PRAVASTATIN SODIUM

Product NDC
63629-8833
11-digit product format
636298833
Labeler code
63629
Product ID
63629-8833_167a2550-ca7b-4990-8c0f-5922af045614
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PRAVASTATIN SODIUM
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA076341
Marketing category
ANDA
Marketing start
2011-07-18
Substance
PRAVASTATIN SODIUM
Active strength
10 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 SODIUM10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii3M8608UQ61
Rxcui904458

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
63629-8833-1PRAVASTATIN SODIUM90 in 1 BOTTLETABLET90107

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-8833-1EA - Each63629-8833322f2c4f-8013-4950-97b4-8e06988893e812021-12-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-8833PRAVASTATIN SODIUM TABLET [BRYANT RANCH PREPACK]106Current NDC, Legacy NDC, 1 package rows20250216_2ba7af14-9c87-4eb0-84c9-7e895cd75fae.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
904458pravastatin sodium 10 MG Oral TabletPSN2ba7af14-9c87-4eb0-84c9-7e895cd75fae107
904458pravastatin sodium 10 MG Oral TabletSCD2ba7af14-9c87-4eb0-84c9-7e895cd75fae107

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-8833-16362988330190 TABLET in 1 BOTTLE (63629-8833-1) 90 tablet2011-07-180000-00-00NoNoCurrent