Pravastatin Sodium

Product NDC
16714-560
11-digit product format
167140560
Labeler code
16714
Product ID
16714-560_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
40 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
16714-560-011671405600190 TABLET in 1 BOTTLE (16714-560-01) 90 tablet2022-08-12NoNoHistorical
16714-560-0216714056002500 TABLET in 1 BOTTLE (16714-560-02) 500 tablet2022-08-12NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Pravastatin SodiumNorthStar RxLLC | Glenmark Pharmaceuticals Limited | Glenmark Pharmaceuticals Inc., USA2023-03-03HUMAN PRESCRIPTION DRUG LABEL3