FDA.reportPublic FDA data

SIMVASTATIN

Product NDC
50090-4901
11-digit product format
500904901
Labeler code
50090
Product ID
50090-4901_9374be5c-e2e4-4d80-87f7-1464b70e2af9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
SIMVASTATIN
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA078103
Marketing category
ANDA
Marketing start
2016-02-19
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
SIMVASTATIN
Listing expiration
2027-12-31

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
43d7afbf-e4f7-4bf9-9d8f-6c620b3b3db6Product name120160615
0a5e5249-329b-0cff-e714-77159f193a87Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-4901-02023-02-07C16284748780-1f386c649-cb9b-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
50090-4901-02023-01-30C16284748780-1f386c649-cb9b-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
50090-4901-0SIMVASTATIN90 in 1 BOTTLETABLET, FILM COATED909

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-4901SIMVASTATIN TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]7Current NDC, Legacy NDC, 1 package rows20241017_d099d003-4c7c-4e35-ad6e-94ddf20035b7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198211simvastatin 40 MG Oral TabletPSNd099d003-4c7c-4e35-ad6e-94ddf20035b79
198211simvastatin 40 MG Oral TabletSCDd099d003-4c7c-4e35-ad6e-94ddf20035b79

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-4901-05009049010090 TABLET, FILM COATED in 1 BOTTLE (50090-4901-0) 2020-02-170000-00-00NoNoCurrent