FDA.reportPublic FDA data

PRAVASTATIN SODIUM

Product NDC
71335-2253
11-digit product format
713352253
Labeler code
71335
Product ID
71335-2253_198579ff-220c-4491-8968-73f695a82b09
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
80 mg/1
Pharmacologic classes
HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
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 SODIUM80 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii3M8608UQ61
Rxcui904481

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
71335-2253-1PRAVASTATIN SODIUM30 in 1 BOTTLETABLET30104
71335-2253-2PRAVASTATIN SODIUM90 in 1 BOTTLETABLET90104
71335-2253-3PRAVASTATIN SODIUM58 in 1 BOTTLETABLET58104
71335-2253-4PRAVASTATIN SODIUM88 in 1 BOTTLETABLET88104
71335-2253-5PRAVASTATIN SODIUM10 in 1 BOTTLETABLET10104

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-2253PRAVASTATIN SODIUM TABLET [BRYANT RANCH PREPACK]103Current NDC, 5 package rows20250228_c0b1b483-1a19-4966-89b1-118ec660f203.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
904481pravastatin sodium 80 MG Oral TabletPSNc0b1b483-1a19-4966-89b1-118ec660f203104
904481pravastatin sodium 80 MG Oral TabletSCDc0b1b483-1a19-4966-89b1-118ec660f203104

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71335-2253-17133522530130 TABLET in 1 BOTTLE (71335-2253-1) 30 tablet2025-01-31NoNoHistorical
71335-2253-27133522530290 TABLET in 1 BOTTLE (71335-2253-2) 90 tablet2025-01-31NoNoHistorical
71335-2253-37133522530358 TABLET in 1 BOTTLE (71335-2253-3) 58 tablet2025-01-31NoNoHistorical
71335-2253-47133522530488 TABLET in 1 BOTTLE (71335-2253-4) 88 tablet2025-01-31NoNoHistorical
71335-2253-57133522530510 TABLET in 1 BOTTLE (71335-2253-5) 10 tablet2025-01-31NoNoHistorical