FDA.reportPublic FDA data

SIMVASTATIN

Product NDC
71335-9642
11-digit product format
713359642
Labeler code
71335
Product ID
71335-9642_16a69c73-1437-4b33-b8d6-b549e1040ce5
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
2007-06-14
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
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
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
71335-9642-1SIMVASTATIN30 in 1 BOTTLETABLET, FILM COATED30104
71335-9642-2SIMVASTATIN60 in 1 BOTTLETABLET, FILM COATED60104
71335-9642-3SIMVASTATIN100 in 1 BOTTLETABLET, FILM COATED100104
71335-9642-4SIMVASTATIN90 in 1 BOTTLETABLET, FILM COATED90104
71335-9642-5SIMVASTATIN120 in 1 BOTTLETABLET, FILM COATED120104
71335-9642-6SIMVASTATIN180 in 1 BOTTLETABLET, FILM COATED180104
71335-9642-7SIMVASTATIN3 in 1 BOTTLETABLET, FILM COATED3104
71335-9642-8SIMVASTATIN10 in 1 BOTTLETABLET, FILM COATED10104

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-9642SIMVASTATIN TABLET, FILM COATED [BRYANT RANCH PREPACK]103Current NDC, 8 package rows20240830_5c760852-800b-463e-8059-06a9a82c2225.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312961simvastatin 20 MG Oral TabletPSN5c760852-800b-463e-8059-06a9a82c2225104
312961simvastatin 20 MG Oral TabletSCD5c760852-800b-463e-8059-06a9a82c2225104

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
71335-9642-17133596420130 TABLET, FILM COATED in 1 BOTTLE (71335-9642-1) 2023-02-27NoNoHistorical
71335-9642-27133596420260 TABLET, FILM COATED in 1 BOTTLE (71335-9642-2) 2023-02-27NoNoHistorical
71335-9642-371335964203100 TABLET, FILM COATED in 1 BOTTLE (71335-9642-3) 2025-03-03NoNoHistorical
71335-9642-47133596420490 TABLET, FILM COATED in 1 BOTTLE (71335-9642-4) 2023-02-17NoNoHistorical
71335-9642-571335964205120 TABLET, FILM COATED in 1 BOTTLE (71335-9642-5) 2025-03-12NoNoHistorical
71335-9642-671335964206180 TABLET, FILM COATED in 1 BOTTLE (71335-9642-6) 2026-04-15NoNoHistorical
71335-9642-7713359642073 TABLET, FILM COATED in 1 BOTTLE (71335-9642-7) 2026-04-15NoNoHistorical
71335-9642-87133596420810 TABLET, FILM COATED in 1 BOTTLE (71335-9642-8) 2026-04-15NoNoHistorical