PRAVASTATIN SODIUM

Product NDC
0615-8618
11-digit product format
006158618
Labeler code
0615
Product ID
0615-8618_c9527ee1-8502-4ce1-b02a-e73e80c893f8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PRAVASTATIN SODIUM
Dosage form
TABLET
Route
ORAL
Labeler
NCS HealthCare of KY, LLC dba Vangard Labs
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, 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
0615-8618-39PRAVASTATIN SODIUM30 in 1 BLISTER PACKTABLET301

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
904458pravastatin sodium 10 MG Oral TabletPSN64ccb4b5-b77e-4b23-8c74-4685287edb4b1
904467pravastatin sodium 20 MG Oral TabletPSN64ccb4b5-b77e-4b23-8c74-4685287edb4b1
904475pravastatin sodium 40 MG Oral TabletPSN64ccb4b5-b77e-4b23-8c74-4685287edb4b1
904481pravastatin sodium 80 MG Oral TabletPSN64ccb4b5-b77e-4b23-8c74-4685287edb4b1
904458pravastatin sodium 10 MG Oral TabletSCD64ccb4b5-b77e-4b23-8c74-4685287edb4b1
904467pravastatin sodium 20 MG Oral TabletSCD64ccb4b5-b77e-4b23-8c74-4685287edb4b1
904475pravastatin sodium 40 MG Oral TabletSCD64ccb4b5-b77e-4b23-8c74-4685287edb4b1
904481pravastatin sodium 80 MG Oral TabletSCD64ccb4b5-b77e-4b23-8c74-4685287edb4b1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0615-8618-390061586183930 TABLET in 1 BLISTER PACK (0615-8618-39) 30 tablet2026-02-18NoNoCurrent