PRAVASTATIN SODIUM

Product NDC
68788-7009
11-digit product format
687887009
Labeler code
68788
Product ID
68788-7009_69f31017-0c07-4b6f-8989-9917171a3e73
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
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
Rxcui904475

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
68788-7009-1PRAVASTATIN SODIUM100 in 1 BOTTLETABLET1004
68788-7009-2PRAVASTATIN SODIUM20 in 1 BOTTLETABLET204
68788-7009-3PRAVASTATIN SODIUM30 in 1 BOTTLETABLET304
68788-7009-6PRAVASTATIN SODIUM60 in 1 BOTTLETABLET604
68788-7009-8PRAVASTATIN SODIUM120 in 1 BOTTLETABLET1204
68788-7009-9PRAVASTATIN SODIUM90 in 1 BOTTLETABLET904

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-7009PRAVASTATIN SODIUM TABLET [PREFERRED PHARMACEUTICALS INC.]3Current NDC, Legacy NDC, 6 package rows20240731_46cdd32d-a022-4acf-ba2b-10e7877d56c6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
904475pravastatin sodium 40 MG Oral TabletPSN46cdd32d-a022-4acf-ba2b-10e7877d56c64
904475pravastatin sodium 40 MG Oral TabletSCD46cdd32d-a022-4acf-ba2b-10e7877d56c64

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68788-7009-168788700901100 TABLET in 1 BOTTLE (68788-7009-1) 100 tablet2022-09-270000-00-00NoNoCurrent
68788-7009-26878870090220 TABLET in 1 BOTTLE (68788-7009-2) 20 tablet2022-09-270000-00-00NoNoCurrent
68788-7009-36878870090330 TABLET in 1 BOTTLE (68788-7009-3) 30 tablet2022-09-270000-00-00NoNoCurrent
68788-7009-66878870090660 TABLET in 1 BOTTLE (68788-7009-6) 60 tablet2022-09-270000-00-00NoNoCurrent
68788-7009-868788700908120 TABLET in 1 BOTTLE (68788-7009-8) 120 tablet2022-09-270000-00-00NoNoCurrent
68788-7009-96878870090990 TABLET in 1 BOTTLE (68788-7009-9) 90 tablet2022-09-270000-00-00NoNoCurrent