Pravastatin Sodium

Product NDC
68788-8871
11-digit product format
687888871
Labeler code
68788
Product ID
68788-8871_7abc1825-182d-40bc-9f7f-968e197b4246
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pravastatin Sodium
Dosage form
TABLET
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA076056
Marketing category
ANDA
Marketing start
2025-04-30
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

Related Records

Related UNII Ingredients

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

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68788-8871-36878888710330 TABLET in 1 BOTTLE (68788-8871-3) 30 tablet2025-04-30NoNoHistorical
68788-8871-66878888710660 TABLET in 1 BOTTLE (68788-8871-6) 60 tablet2025-04-30NoNoHistorical
68788-8871-96878888710990 TABLET in 1 BOTTLE (68788-8871-9) 90 tablet2025-04-30NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Pravastatin SodiumPreferred Pharmaceuticals Inc.2025-04-30HUMAN PRESCRIPTION DRUG LABEL1