FDA.reportPublic FDA data

PRAVASTATIN SODIUM

Product NDC
71335-1022
11-digit product format
713351022
Labeler code
71335
Product ID
71335-1022_98f93c24-e690-4803-b446-17b44f8f25f8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PRAVASTATIN SODIUM
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA076341
Marketing category
ANDA
Marketing start
2011-07-18
Substance
PRAVASTATIN SODIUM
Active strength
20 mg/1
Pharmacologic classes
HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
PRAVASTATIN SODIUM
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PRAVASTATIN SODIUM20 mg/1

DailyMed Product Concepts#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-1022-1PRAVASTATIN SODIUM30 in 1 BOTTLETABLET30104
71335-1022-2PRAVASTATIN SODIUM90 in 1 BOTTLETABLET90104
71335-1022-3PRAVASTATIN SODIUM100 in 1 BOTTLETABLET100104
71335-1022-4PRAVASTATIN SODIUM60 in 1 BOTTLETABLET60104
71335-1022-5PRAVASTATIN SODIUM10 in 1 BOTTLETABLET10104

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1022PRAVASTATIN SODIUM TABLET [BRYANT RANCH PREPACK]104Current NDC, Legacy NDC, 5 package rows20250223_8d1bf7a5-bf11-47e3-afca-dcc13f2d3068.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
904467pravastatin sodium 20 MG Oral TabletPSN8d1bf7a5-bf11-47e3-afca-dcc13f2d3068104
904467pravastatin sodium 20 MG Oral TabletSCD8d1bf7a5-bf11-47e3-afca-dcc13f2d3068104

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-1022-17133510220130 TABLET in 1 BOTTLE (71335-1022-1) 30 tablet2019-01-140000-00-00NoNoCurrent
71335-1022-27133510220290 TABLET in 1 BOTTLE (71335-1022-2) 90 tablet2018-12-070000-00-00NoNoCurrent
71335-1022-371335102203100 TABLET in 1 BOTTLE (71335-1022-3) 100 tablet2025-01-290000-00-00NoNoCurrent
71335-1022-47133510220460 TABLET in 1 BOTTLE (71335-1022-4) 60 tablet2025-01-290000-00-00NoNoCurrent
71335-1022-57133510220510 TABLET in 1 BOTTLE (71335-1022-5) 10 tablet2025-01-290000-00-00NoNoCurrent