PRAVASTATIN SODIUM

Product NDC
0615-8621
11-digit product format
006158621
Labeler code
0615
Product ID
0615-8621_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
80 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

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
3M8608UQ61PRAVASTATIN SODIUM81131-70-6PRAVASTATIN SODIUM

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0615-8621-390061586213930 TABLET in 1 BLISTER PACK (0615-8621-39) 30 tablet2026-02-11NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
PRAVASTATIN SODIUMNCS HealthCare of KY, LLC dba Vangard Labs | Apotex Inc.2026-02-27HUMAN PRESCRIPTION DRUG LABEL1