FDA.reportPublic FDA data

simvastatin

Product NDC
63629-3393
11-digit product format
636293393
Labeler code
63629
Product ID
63629-3393_ece7e7f4-92e6-4863-9947-3f5996c04624
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
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
63629-3393-1simvastatin30 in 1 BOTTLETABLET, FILM COATED301012
63629-3393-2simvastatin60 in 1 BOTTLETABLET, FILM COATED601012
63629-3393-3simvastatin100 in 1 BOTTLETABLET, FILM COATED1001012
63629-3393-4simvastatin90 in 1 BOTTLETABLET, FILM COATED901012
63629-3393-5simvastatin120 in 1 BOTTLETABLET, FILM COATED1201012
63629-3393-6simvastatin180 in 1 BOTTLETABLET, FILM COATED1801012
63629-3393-7simvastatin3 in 1 BOTTLETABLET, FILM COATED31012
63629-3393-8simvastatin10 in 1 BOTTLETABLET, FILM COATED101012

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-3393-1EA - Each63629-3393761d0ce5-3e70-4afe-84fc-c359f04ba47f12013-02-13
63629-3393-2EA - Each63629-3393005aebc5-ad5d-4c8f-8eb0-37928db6615512013-02-13
63629-3393-3EA - Each63629-3393efb4bf2b-fa92-4310-9ba4-1f8d43652c5812013-02-13
63629-3393-4EA - Each63629-339344988879-713c-445d-98c7-de7cd11e535912013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SIMVASTATINACTIVE INGREDIENTAGG2FN16EVSIMVASTATIN TABLET, FILM COATED [BRYANT RANCH PREPACK]1001
SIMVASTATINACTIVE MOIETYAGG2FN16EVSIMVASTATIN TABLET, FILM COATED [BRYANT RANCH PREPACK]1001
ASCORBIC ACIDINACTIVE INGREDIENTPQ6CK8PD0RSIMVASTATIN TABLET, FILM COATED [BRYANT RANCH PREPACK]1001
BUTYLATED HYDROXYANISOLEINACTIVE INGREDIENTREK4960K2USIMVASTATIN TABLET, FILM COATED [BRYANT RANCH PREPACK]1001
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61USIMVASTATIN TABLET, FILM COATED [BRYANT RANCH PREPACK]1001
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPSIMVASTATIN TABLET, FILM COATED [BRYANT RANCH PREPACK]1001
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48SIMVASTATIN TABLET, FILM COATED [BRYANT RANCH PREPACK]1001
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675SIMVASTATIN TABLET, FILM COATED [BRYANT RANCH PREPACK]1001
HYDROXYPROPYL CELLULOSEINACTIVE INGREDIENTRFW2ET671PSIMVASTATIN TABLET, FILM COATED [BRYANT RANCH PREPACK]1001
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOSIMVASTATIN TABLET, FILM COATED [BRYANT RANCH PREPACK]1001
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XSIMVASTATIN TABLET, FILM COATED [BRYANT RANCH PREPACK]1001
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30SIMVASTATIN TABLET, FILM COATED [BRYANT RANCH PREPACK]1001
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJSIMVASTATIN TABLET, FILM COATED [BRYANT RANCH PREPACK]1001
TALCINACTIVE INGREDIENT7SEV7J4R1USIMVASTATIN TABLET, FILM COATED [BRYANT RANCH PREPACK]1001
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPSIMVASTATIN TABLET, FILM COATED [BRYANT RANCH PREPACK]1001
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMSIMVASTATIN TABLET, FILM COATED [BRYANT RANCH PREPACK]1001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-3393SIMVASTATIN TABLET, FILM COATED [BRYANT RANCH PREPACK]1012Current NDC, Legacy NDC, 8 package rows20240820_79ca09cd-2396-4e50-b159-1f9567115067.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312961simvastatin 20 MG Oral TabletPSN79ca09cd-2396-4e50-b159-1f95671150671012
312961simvastatin 20 MG Oral TabletSCD79ca09cd-2396-4e50-b159-1f95671150671012

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63629-3393-16362933930130 TABLET, FILM COATED in 1 BOTTLE (63629-3393-1) 2024-08-080000-00-00NoNoCurrent
63629-3393-26362933930260 TABLET, FILM COATED in 1 BOTTLE (63629-3393-2) 2024-08-080000-00-00NoNoCurrent
63629-3393-363629339303100 TABLET, FILM COATED in 1 BOTTLE (63629-3393-3) 2008-06-260000-00-00NoNoCurrent
63629-3393-46362933930490 TABLET, FILM COATED in 1 BOTTLE (63629-3393-4) 2009-04-290000-00-00NoNoCurrent
63629-3393-563629339305120 TABLET, FILM COATED in 1 BOTTLE (63629-3393-5) 2012-04-050000-00-00NoNoCurrent
63629-3393-663629339306180 TABLET, FILM COATED in 1 BOTTLE (63629-3393-6) 2015-02-020000-00-00NoNoCurrent
63629-3393-7636293393073 TABLET, FILM COATED in 1 BOTTLE (63629-3393-7) 2024-08-080000-00-00NoNoCurrent
63629-3393-86362933930810 TABLET, FILM COATED in 1 BOTTLE (63629-3393-8) 2024-08-080000-00-00NoNoCurrent