Pravastatin Sodium

Product NDC
70518-2505
11-digit product format
705182505
Labeler code
70518
Product ID
70518-2505_4e01137e-8d3a-fd36-e063-6294a90a4363
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pravastatin Sodium
Dosage form
TABLET
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA076056
Marketing category
ANDA
Marketing start
2019-12-24
Marketing end
2026-09-30
Substance
PRAVASTATIN SODIUM
Active strength
40 mg/1
Pharmacologic classes
HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Pravastatin Sodium

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
70518-2505-0Pravastatin Sodium30 in 1 BLISTER PACKTABLET3011
70518-2505-1Pravastatin Sodium90 in 1 BOTTLE, PLASTICTABLET9011

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-2505PRAVASTATIN SODIUM TABLET [REMEDYREPACK INC.]7Current NDC, Legacy NDC, 2 package rows20250319_7e400611-7432-4911-8662-1f0a740f76bb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
904475pravastatin sodium 40 MG Oral TabletPSN7e400611-7432-4911-8662-1f0a740f76bb11
904475pravastatin sodium 40 MG Oral TabletSCD7e400611-7432-4911-8662-1f0a740f76bb11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-2505-07051825050030 TABLET in 1 BLISTER PACK (70518-2505-0) 30 tablet2019-12-240000-00-00NoNoCurrent
70518-2505-17051825050190 TABLET in 1 BOTTLE, PLASTIC (70518-2505-1) 90 tablet2021-01-120000-00-00NoNoCurrent