FDA.reportPublic FDA data

Simvastatin

Product NDC
24658-503
11-digit product format
246580503
Labeler code
24658
Product ID
24658-503_308c04fb-d7de-2e5d-33e0-0b933531ae6c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Simvastatin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
PuraCap Laboratories, LLC
Application
ANDA078034
Marketing category
ANDA
Marketing start
2015-12-17
Marketing end
0000-00-00
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
2022-12-31
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
24658-503-102025-07-29C16284748780-13b156c62-2ab3-fb37-e063-e6dba90a4e07These 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
24658-503-302025-07-29C16284748780-13b156c62-2ab3-fb37-e063-e6dba90a4e07These 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
24658-503-452025-07-29C16284748780-13b156c62-2ab3-fb37-e063-e6dba90a4e07These 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
24658-503-902025-07-29C16284748780-13b156c62-2ab3-fb37-e063-e6dba90a4e07These 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
24658-503-10Simvastatin1000 in 1 BOTTLETABLET, FILM COATED10003
24658-503-30Simvastatin30 in 1 BOTTLETABLET, FILM COATED303
24658-503-45Simvastatin45 in 1 BOTTLETABLET, FILM COATED453
24658-503-90Simvastatin90 in 1 BOTTLETABLET, FILM COATED903

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
24658-503-10EA - Each24658-503b02cf175-0289-4a88-b121-0c3fe0d83fbb12021-01-08
24658-503-30EA - Each24658-503ce9d25b0-a627-4a02-9600-ed57ddb13fb612021-03-02
24658-503-45EA - Each24658-503c991ed36-da17-460a-8e90-fc3cc52ea6ee12021-03-02
24658-503-90EA - Each24658-50330a6dfa4-8153-4012-99aa-a98e7c5d432012021-03-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
24658-503SIMVASTATIN TABLET, FILM COATED [PURACAP LABORATORIES, LLC]3Legacy NDC, 4 package rows20210424_aecec1e2-93e5-f93c-84fe-dab201fe8a06.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314231simvastatin 10 MG Oral TabletPSNaecec1e2-93e5-f93c-84fe-dab201fe8a063
312961simvastatin 20 MG Oral TabletPSNaecec1e2-93e5-f93c-84fe-dab201fe8a063
198211simvastatin 40 MG Oral TabletPSNaecec1e2-93e5-f93c-84fe-dab201fe8a063
312962simvastatin 5 MG Oral TabletPSNaecec1e2-93e5-f93c-84fe-dab201fe8a063
200345simvastatin 80 MG Oral TabletPSNaecec1e2-93e5-f93c-84fe-dab201fe8a063
314231simvastatin 10 MG Oral TabletSCDaecec1e2-93e5-f93c-84fe-dab201fe8a063
312961simvastatin 20 MG Oral TabletSCDaecec1e2-93e5-f93c-84fe-dab201fe8a063
198211simvastatin 40 MG Oral TabletSCDaecec1e2-93e5-f93c-84fe-dab201fe8a063
312962simvastatin 5 MG Oral TabletSCDaecec1e2-93e5-f93c-84fe-dab201fe8a063
200345simvastatin 80 MG Oral TabletSCDaecec1e2-93e5-f93c-84fe-dab201fe8a063
312961simvastatin 20 MG Oral TabletPSNc0a303c5-6277-47ce-bb8a-bd5400fd82612
198211simvastatin 40 MG Oral TabletPSNc0a303c5-6277-47ce-bb8a-bd5400fd82612
200345simvastatin 80 MG Oral TabletPSNc0a303c5-6277-47ce-bb8a-bd5400fd82612
312961simvastatin 20 MG Oral TabletSCDc0a303c5-6277-47ce-bb8a-bd5400fd82612
198211simvastatin 40 MG Oral TabletSCDc0a303c5-6277-47ce-bb8a-bd5400fd82612
200345simvastatin 80 MG Oral TabletSCDc0a303c5-6277-47ce-bb8a-bd5400fd82612

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
24658-503-10246580503101000 TABLET, FILM COATED in 1 BOTTLE (24658-503-10) 2020-12-180000-00-00NoNoCurrent
24658-503-302465805033030 TABLET, FILM COATED in 1 BOTTLE (24658-503-30) 2020-12-180000-00-00NoNoCurrent
24658-503-452465805034545 TABLET, FILM COATED in 1 BOTTLE (24658-503-45) 2020-12-180000-00-00NoNoCurrent
24658-503-902465805039090 TABLET, FILM COATED in 1 BOTTLE (24658-503-90) 2020-12-180000-00-00NoNoCurrent