, FILM COATED [BRYANT RANCH PREPACK]1000
ASCORBIC ACIDINACTIVE INGREDIENTPQ6CK8PD0RSIMVASTATIN TABLET, FILM COATED [BRYANT RANCH PREPACK]1000
BUTYLATED HYDROXYANISOLEINACTIVE INGREDIENTREK4960K2USIMVASTATIN TABLET, FILM COATED [BRYANT RANCH PREPACK]1000
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61USIMVASTATIN TABLET, FILM COATED [BRYANT RANCH PREPACK]1000
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPSIMVASTATIN TABLET, FILM COATED [BRYANT RANCH PREPACK]1000
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48SIMVASTATIN TABLET, FILM COATED [BRYANT RANCH PREPACK]1000
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675SIMVASTATIN TABLET, FILM COATED [BRYANT RANCH PREPACK]1000
HYDROXYPROPYL CELLULOSEINACTIVE INGREDIENTRFW2ET671PSIMVASTATIN TABLET, FILM COATED [BRYANT RANCH PREPACK]1000
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOSIMVASTATIN TABLET, FILM COATED [BRYANT RANCH PREPACK]1000
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XSIMVASTATIN TABLET, FILM COATED [BRYANT RANCH PREPACK]1000
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30SIMVASTATIN TABLET, FILM COATED [BRYANT RANCH PREPACK]1000
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJSIMVASTATIN TABLET, FILM COATED [BRYANT RANCH PREPACK]1000
TALCINACTIVE INGREDIENT7SEV7J4R1USIMVASTATIN TABLET, FILM COATED [BRYANT RANCH PREPACK]1000
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPSIMVASTATIN TABLET, FILM COATED [BRYANT RANCH PREPACK]1000
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMSIMVASTATIN TABLET, FILM COATED [BRYANT RANCH PREPACK]1000

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-3385SIMVASTATIN TABLET, FILM COATED [BRYANT RANCH PREPACK]1019Current NDC, Legacy NDC, 8 package rows20240820_356ed6a6-e467-4791-87ff-2ae7779fc1b0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198211simvastatin 40 MG Oral TabletPSN356ed6a6-e467-4791-87ff-2ae7779fc1b01019
198211simvastatin 40 MG Oral TabletSCD356ed6a6-e467-4791-87ff-2ae7779fc1b01019

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63629-3385-16362933850130 TABLET, FILM COATED in 1 BOTTLE (63629-3385-1) 2024-08-080000-00-00NoNoCurrent
63629-3385-26362933850260 TABLET, FILM COATED in 1 BOTTLE (63629-3385-2) 2009-06-150000-00-00NoNoCurrent
63629-3385-36362933850390 TABLET, FILM COATED in 1 BOTTLE (63629-3385-3) 2010-02-160000-00-00NoNoCurrent
63629-3385-463629338504180 TABLET, FILM COATED in 1 BOTTLE (63629-3385-4) 2011-10-120000-00-00NoNoCurrent
63629-3385-563629338505100 TABLET, FILM COATED in 1 BOTTLE (63629-3385-5) 2008-10-210000-00-00NoNoCurrent
63629-3385-663629338506120 TABLET, FILM COATED in 1 BOTTLE (63629-3385-6) 2024-08-080000-00-00NoNoCurrent
63629-3385-76362933850728 TABLET, FILM COATED in 1 BOTTLE (63629-3385-7) 2024-08-080000-00-00NoNoCurrent
63629-3385-86362933850810 TABLET, FILM COATED in 1 BOTTLE (63629-3385-8) 2024-08-080000-00-00NoNoCurrent