FDA.reportPublic FDA data

PRAVASTATIN SODIUM

Product NDC
71335-0947
11-digit product format
713350947
Labeler code
71335
Product ID
71335-0947_eaf669a7-a5e3-4241-aed5-f696283508e6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PRAVASTATIN SODIUM
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA077917
Marketing category
ANDA
Marketing start
2008-07-24
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
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PRAVASTATIN SODIUM20 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii3M8608UQ61
Rxcui904467

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
36361c23-a766-1581-d616-2080c781a50cProduct name520190314
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71335-0947-12024-05-21C16284748780-11030e365-62b2-111a-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
71335-0947-22024-05-21C16284748780-11030e365-62b2-111a-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
71335-0947-32024-05-21C16284748780-11030e365-62b2-111a-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
71335-0947-42024-05-21C16284748780-11030e365-62b2-111a-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
71335-0947-52024-05-21C16284748780-11030e365-62b2-111a-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
71335-0947-12024-01-30C16284748780-11030e365-62b2-111a-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
71335-0947-22024-01-30C16284748780-11030e365-62b2-111a-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
71335-0947-32024-01-30C16284748780-11030e365-62b2-111a-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
71335-0947-42024-01-30C16284748780-11030e365-62b2-111a-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
71335-0947-52024-01-30C16284748780-11030e365-62b2-111a-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
71335-0947-1PRAVASTATIN SODIUM30 in 1 BOTTLETABLET307
71335-0947-2PRAVASTATIN SODIUM90 in 1 BOTTLETABLET907
71335-0947-3PRAVASTATIN SODIUM100 in 1 BOTTLETABLET1007
71335-0947-4PRAVASTATIN SODIUM60 in 1 BOTTLETABLET607
71335-0947-5PRAVASTATIN SODIUM10 in 1 BOTTLETABLET107

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-0947PRAVASTATIN SODIUM TABLET [BRYANT RANCH PREPACK]7Current NDC, Legacy NDC, 5 package rows20240522_24471777-5cd6-4c46-a5f2-a349fadc830e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
904467pravastatin sodium 20 MG Oral TabletPSN24471777-5cd6-4c46-a5f2-a349fadc830e7
904467pravastatin sodium 20 MG Oral TabletSCD24471777-5cd6-4c46-a5f2-a349fadc830e7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-0947-17133509470130 TABLET in 1 BOTTLE (71335-0947-1) 30 tablet2022-09-230000-00-00NoNoCurrent
71335-0947-27133509470290 TABLET in 1 BOTTLE (71335-0947-2) 90 tablet2018-09-040000-00-00NoNoCurrent
71335-0947-371335094703100 TABLET in 1 BOTTLE (71335-0947-3) 100 tablet2022-09-230000-00-00NoNoCurrent
71335-0947-47133509470460 TABLET in 1 BOTTLE (71335-0947-4) 60 tablet2022-09-230000-00-00NoNoCurrent
71335-0947-57133509470510 TABLET in 1 BOTTLE (71335-0947-5) 10 tablet2022-09-230000-00-00NoNoCurrent