FDA.reportPublic FDA data

PRAVASTATIN SODIUM

Product NDC
68788-7779
11-digit product format
687887779
Labeler code
68788
Product ID
68788-7779_5934c3b6-a062-4c70-bd07-87d40980369a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PRAVASTATIN SODIUM
Dosage form
TABLET
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA076341
Marketing category
ANDA
Marketing start
2022-09-27
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
2026-12-31

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
36361c23-a766-1581-d616-2080c781a50cProduct name520190314

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68788-7779-3PRAVASTATIN SODIUM90 in 1 BOTTLETABLET904
68788-7779-6PRAVASTATIN SODIUM100 in 1 BOTTLETABLET1004
68788-7779-9PRAVASTATIN SODIUM500 in 1 BOTTLETABLET5004

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-7779-3EA - Each68788-77798c2341d3-8109-432f-8a20-f1af0dc9997d12022-10-06
68788-7779-6EA - Each68788-77797bdd584e-fbf6-49e2-bf91-4f968df09e5f12022-10-06
68788-7779-9EA - Each68788-77797b0ec36a-7963-47d3-b57a-4edf9f615fb212022-10-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-7779PRAVASTATIN SODIUM TABLET [PREFERRED PHARMACEUTICALS INC.]3Current NDC, Legacy NDC, 3 package rows20240731_6d42bd30-1f09-49f4-9ec8-31366df1b4b4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
904467pravastatin sodium 20 MG Oral TabletPSN6d42bd30-1f09-49f4-9ec8-31366df1b4b44
904467pravastatin sodium 20 MG Oral TabletSCD6d42bd30-1f09-49f4-9ec8-31366df1b4b44

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68788-7779-36878877790390 TABLET in 1 BOTTLE (68788-7779-3) 90 tablet2022-09-270000-00-00NoNoCurrent
68788-7779-668788777906100 TABLET in 1 BOTTLE (68788-7779-6) 100 tablet2022-09-270000-00-00NoNoCurrent
68788-7779-968788777909500 TABLET in 1 BOTTLE (68788-7779-9) 500 tablet2022-09-270000-00-00NoNoCurrent