FDA.reportPublic FDA data

Pravastatin Sodium

Product NDC
50090-7551
11-digit product format
500907551
Labeler code
50090
Product ID
50090-7551_a147a04b-630a-4280-9663-fef59cc8fef0
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
2022-08-12
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
50090-7551-0Pravastatin Sodium30 in 1 BOTTLETABLET301
50090-7551-1Pravastatin Sodium90 in 1 BOTTLETABLET901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-7551-0EA - Each50090-7551c67ad2ba-0559-4c99-9588-96c28f4ae13512025-06-13
50090-7551-1EA - Each50090-7551df9571b6-7f4d-436b-9a1e-a0607949f4cc12025-06-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-7551PRAVASTATIN SODIUM TABLET [A-S MEDICATION SOLUTIONS]1Current NDC, 2 package rows20250529_b7a84cc1-f6e4-40be-9e68-cf7d43bbd617.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
904467pravastatin sodium 20 MG Oral TabletPSNb7a84cc1-f6e4-40be-9e68-cf7d43bbd6171
904467pravastatin sodium 20 MG Oral TabletSCDb7a84cc1-f6e4-40be-9e68-cf7d43bbd6171

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50090-7551-05009075510030 TABLET in 1 BOTTLE (50090-7551-0) 30 tablet2025-05-23NoNoCurrent
50090-7551-15009075510190 TABLET in 1 BOTTLE (50090-7551-1) 90 tablet2025-05-23NoNoCurrent