Pravastatin Sodium

Product NDC
16714-559
11-digit product format
167140559
Labeler code
16714
Product ID
16714-559_fa078b35-ee9d-4b9f-bb8d-e77949c09f88
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pravastatin Sodium
Dosage form
TABLET
Route
ORAL
Labeler
NorthStar RxLLC
Application
ANDA077987
Marketing category
ANDA
Marketing start
2022-08-12
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
16714-559-011671405590190 TABLET in 1 BOTTLE (16714-559-01) 90 tablet2022-08-12NoNoHistorical
16714-559-0216714055902500 TABLET in 1 BOTTLE (16714-559-02) 500 tablet2022-08-12NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Pravastatin SodiumA-S Medication Solutions2025-05-28HUMAN PRESCRIPTION DRUG LABEL1
Pravastatin SodiumA-S Medication Solutions2025-05-28HUMAN PRESCRIPTION DRUG LABEL1
Pravastatin SodiumNorthStar RxLLC | Glenmark Pharmaceuticals Limited | Glenmark Pharmaceuticals Inc., USA2023-03-03HUMAN PRESCRIPTION DRUG LABEL3