FDA.reportPublic FDA data

PRAVASTATIN SODIUM

Product NDC
82009-007
11-digit product format
820090007
Labeler code
82009
Product ID
82009-007_edcdc136-1cb4-26ac-2dc7-fcf26c4b5319
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PRAVASTATIN SODIUM
Dosage form
TABLET
Route
ORAL
Labeler
Quallent
Application
ANDA076341
Marketing category
ANDA
Marketing start
2021-12-03
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
Rxcui904467, 904475, 904481

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
82009-007-10PRAVASTATIN SODIUM1000 in 1 BOTTLETABLET10008
82009-007-90PRAVASTATIN SODIUM90 in 1 BOTTLETABLET908

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
82009-007-10EA - Each82009-0076cc52046-1e2b-4123-8ef6-3be12882172912021-12-08
82009-007-90EA - Each82009-007431418e4-dc6e-4383-8d3d-d22eeb25bacb12021-12-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82009-007PRAVASTATIN SODIUM TABLET [QUALLENT]7Current NDC, Legacy NDC, 2 package rows20241228_e9c188f7-cd6f-afac-b493-36552d86589e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
904467pravastatin sodium 20 MG Oral TabletPSNe9c188f7-cd6f-afac-b493-36552d86589e8
904475pravastatin sodium 40 MG Oral TabletPSNe9c188f7-cd6f-afac-b493-36552d86589e8
904481pravastatin sodium 80 MG Oral TabletPSNe9c188f7-cd6f-afac-b493-36552d86589e8
904467pravastatin sodium 20 MG Oral TabletSCDe9c188f7-cd6f-afac-b493-36552d86589e8
904475pravastatin sodium 40 MG Oral TabletSCDe9c188f7-cd6f-afac-b493-36552d86589e8
904481pravastatin sodium 80 MG Oral TabletSCDe9c188f7-cd6f-afac-b493-36552d86589e8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
82009-007-10820090007101000 TABLET in 1 BOTTLE (82009-007-10) 1000 tablet2021-12-030000-00-00NoNoCurrent
82009-007-908200900079090 TABLET in 1 BOTTLE (82009-007-90) 90 tablet2021-12-030000-00-00NoNoCurrent