FDA.reportPublic FDA data

PRAVASTATIN SODIUM

Product NDC
71335-1243
11-digit product format
713351243
Labeler code
71335
Product ID
71335-1243_bfb6cf43-415c-42f1-8cc6-ac4f1eff0dca
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
10 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
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PRAVASTATIN SODIUM10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii3M8608UQ61
Rxcui904458

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
71335-1243-1PRAVASTATIN SODIUM30 in 1 BOTTLETABLET30107
71335-1243-2PRAVASTATIN SODIUM90 in 1 BOTTLETABLET90107
71335-1243-3PRAVASTATIN SODIUM10 in 1 BOTTLETABLET10107

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-1243-1EA - Each71335-124379de7917-2c3b-4a40-b538-489fa7389ff012020-09-14
71335-1243-2EA - Each71335-12437b6a5a82-2a28-4353-ad5d-6229450371cb12020-09-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1243PRAVASTATIN SODIUM TABLET [BRYANT RANCH PREPACK]107Current NDC, Legacy NDC, 3 package rows20250224_7b900a28-f20e-49d5-98a9-5513fee0a901.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
904458pravastatin sodium 10 MG Oral TabletPSN7b900a28-f20e-49d5-98a9-5513fee0a901107
904458pravastatin sodium 10 MG Oral TabletSCD7b900a28-f20e-49d5-98a9-5513fee0a901107

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-1243-17133512430130 TABLET in 1 BOTTLE (71335-1243-1) 30 tablet2019-11-050000-00-00NoNoCurrent
71335-1243-27133512430290 TABLET in 1 BOTTLE (71335-1243-2) 90 tablet2019-06-100000-00-00NoNoCurrent
71335-1243-37133512430310 TABLET in 1 BOTTLE (71335-1243-3) 10 tablet2025-01-300000-00-00NoNoCurrent