FDA.reportPublic FDA data

Pravastatin sodium

Product NDC
70518-4408
11-digit product format
705184408
Labeler code
70518
Product ID
70518-4408_3d315367-eb57-02f2-e063-6394a90a72c6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pravastatin sodium
Dosage form
TABLET
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA076056
Marketing category
ANDA
Marketing start
2025-07-28
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
70518-4408-0Pravastatin sodium30 in 1 BLISTER PACKTABLET302
70518-4408-1Pravastatin sodium90 in 1 BOTTLE, PLASTICTABLET902

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
904467pravastatin sodium 20 MG Oral TabletPSN6cef5e92-26b7-435c-878f-72a05a6245602
904467pravastatin sodium 20 MG Oral TabletSCD6cef5e92-26b7-435c-878f-72a05a6245602

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70518-4408-07051844080030 TABLET in 1 BLISTER PACK (70518-4408-0) 30 tablet2025-07-28NoNoCurrent
70518-4408-17051844080190 TABLET in 1 BOTTLE, PLASTIC (70518-4408-1) 90 tablet2025-08-24NoNoCurrent