FDA.reportPublic FDA data

pravastatin sodium

Product NDC
53217-203
11-digit product format
532170203
Labeler code
53217
Product ID
53217-203_bdb6766b-dc84-4322-aeca-cf7158c02e3a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
pravastatin sodium
Dosage form
TABLET
Route
ORAL
Labeler
Aidarex Pharmaceuticals LLC
Application
ANDA077751
Marketing category
ANDA
Marketing start
2010-03-30
Marketing end
0000-00-00
Substance
PRAVASTATIN SODIUM
Active strength
10 mg/1
Pharmacologic classes
HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2019-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
36361c23-a766-1581-d616-2080c781a50cProduct name520190314

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
53217-203-302020-01-31C16284748780-19d75b9cf-fe2d-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use PRAVASTATIN SODIUM TABLETS safely and effectively. See full prescribing information for PRAVASTATIN SODIUM TABLETS. PRAVASTATIN SODIUM tablets, for oral use Initial U.S. Approval: 1991
53217-203-602020-01-31C16284748780-19d75b9cf-fe2d-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use PRAVASTATIN SODIUM TABLETS safely and effectively. See full prescribing information for PRAVASTATIN SODIUM TABLETS. PRAVASTATIN SODIUM tablets, for oral use Initial U.S. Approval: 1991
53217-203-902020-01-31C16284748780-19d75b9cf-fe2d-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use PRAVASTATIN SODIUM TABLETS safely and effectively. See full prescribing information for PRAVASTATIN SODIUM TABLETS. PRAVASTATIN SODIUM tablets, for oral use Initial U.S. Approval: 1991

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53217-203-30pravastatin sodium30 in 1 BOTTLETABLET301
53217-203-60pravastatin sodium60 in 1 BOTTLETABLET601
53217-203-90pravastatin sodium90 in 1 BOTTLETABLET901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
53217-203-30EA - Each53217-203db359fb1-5b59-407c-988e-e93b8cf6fab212017-03-06
53217-203-90EA - Each53217-203bb930d5f-3614-41bb-b8e9-144ba0c078b912017-03-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53217-203PRAVASTATIN SODIUM TABLET [AIDAREX PHARMACEUTICALS LLC]1Legacy NDC, 3 package rows20170228_6024cde1-4a34-4004-8ab9-b0eb5c5625cd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
904458pravastatin sodium 10 MG Oral TabletPSN6024cde1-4a34-4004-8ab9-b0eb5c5625cd1
904458pravastatin sodium 10 MG Oral TabletSCD6024cde1-4a34-4004-8ab9-b0eb5c5625cd1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
53217-203-305321702033030 in 1 BOTTLEHistorical
53217-203-605321702036060 in 1 BOTTLEHistorical
53217-203-905321702039090 in 1 BOTTLEHistorical