FDA.reportPublic FDA data

Pravastatin Sodium

Product NDC
50090-0975
11-digit product format
500900975
Labeler code
50090
Product ID
50090-0975_e0a2b342-26bb-4c86-b9c4-20fc5160c98f
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
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
50090-0975-0Pravastatin Sodium30 in 1 BOTTLETABLET3010
50090-0975-1Pravastatin Sodium90 in 1 BOTTLETABLET9010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-0975-0EA - Each50090-0975faf5d28a-037b-41ab-9924-005e34d8bf7712023-05-05
50090-0975-1EA - Each50090-09759c07dbfe-4c07-4175-95ae-06c8ed7429fd12023-05-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-0975PRAVASTATIN SODIUM TABLET [A-S MEDICATION SOLUTIONS]10Current NDC, Legacy NDC, 2 package rows20231215_a75de063-c751-4647-bb9e-d4050c1e31fc.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
904467pravastatin sodium 20 MG Oral TabletPSNa75de063-c751-4647-bb9e-d4050c1e31fc10
904467pravastatin sodium 20 MG Oral TabletSCDa75de063-c751-4647-bb9e-d4050c1e31fc10

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50090-0975-05009009750030 TABLET in 1 BOTTLE (50090-0975-0) 30 tablet2014-11-28NoNoCurrent
50090-0975-15009009750190 TABLET in 1 BOTTLE (50090-0975-1) 90 tablet2014-11-28NoNoCurrent