Pravastatin Sodium

Product NDC
35356-919
11-digit product format
353560919
Labeler code
35356
Product ID
35356-919_77f23591-e677-43b5-8ed8-47059fc8ed3f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
pravastatin sodium
Dosage form
TABLET
Route
ORAL
Labeler
Lake Erie Medical DBA Quality Care Products LLC
Application
ANDA076341
Marketing category
ANDA
Marketing start
2011-07-18
Marketing end
2028-04-30
Substance
PRAVASTATIN SODIUM
Active strength
20 mg/1
Pharmacologic classes
HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]
NDC exclude flag
No
Current FDA listing
Yes

Related Records

Related UNII Ingredients

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

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
35356-919-303535609193030 TABLET in 1 BOTTLE (35356-919-30) 30 tablet2011-07-182028-04-30NoNoHistorical
35356-919-903535609199090 TABLET in 1 BOTTLE (35356-919-90) 90 tablet2011-07-182028-04-30NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Pravastatin Sodium Tablets, USP 10 mg, 20 mg, 40 mg and 80 mgLake Erie Medical DBA Quality Care Products LLC2024-12-11HUMAN PRESCRIPTION DRUG LABEL9