FDA.reportPublic FDA data

PRAVASTATIN SODIUM

Product NDC
71205-516
11-digit product format
712050516
Labeler code
71205
Product ID
71205-516_d1c530da-d15b-4ffc-b2b4-cd1e4dd5e8ee
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PRAVASTATIN SODIUM
Dosage form
TABLET
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA076341
Marketing category
ANDA
Marketing start
2011-07-18
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

Additional Listing Data#

Finished product
Yes
Brand name base
PRAVASTATIN SODIUM
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PRAVASTATIN SODIUM40 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii3M8608UQ61
Rxcui904475

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
71205-516-30PRAVASTATIN SODIUM30 in 1 BOTTLETABLET302
71205-516-60PRAVASTATIN SODIUM60 in 1 BOTTLETABLET602
71205-516-90PRAVASTATIN SODIUM90 in 1 BOTTLETABLET902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-516-30EA - Each71205-516c43daa3e-6298-43d6-8baf-1bd8b1aef0c712021-02-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-516PRAVASTATIN SODIUM TABLET [PROFICIENT RX LP]2Current NDC, Legacy NDC, 3 package rows20220331_2bdfb0ef-2455-4ca2-a117-ce8e26bb2dbc.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
904475pravastatin sodium 40 MG Oral TabletPSN2bdfb0ef-2455-4ca2-a117-ce8e26bb2dbc2
904475pravastatin sodium 40 MG Oral TabletSCD2bdfb0ef-2455-4ca2-a117-ce8e26bb2dbc2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71205-516-307120505163030 TABLET in 1 BOTTLE (71205-516-30) 30 tablet2020-12-240000-00-00NoNoCurrent
71205-516-607120505166060 TABLET in 1 BOTTLE (71205-516-60) 60 tablet2020-12-240000-00-00NoNoCurrent
71205-516-907120505169090 TABLET in 1 BOTTLE (71205-516-90) 90 tablet2020-12-240000-00-00NoNoCurrent