FDA.reportPublic FDA data

Simvastatin

Product NDC
50090-6424
11-digit product format
500906424
Labeler code
50090
Product ID
50090-6424_4424c77a-a34d-40d5-a79e-64ed4594e87d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Simvastatin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA077691
Marketing category
ANDA
Marketing start
2006-12-20
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
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
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
50090-6424-1Simvastatin30 in 1 BOTTLETABLET, FILM COATED303
50090-6424-2Simvastatin100 in 1 BOTTLETABLET, FILM COATED1003
50090-6424-3Simvastatin90 in 1 BOTTLETABLET, FILM COATED903
50090-6424-4Simvastatin200 in 1 BOTTLETABLET, FILM COATED2003

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-6424SIMVASTATIN TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]1Current NDC, 4 package rows20230414_7cbf645d-b1d3-413d-a4c3-c1818ed6dfd1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198211simvastatin 40 MG Oral TabletPSN7cbf645d-b1d3-413d-a4c3-c1818ed6dfd13
198211simvastatin 40 MG Oral TabletSCD7cbf645d-b1d3-413d-a4c3-c1818ed6dfd13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
50090-6424-15009064240130 TABLET, FILM COATED in 1 BOTTLE (50090-6424-1) 2023-04-06NoNoCurrent
50090-6424-250090642402100 TABLET, FILM COATED in 1 BOTTLE (50090-6424-2) 2023-04-06NoNoCurrent
50090-6424-35009064240390 TABLET, FILM COATED in 1 BOTTLE (50090-6424-3) 2023-04-06NoNoCurrent
50090-6424-450090642404200 TABLET, FILM COATED in 1 BOTTLE (50090-6424-4) 2023-04-06NoNoCurrent