Pravastatin Sodium

Product NDC
16714-570
11-digit product format
167140570
Labeler code
16714
Product ID
16714-570_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
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
Rxcui904458, 904467, 904475, 904481

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
36361c23-a766-1581-d616-2080c781a50cProduct name520190314

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
16714-570-01Pravastatin Sodium90 in 1 BOTTLETABLET903
16714-570-02Pravastatin Sodium500 in 1 BOTTLETABLET5003

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16714-570-01EA - Each16714-57070206885-f4c6-47f0-a6c0-e2d6b328f0ec12022-11-07
16714-570-02EA - Each16714-570688303af-3625-4b89-8387-a0d9ccb1882212022-11-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16714-570PRAVASTATIN 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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
16714-570-011671405700190 TABLET in 1 BOTTLE (16714-570-01) 90 tablet2022-08-120000-00-00NoNoCurrent
16714-570-0216714057002500 TABLET in 1 BOTTLE (16714-570-02) 500 tablet2022-08-120000-00-00NoNoCurrent