PRAVASTATIN SODIUM

Product NDC
70518-0876
11-digit product format
705180876
Labeler code
70518
Product ID
70518-0876_4d39e445-8eca-edee-e063-6394a90a04f5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PRAVASTATIN SODIUM
Dosage form
TABLET
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA076341
Marketing category
ANDA
Marketing start
2017-11-29
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
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 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
70518-0876-0PRAVASTATIN SODIUM90 in 1 BOTTLE, PLASTICTABLET9020
70518-0876-1PRAVASTATIN SODIUM30 in 1 BLISTER PACKTABLET3020
70518-0876-2PRAVASTATIN SODIUM45 in 1 BOTTLE, PLASTICTABLET4520

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-0876PRAVASTATIN SODIUM TABLET [REMEDYREPACK INC.]15Current NDC, Legacy NDC, 3 package rows20250503_5ecd9fd1-7662-412d-99c5-13c77188748c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
904475pravastatin sodium 40 MG Oral TabletPSN5ecd9fd1-7662-412d-99c5-13c77188748c20
904475pravastatin sodium 40 MG Oral TabletSCD5ecd9fd1-7662-412d-99c5-13c77188748c20

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-0876-07051808760090 TABLET in 1 BOTTLE, PLASTIC (70518-0876-0) 90 tablet2017-11-290000-00-00NoNoCurrent
70518-0876-17051808760130 in 1 BLISTER PACKHistorical
70518-0876-27051808760245 in 1 BOTTLE, PLASTICHistorical