FDA.reportPublic FDA data

Pravastatin Sodium

Product NDC
50090-5927
11-digit product format
500905927
Labeler code
50090
Product ID
50090-5927_5651e289-114d-4e4f-831c-c369c7148af1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pravastatin Sodium
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA077793
Marketing category
ANDA
Marketing start
2008-09-29
Marketing end
0000-00-00
Substance
PRAVASTATIN SODIUM
Active strength
80 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
36361c23-a766-1581-d616-2080c781a50cProduct name520190314

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-5927-02024-01-30C16284748780-11030e365-01fe-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
50090-5927-12024-01-30C16284748780-11030e365-01fe-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
50090-5927-0Pravastatin Sodium30 in 1 BOTTLETABLET301
50090-5927-1Pravastatin Sodium90 in 1 BOTTLETABLET901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-5927-0EA - Each50090-592792e82af7-4c3b-416b-a8b2-5a316d53790612022-06-06
50090-5927-1EA - Each50090-592723e07edc-479c-41f7-a122-7789decf5d8b12022-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-5927PRAVASTATIN SODIUM TABLET [A-S MEDICATION SOLUTIONS]1Legacy NDC, 2 package rows20220303_72f8a4bc-f921-4f28-b2f4-0f4433430885.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
904481pravastatin sodium 80 MG Oral TabletPSN72f8a4bc-f921-4f28-b2f4-0f44334308851
904481pravastatin sodium 80 MG Oral TabletSCD72f8a4bc-f921-4f28-b2f4-0f44334308851

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-5927-05009059270030 TABLET in 1 BOTTLE (50090-5927-0) 30 tablet2022-03-010000-00-00NoNoCurrent
50090-5927-15009059270190 TABLET in 1 BOTTLE (50090-5927-1) 90 tablet2022-03-010000-00-00NoNoCurrent