FDA.reportPublic FDA data

SIMVASTATIN

Product NDC
71335-9636
11-digit product format
713359636
Labeler code
71335
Product ID
71335-9636_fc279d6c-74bf-4e4f-9379-d0a2c3ca876f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
SIMVASTATIN
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA078103
Marketing category
ANDA
Marketing start
2007-06-12
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
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
SIMVASTATIN10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiAGG2FN16EV
Rxcui314231

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
71335-9636-1SIMVASTATIN30 in 1 BOTTLETABLET, FILM COATED30103
71335-9636-2SIMVASTATIN90 in 1 BOTTLETABLET, FILM COATED90103
71335-9636-3SIMVASTATIN120 in 1 BOTTLETABLET, FILM COATED120103
71335-9636-4SIMVASTATIN100 in 1 BOTTLETABLET, FILM COATED100103
71335-9636-5SIMVASTATIN60 in 1 BOTTLETABLET, FILM COATED60103
71335-9636-6SIMVASTATIN28 in 1 BOTTLETABLET, FILM COATED28103
71335-9636-7SIMVASTATIN10 in 1 BOTTLETABLET, FILM COATED10103

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-9636SIMVASTATIN TABLET, FILM COATED [BRYANT RANCH PREPACK]102Current NDC, 7 package rows20240412_76ea62f3-4efb-4649-829d-3f0c28d5dae7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314231simvastatin 10 MG Oral TabletPSN76ea62f3-4efb-4649-829d-3f0c28d5dae7103
314231simvastatin 10 MG Oral TabletSCD76ea62f3-4efb-4649-829d-3f0c28d5dae7103

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
71335-9636-17133596360130 TABLET, FILM COATED in 1 BOTTLE (71335-9636-1) 2023-03-13NoNoHistorical
71335-9636-27133596360290 TABLET, FILM COATED in 1 BOTTLE (71335-9636-2) 2023-03-03NoNoHistorical
71335-9636-371335963603120 TABLET, FILM COATED in 1 BOTTLE (71335-9636-3) 2024-04-03NoNoHistorical
71335-9636-471335963604100 TABLET, FILM COATED in 1 BOTTLE (71335-9636-4) 2023-10-19NoNoHistorical
71335-9636-57133596360560 TABLET, FILM COATED in 1 BOTTLE (71335-9636-5) 2024-04-03NoNoHistorical
71335-9636-67133596360628 TABLET, FILM COATED in 1 BOTTLE (71335-9636-6) 2024-04-03NoNoHistorical
71335-9636-77133596360710 TABLET, FILM COATED in 1 BOTTLE (71335-9636-7) 2024-04-03NoNoHistorical