FDA.reportPublic FDA data

PRAVASTATIN SODIUM

Product NDC
50090-6145
11-digit product format
500906145
Labeler code
50090
Product ID
50090-6145_5ae18dbc-c969-4751-9700-764eb2c58603
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PRAVASTATIN SODIUM
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA207068
Marketing category
ANDA
Marketing start
2017-02-16
Marketing end
0000-00-00
Substance
PRAVASTATIN SODIUM
Active strength
40 mg/1
Pharmacologic classes
HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
36361c23-a766-1581-d616-2080c781a50cProduct name520190314
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-6145-02024-01-30C16284748780-11030e365-336f-111a-e063-dadaa90a10e2These 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
50090-6145-12024-01-30C16284748780-11030e365-336f-111a-e063-dadaa90a10e2These 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
50090-6145-0PRAVASTATIN SODIUM30 in 1 BOTTLETABLET306
50090-6145-1PRAVASTATIN SODIUM90 in 1 BOTTLETABLET906

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-6145-0EA - Each50090-6145b5eb1e84-b92c-4f2b-b874-e9eb5d13b12212022-11-07
50090-6145-1EA - Each50090-614562396618-d90b-402a-b8c4-41327667da7c12022-11-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-6145PRAVASTATIN SODIUM TABLET [A-S MEDICATION SOLUTIONS]6Legacy NDC, 2 package rows20221008_833f3b8a-ec0d-4576-868a-d1412c9b300d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
904475pravastatin sodium 40 MG Oral TabletPSN833f3b8a-ec0d-4576-868a-d1412c9b300d6
904475pravastatin sodium 40 MG Oral TabletSCD833f3b8a-ec0d-4576-868a-d1412c9b300d6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-6145-05009061450030 TABLET in 1 BOTTLE (50090-6145-0) 30 tablet2022-10-040000-00-00NoNoCurrent
50090-6145-15009061450190 TABLET in 1 BOTTLE (50090-6145-1) 90 tablet2022-10-040000-00-00NoNoCurrent