FDA.reportPublic FDA data

PRAVASTATIN SODIUM

Product NDC
50090-3853
11-digit product format
500903853
Labeler code
50090
Product ID
50090-3853_10559b70-d5be-41e8-a456-cbaa4753b604
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PRAVASTATIN SODIUM
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
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
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 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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-3853-02023-02-07C16284748780-1f386c64a-28b2-0266-e053-dadaa90a7c1aThese 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
50090-3853-12023-02-07C16284748780-1f386c64a-28b2-0266-e053-dadaa90a7c1aThese 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
50090-3853-02023-01-30C16284748780-1f386c64a-28b2-0266-e053-dadaa90a7c1aThese 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
50090-3853-12023-01-30C16284748780-1f386c64a-28b2-0266-e053-dadaa90a7c1aThese 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
50090-3853-0PRAVASTATIN SODIUM90 in 1 BOTTLETABLET9011
50090-3853-1PRAVASTATIN SODIUM30 in 1 BOTTLETABLET3011

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-3853-0EA - Each50090-385301f682fc-d2db-4b8d-9474-7c5ddf3c5ac012021-10-08
50090-3853-1EA - Each50090-3853169b6ad4-8c7c-44ef-b834-aea17328c56212021-10-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-3853PRAVASTATIN SODIUM TABLET [A-S MEDICATION SOLUTIONS]9Current NDC, Legacy NDC, 2 package rows20230511_3e6d1c1e-d5f7-42ec-bcdd-8fc310acdf21.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
904458pravastatin sodium 10 MG Oral TabletPSN3e6d1c1e-d5f7-42ec-bcdd-8fc310acdf2111
904458pravastatin sodium 10 MG Oral TabletSCD3e6d1c1e-d5f7-42ec-bcdd-8fc310acdf2111

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-3853-05009038530090 TABLET in 1 BOTTLE (50090-3853-0) 90 tablet2018-11-210000-00-00NoNoCurrent
50090-3853-15009038530130 TABLET in 1 BOTTLE (50090-3853-1) 30 tablet2018-11-210000-00-00NoNoCurrent