FDA.reportPublic FDA data

Pravastatin Sodium

Product NDC
50090-5809
11-digit product format
500905809
Labeler code
50090
Product ID
50090-5809_f22b7db7-372b-4cb8-a08f-7637e0fa46e0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pravastatin Sodium
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA077987
Marketing category
ANDA
Marketing start
2007-12-28
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
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
36361c23-a766-1581-d616-2080c781a50cProduct name520190314
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-5809-02023-02-07C16284748780-1f386c64a-344a-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
50090-5809-12023-02-07C16284748780-1f386c64a-344a-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
50090-5809-02023-01-30C16284748780-1f386c64a-344a-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
50090-5809-12023-01-30C16284748780-1f386c64a-344a-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
50090-5809-0Pravastatin Sodium30 in 1 BOTTLETABLET303
50090-5809-1Pravastatin Sodium90 in 1 BOTTLETABLET903

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-5809-0EA - Each50090-5809ddc4eb01-2820-4f41-b8cb-24cb3693efe012022-07-06
50090-5809-1EA - Each50090-580939c58343-016b-4b14-98e1-85bf73e4353f12022-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-5809PRAVASTATIN SODIUM TABLET [A-S MEDICATION SOLUTIONS]3Current NDC, Legacy NDC, 2 package rows20230208_3a08fa97-24c3-4a4a-a0aa-26e50cbfc52d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
904481pravastatin sodium 80 MG Oral TabletPSN3a08fa97-24c3-4a4a-a0aa-26e50cbfc52d3
904481pravastatin sodium 80 MG Oral TabletSCD3a08fa97-24c3-4a4a-a0aa-26e50cbfc52d3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-5809-05009058090030 TABLET in 1 BOTTLE (50090-5809-0) 30 tablet2021-10-150000-00-00NoNoCurrent
50090-5809-15009058090190 TABLET in 1 BOTTLE (50090-5809-1) 90 tablet2021-10-150000-00-00NoNoCurrent