Pravastatin Sodium

Product NDC
53808-0398
11-digit product format
538080398
Labeler code
53808
Product ID
53808-0398_9db1257e-0491-4c8d-85d6-37fa1f425cbd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pravastatin Sodium
Dosage form
TABLET
Route
ORAL
Labeler
State of Florida DOH Central Pharmacy
Application
ANDA077987
Marketing category
ANDA
Marketing start
2009-07-01
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
E
Listing certified through
2017-12-31
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
53808-0398-12021-01-29C16284748780-1956f9ecf-dcaa-621f-e053-dbdaa90a74adPravastatin Sodium Tablets
53808-0398-12019-10-21C16284748780-1956f9ecf-dcaa-621f-e053-dbdaa90a74adPravastatin Sodium Tablets

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53808-0398-1Pravastatin Sodium30 in 1 BLISTER PACKTABLET301

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53808-0398PRAVASTATIN SODIUM TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1Legacy NDC, 1 package rows20100614_ea2d1275-8437-4979-8199-24eb9678be94.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
904458pravastatin sodium 10 MG Oral TabletPSNea2d1275-8437-4979-8199-24eb9678be941
904481pravastatin sodium 80 MG Oral TabletPSNea2d1275-8437-4979-8199-24eb9678be941
904458pravastatin sodium 10 MG Oral TabletSCDea2d1275-8437-4979-8199-24eb9678be941
904481pravastatin sodium 80 MG Oral TabletSCDea2d1275-8437-4979-8199-24eb9678be941

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
53808-0398-15380803980130 in 1 BLISTER PACKHistorical