FDA.reportPublic FDA data

PRAVASTATIN SODIUM

Product NDC
71335-9692
11-digit product format
713359692
Labeler code
71335
Product ID
71335-9692_3546b058-eaa7-8ab0-e063-6294a90a16ff
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PRAVASTATIN SODIUM
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA209869
Marketing category
ANDA
Marketing start
2021-02-01
Substance
PRAVASTATIN SODIUM
Active strength
20 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
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PRAVASTATIN SODIUM20 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii3M8608UQ61
Rxcui904467

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
36361c23-a766-1581-d616-2080c781a50cProduct name520190314
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-9692-1PRAVASTATIN SODIUM30 in 1 BOTTLETABLET30101
71335-9692-2PRAVASTATIN SODIUM90 in 1 BOTTLETABLET90101
71335-9692-3PRAVASTATIN SODIUM100 in 1 BOTTLETABLET100101
71335-9692-4PRAVASTATIN SODIUM60 in 1 BOTTLETABLET60101
71335-9692-5PRAVASTATIN SODIUM10 in 1 BOTTLETABLET10101

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-9692PRAVASTATIN SODIUM TABLET [BRYANT RANCH PREPACK]101Current NDC, 5 package rows20250519_ca7a4143-0091-4cd5-9061-cb05cc84ea4e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
904467pravastatin sodium 20 MG Oral TabletPSNca7a4143-0091-4cd5-9061-cb05cc84ea4e101
904467pravastatin sodium 20 MG Oral TabletSCDca7a4143-0091-4cd5-9061-cb05cc84ea4e101

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71335-9692-17133596920130 TABLET in 1 BOTTLE (71335-9692-1) 30 tablet2023-04-18NoNoCurrent
71335-9692-27133596920290 TABLET in 1 BOTTLE (71335-9692-2) 90 tablet2023-04-18NoNoCurrent
71335-9692-371335969203100 TABLET in 1 BOTTLE (71335-9692-3) 100 tablet2023-04-18NoNoCurrent
71335-9692-47133596920460 TABLET in 1 BOTTLE (71335-9692-4) 60 tablet2023-04-18NoNoCurrent
71335-9692-57133596920510 TABLET in 1 BOTTLE (71335-9692-5) 10 tablet2023-04-18NoNoCurrent