Pravastatin sodium

Product NDC
70518-4339
11-digit product format
705184339
Labeler code
70518
Product ID
70518-4339_4030e199-7260-81fc-e063-6394a90a315b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pravastatin sodium
Dosage form
TABLET
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA076056
Marketing category
ANDA
Marketing start
2025-05-13
Substance
PRAVASTATIN SODIUM
Active strength
40 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 SODIUM40 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii3M8608UQ61
Rxcui904475

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
70518-4339-0Pravastatin sodium30 in 1 BLISTER PACKTABLET303
70518-4339-1Pravastatin sodium90 in 1 BOTTLE, PLASTICTABLET903

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-4339PRAVASTATIN SODIUM TABLET [REMEDYREPACK INC.]1Current NDC, 2 package rows20250523_fa152ce7-6c07-4aaf-9374-932ce81d0cf9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
904475pravastatin sodium 40 MG Oral TabletPSNfa152ce7-6c07-4aaf-9374-932ce81d0cf93
904475pravastatin sodium 40 MG Oral TabletSCDfa152ce7-6c07-4aaf-9374-932ce81d0cf93

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70518-4339-07051843390030 TABLET in 1 BLISTER PACK (70518-4339-0) 30 tablet2025-05-13NoNoCurrent
70518-4339-17051843390190 TABLET in 1 BOTTLE, PLASTIC (70518-4339-1) 90 tablet2025-08-25NoNoCurrent