Pravastatin sodium

Product NDC
50090-7947
11-digit product format
500907947
Labeler code
50090
Product ID
50090-7947_2b31b461-90d2-4f45-ae6d-59e4fe4ad465
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
2025-02-27
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Pravastatin sodium
Listing expiration
2027-12-31

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
50090-7947-0Pravastatin sodium30 in 1 BOTTLETABLET301
50090-7947-1Pravastatin sodium90 in 1 BOTTLETABLET901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-7947-0EA - Each50090-7947262d2086-79b9-4695-864b-ae56d52811bf12026-05-22
50090-7947-1EA - Each50090-7947e81f4e1c-0a22-4fbb-9a0a-e14b3b9ab00e12026-05-22

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
904467pravastatin sodium 20 MG Oral TabletPSNb7f8c679-a602-4268-81b6-962a136a4e431
904467pravastatin sodium 20 MG Oral TabletSCDb7f8c679-a602-4268-81b6-962a136a4e431

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50090-7947-05009079470030 TABLET in 1 BOTTLE (50090-7947-0) 30 tablet2026-04-01NoNoCurrent
50090-7947-15009079470190 TABLET in 1 BOTTLE (50090-7947-1) 90 tablet2026-04-01NoNoCurrent