FDA.reportPublic FDA data

SIMVASTATIN

Product NDC
71335-9630
11-digit product format
713359630
Labeler code
71335
Product ID
71335-9630_b00b4392-0f04-4f1e-92d8-a67a8b132a85
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
2016-02-19
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
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
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
71335-9630-1SIMVASTATIN30 in 1 BOTTLETABLET, FILM COATED30103
71335-9630-2SIMVASTATIN60 in 1 BOTTLETABLET, FILM COATED60103
71335-9630-3SIMVASTATIN90 in 1 BOTTLETABLET, FILM COATED90103
71335-9630-4SIMVASTATIN180 in 1 BOTTLETABLET, FILM COATED180103
71335-9630-5SIMVASTATIN100 in 1 BOTTLETABLET, FILM COATED100103
71335-9630-6SIMVASTATIN120 in 1 BOTTLETABLET, FILM COATED120103
71335-9630-7SIMVASTATIN28 in 1 BOTTLETABLET, FILM COATED28103
71335-9630-8SIMVASTATIN10 in 1 BOTTLETABLET, FILM COATED10103

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-9630SIMVASTATIN TABLET, FILM COATED [BRYANT RANCH PREPACK]102Current NDC, 8 package rows20240830_7abc03f8-9d5f-4f7d-9e32-fc463ec0597c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198211simvastatin 40 MG Oral TabletPSN7abc03f8-9d5f-4f7d-9e32-fc463ec0597c103
198211simvastatin 40 MG Oral TabletSCD7abc03f8-9d5f-4f7d-9e32-fc463ec0597c103

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
71335-9630-17133596300130 TABLET, FILM COATED in 1 BOTTLE (71335-9630-1) 2023-03-08NoNoHistorical
71335-9630-27133596300260 TABLET, FILM COATED in 1 BOTTLE (71335-9630-2) 2026-04-15NoNoHistorical
71335-9630-37133596300390 TABLET, FILM COATED in 1 BOTTLE (71335-9630-3) 2023-02-28NoNoHistorical
71335-9630-471335963004180 TABLET, FILM COATED in 1 BOTTLE (71335-9630-4) 2026-04-15NoNoHistorical
71335-9630-571335963005100 TABLET, FILM COATED in 1 BOTTLE (71335-9630-5) 2023-03-13NoNoHistorical
71335-9630-671335963006120 TABLET, FILM COATED in 1 BOTTLE (71335-9630-6) 2026-04-15NoNoHistorical
71335-9630-77133596300728 TABLET, FILM COATED in 1 BOTTLE (71335-9630-7) 2026-04-15NoNoHistorical
71335-9630-87133596300810 TABLET, FILM COATED in 1 BOTTLE (71335-9630-8) 2026-04-15NoNoHistorical