FDA.reportPublic FDA data

Pravastatin Sodium

Product NDC
50090-1594
11-digit product format
500901594
Labeler code
50090
Product ID
50090-1594_8b71204c-39a3-472e-a755-b00e6baf26f9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pravastatin Sodium
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA077987
Marketing category
ANDA
Marketing start
2007-05-11
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, 904475

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
50090-1594-0Pravastatin Sodium90 in 1 BOTTLETABLET9015
50090-1594-1Pravastatin Sodium30 in 1 BOTTLETABLET3015

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-1594-0EA - Each50090-159463fc6518-485a-41b4-8f81-deea90555e4e12018-11-06
50090-1594-1EA - Each50090-1594316a033e-fbba-48c5-8889-cd7bac2ab17112018-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-1594PRAVASTATIN SODIUM TABLET [A-S MEDICATION SOLUTIONS]15Current NDC, Legacy NDC, 2 package rows20250502_bdf02140-3647-498e-ba0a-f4ca920b4e90.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
904458pravastatin sodium 10 MG Oral TabletPSNbdf02140-3647-498e-ba0a-f4ca920b4e9015
904475pravastatin sodium 40 MG Oral TabletPSNbdf02140-3647-498e-ba0a-f4ca920b4e9015
904458pravastatin sodium 10 MG Oral TabletSCDbdf02140-3647-498e-ba0a-f4ca920b4e9015
904475pravastatin sodium 40 MG Oral TabletSCDbdf02140-3647-498e-ba0a-f4ca920b4e9015

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50090-1594-05009015940090 TABLET in 1 BOTTLE (50090-1594-0) 90 tablet2015-01-05NoNoHistorical
50090-1594-15009015940130 TABLET in 1 BOTTLE (50090-1594-1) 30 tablet2015-01-05NoNoHistorical