FDA.reportPublic FDA data

PRAVASTATIN SODIUM

Product NDC
50090-3204
11-digit product format
500903204
Labeler code
50090
Product ID
50090-3204_4ff259d6-5a83-482d-9e02-08fa0bf3ce08
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
80 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 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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-3204-02023-02-06C16284748780-1f386c64a-24b5-0266-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
50090-3204-12023-02-06C16284748780-1f386c64a-24b5-0266-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
50090-3204-02023-01-30C16284748780-1f386c64a-24b5-0266-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
50090-3204-12023-01-30C16284748780-1f386c64a-24b5-0266-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
50090-3204-0PRAVASTATIN SODIUM30 in 1 BOTTLETABLET3029
50090-3204-1PRAVASTATIN SODIUM90 in 1 BOTTLE, PLASTICTABLET9029

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-3204-0EA - Each50090-320487802e70-cdf5-44b0-ac86-9e09d69fdf3712018-12-13
50090-3204-1EA - Each50090-320477204c51-3e75-4352-86f5-a7a03d1edf4912019-05-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-3204PRAVASTATIN SODIUM TABLET [A-S MEDICATION SOLUTIONS]29Current NDC, Legacy NDC, 2 package rows20241025_7b4ef7a8-47e5-428f-91de-7307dcbb9167.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
904481pravastatin sodium 80 MG Oral TabletPSN7b4ef7a8-47e5-428f-91de-7307dcbb916729
904481pravastatin sodium 80 MG Oral TabletSCD7b4ef7a8-47e5-428f-91de-7307dcbb916729

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-3204-05009032040030 TABLET in 1 BOTTLE (50090-3204-0) 30 tablet2017-10-230000-00-00NoNoCurrent
50090-3204-15009032040190 TABLET in 1 BOTTLE, PLASTIC (50090-3204-1) 90 tablet2014-11-280000-00-00NoNoCurrent