Pravastatin sodium

Product NDC
68788-4049
11-digit product format
687884049
Labeler code
68788
Product ID
68788-4049_e6a3d99c-c9cc-49d9-b0f9-503770307b70
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pravastatin sodium
Dosage form
TABLET
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA076056
Marketing category
ANDA
Marketing start
2025-10-31
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
68788-4049-36878840490330 TABLET in 1 BOTTLE (68788-4049-3) 30 tablet2025-10-31NoNoHistorical
68788-4049-66878840490660 TABLET in 1 BOTTLE (68788-4049-6) 60 tablet2025-10-31NoNoHistorical
68788-4049-96878840490990 TABLET in 1 BOTTLE (68788-4049-9) 90 tablet2025-10-31NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Pravastatin sodiumPreferred Pharmaceuticals Inc.2025-10-31HUMAN PRESCRIPTION DRUG LABEL1