Pravastatin sodium

Product NDC
68788-4059
11-digit product format
687884059
Labeler code
68788
Product ID
68788-4059_f92e12bc-40c3-4afa-9190-2f4de11ec6b3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pravastatin sodium
Dosage form
TABLET
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA076056
Marketing category
ANDA
Marketing start
2025-12-08
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
68788-4059-3Pravastatin sodium30 in 1 BOTTLETABLET301
68788-4059-6Pravastatin sodium60 in 1 BOTTLETABLET601
68788-4059-9Pravastatin sodium90 in 1 BOTTLETABLET901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-4059-3EA - Each68788-4059f913cb43-bddc-4677-a741-d5dfd51af3cb12026-03-17
68788-4059-6EA - Each68788-405983de8805-7778-4256-99b3-b6cf73cef2af12026-03-17
68788-4059-9EA - Each68788-4059c6eca1c0-1d7d-4ebb-a2c6-5de2623fe3fe12026-03-17

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
904458pravastatin sodium 10 MG Oral TabletPSNf92e12bc-40c3-4afa-9190-2f4de11ec6b31
904458pravastatin sodium 10 MG Oral TabletSCDf92e12bc-40c3-4afa-9190-2f4de11ec6b31

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68788-4059-36878840590330 TABLET in 1 BOTTLE (68788-4059-3) 30 tablet2025-12-08NoNoHistorical
68788-4059-66878840590660 TABLET in 1 BOTTLE (68788-4059-6) 60 tablet2025-12-08NoNoHistorical
68788-4059-96878840590990 TABLET in 1 BOTTLE (68788-4059-9) 90 tablet2025-12-08NoNoHistorical