FDA.reportPublic FDA data

Simvastatin

Product NDC
50090-3922
11-digit product format
500903922
Labeler code
50090
Product ID
50090-3922_db5961ba-dcf6-4d53-b1da-330a9a588b6a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Simvastatin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA200895
Marketing category
ANDA
Marketing start
2014-12-09
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
2020-12-31
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#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-3922-02023-01-30C16284748780-1f386c64a-24ab-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use SIMVASTATIN TABLETS safely and effectively. See full prescribing information for SIMVASTATIN TABLETS. SIMVASTATIN tablets, for oral use Initial U.S. Approval: 1991
50090-3922-12023-01-30C16284748780-1f386c64a-24ab-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use SIMVASTATIN TABLETS safely and effectively. See full prescribing information for SIMVASTATIN TABLETS. SIMVASTATIN tablets, for oral use Initial U.S. Approval: 1991

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-3922-0Simvastatin30 in 1 BOTTLETABLET, FILM COATED303
50090-3922-1Simvastatin90 in 1 BOTTLE, PLASTICTABLET, FILM COATED903

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-3922SIMVASTATIN TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]3Legacy NDC, 2 package rows20190501_7a8d554b-5f4c-4e4d-a417-9502f114475b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
200345simvastatin 80 MG Oral TabletPSN7a8d554b-5f4c-4e4d-a417-9502f114475b3
200345simvastatin 80 MG Oral TabletSCD7a8d554b-5f4c-4e4d-a417-9502f114475b3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-3922-05009039220030 TABLET, FILM COATED in 1 BOTTLE (50090-3922-0) 2018-12-060000-00-00NoNoCurrent
50090-3922-15009039220190 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50090-3922-1) 2014-12-090000-00-00NoNoCurrent