FDA.reportPublic FDA data

Pravastatin Sodium

Product NDC
50090-0973
11-digit product format
500900973
Labeler code
50090
Product ID
50090-0973_10c73cbe-7f4a-42d2-a81d-95a8bb3d6420
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pravastatin Sodium
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA076056
Marketing category
ANDA
Marketing start
2006-04-25
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
50090-0973-0Pravastatin Sodium30 in 1 BOTTLETABLET301
50090-0973-1Pravastatin Sodium90 in 1 BOTTLETABLET901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-0973-0EA - Each50090-0973e8c7ce84-c704-440d-b5bd-df322cd8320512024-12-10
50090-0973-1EA - Each50090-097395d2f6f9-5d53-4417-ae51-7172197d98c212024-12-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-0973PRAVASTATIN SODIUM TABLET [A-S MEDICATION SOLUTIONS]1Current NDC, 2 package rows20241031_55f8cf43-bf8b-4729-9e5a-32fcc9696e02.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
904467pravastatin sodium 20 MG Oral TabletPSN55f8cf43-bf8b-4729-9e5a-32fcc9696e021
904467pravastatin sodium 20 MG Oral TabletSCD55f8cf43-bf8b-4729-9e5a-32fcc9696e021

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50090-0973-05009009730030 TABLET in 1 BOTTLE (50090-0973-0) 30 tablet2014-11-28NoNoCurrent
50090-0973-15009009730190 TABLET in 1 BOTTLE (50090-0973-1) 90 tablet2014-11-28NoNoCurrent