FDA.reportPublic FDA data

Simvastatin

Product NDC
71335-2262
11-digit product format
713352262
Labeler code
71335
Product ID
71335-2262_9c20e921-98cb-49ca-9d7a-0877c9f2c73a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Simvastatin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA077691
Marketing category
ANDA
Marketing start
2006-12-20
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
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
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
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
71335-2262-1Simvastatin30 in 1 BOTTLETABLET, FILM COATED30101
71335-2262-2Simvastatin90 in 1 BOTTLETABLET, FILM COATED90101
71335-2262-3Simvastatin60 in 1 BOTTLETABLET, FILM COATED60101
71335-2262-4Simvastatin10 in 1 BOTTLETABLET, FILM COATED10101

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-2262SIMVASTATIN TABLET, FILM COATED [BRYANT RANCH PREPACK]101Current NDC, 4 package rows20240420_a3bfe314-1fe4-4d2a-aecb-4194f3bd8f22.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312962simvastatin 5 MG Oral TabletPSNa3bfe314-1fe4-4d2a-aecb-4194f3bd8f22101
312962simvastatin 5 MG Oral TabletSCDa3bfe314-1fe4-4d2a-aecb-4194f3bd8f22101

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
71335-2262-17133522620130 TABLET, FILM COATED in 1 BOTTLE (71335-2262-1) 2024-04-03NoNoHistorical
71335-2262-27133522620290 TABLET, FILM COATED in 1 BOTTLE (71335-2262-2) 2023-10-10NoNoHistorical
71335-2262-37133522620360 TABLET, FILM COATED in 1 BOTTLE (71335-2262-3) 2024-04-03NoNoHistorical
71335-2262-47133522620410 TABLET, FILM COATED in 1 BOTTLE (71335-2262-4) 2024-04-03NoNoHistorical