FDA.reportPublic FDA data

simvastatin

Product NDC
43353-664
11-digit product format
433530664
Labeler code
43353
Product ID
43353-664_df1bcbaf-189a-42b4-89ec-121e42efd1a1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
simvastatin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA078155
Marketing category
ANDA
Marketing start
2008-02-26
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
43353-664-152023-01-30C16284748780-1f386c64a-2b8d-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 USP for oral use Initial U.S. Approval: 1991
43353-664-302023-01-30C16284748780-1f386c64a-2b8d-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 USP for oral use Initial U.S. Approval: 1991
43353-664-452023-01-30C16284748780-1f386c64a-2b8d-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 USP for oral use Initial U.S. Approval: 1991
43353-664-602023-01-30C16284748780-1f386c64a-2b8d-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 USP for oral use Initial U.S. Approval: 1991

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43353-664-15simvastatin15 in 1 BOTTLETABLET, FILM COATED152
43353-664-30simvastatin30 in 1 BOTTLETABLET, FILM COATED302
43353-664-45simvastatin45 in 1 BOTTLETABLET, FILM COATED452
43353-664-60simvastatin90 in 1 BOTTLETABLET, FILM COATED902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43353-664-15EA - Each43353-6647e868d69-a1b8-4b7a-a60f-239a2d2c4a1612018-07-03
43353-664-30EA - Each43353-6647c81e1f2-1ce9-4f5b-86ca-9ebb40d5eb7d12018-07-03
43353-664-45EA - Each43353-664336ce5b4-ae96-489f-991e-e9592e02709612018-07-03
43353-664-60EA - Each43353-664ee9c5db3-ddeb-4f3d-9af3-babd5534af4912018-07-03

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43353-664SIMVASTATIN TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2Legacy NDC, 4 package rows20191220_8a6972f4-f3d2-4024-93e9-bbed43784284.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
200345simvastatin 80 MG Oral TabletPSN8a6972f4-f3d2-4024-93e9-bbed437842842
200345simvastatin 80 MG Oral TabletSCD8a6972f4-f3d2-4024-93e9-bbed437842842

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
43353-664-154335306641515 TABLET, FILM COATED in 1 BOTTLE (43353-664-15) 2010-10-150000-00-00NoNoCurrent
43353-664-304335306643030 TABLET, FILM COATED in 1 BOTTLE (43353-664-30) 2010-10-150000-00-00NoNoCurrent
43353-664-454335306644545 TABLET, FILM COATED in 1 BOTTLE (43353-664-45) 2010-10-150000-00-00NoNoCurrent
43353-664-604335306646090 TABLET, FILM COATED in 1 BOTTLE (43353-664-60) 2010-10-150000-00-00NoNoCurrent