PRAVASTATIN SODIUM

Product NDC
71610-637
11-digit product format
716100637
Labeler code
71610
Product ID
71610-637_5d082e37-f27a-4be2-bf4c-8e1c5bb976af
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PRAVASTATIN SODIUM
Dosage form
TABLET
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
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
2026-12-31
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
71610-637-307161006373030 TABLET in 1 BOTTLE (71610-637-30) 30 tablet2022-02-24NoNoHistorical
71610-637-457161006374545 TABLET in 1 BOTTLE (71610-637-45) 45 tablet2022-02-24NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
PRAVASTATIN SODIUMAphena Pharma Solutions - Tennessee, LLC2022-03-03HUMAN PRESCRIPTION DRUG LABEL1