Simvastatin

Product NDC
50090-3473
11-digit product format
500903473
Labeler code
50090
Product ID
50090-3473_b1ef9a7b-0eac-4ed0-8199-7eec873b9f84
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
Marketing end
0000-00-00
Substance
SIMVASTATIN
Active strength
80 mg/1
Pharmacologic classes
HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

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

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-3473-1Simvastatin90 in 1 BOTTLETABLET, FILM COATED903

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-3473SIMVASTATIN TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]3Legacy NDC, 1 package rows20200122_a9b18c3c-9a3d-442a-be96-9c36c45b3558.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
200345simvastatin 80 MG Oral TabletPSNa9b18c3c-9a3d-442a-be96-9c36c45b35583
200345simvastatin 80 MG Oral TabletSCDa9b18c3c-9a3d-442a-be96-9c36c45b35583

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-3473-15009034730190 TABLET, FILM COATED in 1 BOTTLE (50090-3473-1) 2018-06-130000-00-00NoNoCurrent