FDA.reportPublic FDA data

Pravastatin Sodium

Product NDC
16714-559
11-digit product format
167140559
Labeler code
16714
Product ID
16714-559_fa078b35-ee9d-4b9f-bb8d-e77949c09f88
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pravastatin Sodium
Dosage form
TABLET
Route
ORAL
Labeler
NorthStar RxLLC
Application
ANDA077987
Marketing category
ANDA
Marketing start
2022-08-12
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
Rxcui904458, 904467, 904475, 904481

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
16714-559-01Pravastatin Sodium90 in 1 BOTTLETABLET903
16714-559-02Pravastatin Sodium500 in 1 BOTTLETABLET5003

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16714-559-01EA - Each16714-559b3e9f1c3-0f00-49e0-b252-c68009508f0e12022-11-07
16714-559-02EA - Each16714-559c430a10b-9a45-45ba-be11-0459b34dbc3212022-11-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16714-559PRAVASTATIN SODIUM TABLET [NORTHSTAR RXLLC]3Current NDC, Legacy NDC, 2 package rows20230306_ce15ad07-3286-478f-9f30-1db6a45ed402.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
904458pravastatin sodium 10 MG Oral TabletPSNce15ad07-3286-478f-9f30-1db6a45ed4023
904467pravastatin sodium 20 MG Oral TabletPSNce15ad07-3286-478f-9f30-1db6a45ed4023
904475pravastatin sodium 40 MG Oral TabletPSNce15ad07-3286-478f-9f30-1db6a45ed4023
904481pravastatin sodium 80 MG Oral TabletPSNce15ad07-3286-478f-9f30-1db6a45ed4023
904458pravastatin sodium 10 MG Oral TabletSCDce15ad07-3286-478f-9f30-1db6a45ed4023
904467pravastatin sodium 20 MG Oral TabletSCDce15ad07-3286-478f-9f30-1db6a45ed4023
904475pravastatin sodium 40 MG Oral TabletSCDce15ad07-3286-478f-9f30-1db6a45ed4023
904481pravastatin sodium 80 MG Oral TabletSCDce15ad07-3286-478f-9f30-1db6a45ed4023
904467pravastatin sodium 20 MG Oral TabletPSN4015f184-b57e-4d32-9cef-15c6e1cefe241
904467pravastatin sodium 20 MG Oral TabletPSNb7a84cc1-f6e4-40be-9e68-cf7d43bbd6171
904467pravastatin sodium 20 MG Oral TabletSCD4015f184-b57e-4d32-9cef-15c6e1cefe241
904467pravastatin sodium 20 MG Oral TabletSCDb7a84cc1-f6e4-40be-9e68-cf7d43bbd6171

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
16714-559-011671405590190 TABLET in 1 BOTTLE (16714-559-01) 90 tablet2022-08-120000-00-00NoNoCurrent
16714-559-0216714055902500 TABLET in 1 BOTTLE (16714-559-02) 500 tablet2022-08-120000-00-00NoNoCurrent