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

Additional Listing Data#

Finished product
Yes
Brand name base
Pravastatin Sodium

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PRAVASTATIN SODIUM20 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii3M8608UQ61
Rxcui904458, 904467, 904475

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
36361c23-a766-1581-d616-2080c781a50cProduct name520190314

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
35356-919-30Pravastatin Sodium30 in 1 BOTTLETABLET309
35356-919-60Pravastatin Sodium60 in 1 BOTTLETABLET609
35356-919-90Pravastatin Sodium90 in 1 BOTTLETABLET909

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
35356-919-30EA - Each35356-91923719b5f-a5ad-4628-991a-d174aa04ed6012015-10-02
35356-919-90EA - Each35356-919b72460c3-4745-498a-b991-1424c79c681912015-11-12

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
35356-919PRAVASTATIN SODIUM TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]9Current NDC, Legacy NDC, 3 package rows20241213_e7194af1-6304-4e3e-88ab-0825706a3962.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
904458pravastatin sodium 10 MG Oral TabletPSNe7194af1-6304-4e3e-88ab-0825706a39629
904467pravastatin sodium 20 MG Oral TabletPSNe7194af1-6304-4e3e-88ab-0825706a39629
904475pravastatin sodium 40 MG Oral TabletPSNe7194af1-6304-4e3e-88ab-0825706a39629
904458pravastatin sodium 10 MG Oral TabletSCDe7194af1-6304-4e3e-88ab-0825706a39629
904467pravastatin sodium 20 MG Oral TabletSCDe7194af1-6304-4e3e-88ab-0825706a39629
904475pravastatin sodium 40 MG Oral TabletSCDe7194af1-6304-4e3e-88ab-0825706a39629

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
35356-919-303535609193030 TABLET in 1 BOTTLE (35356-919-30) 30 tablet2011-07-182028-04-30NoNoCurrent
35356-919-603535609196060 in 1 BOTTLEHistorical
35356-919-903535609199090 TABLET in 1 BOTTLE (35356-919-90) 90 tablet2011-07-182028-04-30NoNoCurrent