FDA.reportPublic FDA data

Simvastatin

Product NDC
50090-4801
11-digit product format
500904801
Labeler code
50090
Product ID
50090-4801_be40524b-20df-4ee3-b575-1c104364bdcb
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
20 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
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-4801-12023-08-31C16284748780-1f386c649-af46-0266-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
50090-4801-22023-08-31C16284748780-1f386c649-af46-0266-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
50090-4801-12023-01-30C16284748780-1f386c649-af46-0266-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
50090-4801-22023-01-30C16284748780-1f386c649-af46-0266-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
50090-4801-0Simvastatin1000 in 1 BOTTLETABLET, FILM COATED100012
50090-4801-1Simvastatin30 in 1 BOTTLETABLET, FILM COATED3012
50090-4801-2Simvastatin90 in 1 BOTTLETABLET, FILM COATED9012
50090-4801-3Simvastatin200 in 1 BOTTLETABLET, FILM COATED20012

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-4801SIMVASTATIN TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]12Current NDC, Legacy NDC, 4 package rows20250426_9133520e-1ffd-4ef1-bced-6b0c9a579f39.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312961simvastatin 20 MG Oral TabletPSN9133520e-1ffd-4ef1-bced-6b0c9a579f3912
312961simvastatin 20 MG Oral TabletSCD9133520e-1ffd-4ef1-bced-6b0c9a579f3912

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-4801-0500904801001000 TABLET, FILM COATED in 1 BOTTLE (50090-4801-0) 2023-08-28NoNoCurrent
50090-4801-15009048010130 TABLET, FILM COATED in 1 BOTTLE (50090-4801-1) 2019-12-260000-00-00NoNoCurrent
50090-4801-25009048010290 TABLET, FILM COATED in 1 BOTTLE (50090-4801-2) 2019-12-200000-00-00NoNoCurrent
50090-4801-350090480103200 TABLET, FILM COATED in 1 BOTTLE (50090-4801-3) 2023-09-06NoNoCurrent