FDA.reportPublic FDA data

simvastatin

Product NDC
63629-7421
11-digit product format
636297421
Labeler code
63629
Product ID
63629-7421_7434ef9e-3509-44c9-a25b-4e3b309f44b9
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
2014-09-12
Substance
SIMVASTATIN
Active strength
5 mg/1
Pharmacologic classes
HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
simvastatin
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SIMVASTATIN5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiAGG2FN16EV
Rxcui312962

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
5347abc9-d72b-9efb-f582-cc87efafcf1bProduct name420250729
c4422d73-8e69-1539-606a-32a25fa00ebcProduct name420190926
43d7afbf-e4f7-4bf9-9d8f-6c620b3b3db6Product name120160615
0a5e5249-329b-0cff-e714-77159f193a87Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63629-7421-1simvastatin30 in 1 BOTTLETABLET, FILM COATED30105
63629-7421-2simvastatin90 in 1 BOTTLETABLET, FILM COATED90105
63629-7421-3simvastatin60 in 1 BOTTLETABLET, FILM COATED60105
63629-7421-4simvastatin10 in 1 BOTTLETABLET, FILM COATED10105

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-7421SIMVASTATIN TABLET, FILM COATED [BRYANT RANCH PREPACK]104Current NDC, Legacy NDC, 4 package rows20240820_c03ab80c-a3ae-4634-a76b-f53740db76f5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312962simvastatin 5 MG Oral TabletPSNc03ab80c-a3ae-4634-a76b-f53740db76f5105
312962simvastatin 5 MG Oral TabletSCDc03ab80c-a3ae-4634-a76b-f53740db76f5105

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63629-7421-16362974210130 TABLET, FILM COATED in 1 BOTTLE (63629-7421-1) 2018-04-040000-00-00NoNoCurrent
63629-7421-26362974210290 TABLET, FILM COATED in 1 BOTTLE (63629-7421-2) 2017-10-230000-00-00NoNoCurrent
63629-7421-36362974210360 TABLET, FILM COATED in 1 BOTTLE (63629-7421-3) 2024-08-080000-00-00NoNoCurrent
63629-7421-46362974210410 TABLET, FILM COATED in 1 BOTTLE (63629-7421-4) 2024-08-080000-00-00NoNoCurrent