PRAVASTATIN SODIUM

Product NDC
70518-0549
11-digit product format
705180549
Labeler code
70518
Product ID
70518-0549_4d376ba3-ab9c-176d-e063-6394a90a93ee
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PRAVASTATIN SODIUM
Dosage form
TABLET
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA076341
Marketing category
ANDA
Marketing start
2017-05-19
Substance
PRAVASTATIN SODIUM
Active strength
10 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 SODIUM10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii3M8608UQ61
Rxcui904458

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
70518-0549-0PRAVASTATIN SODIUM30 in 1 BLISTER PACKTABLET3018
70518-0549-1PRAVASTATIN SODIUM90 in 1 BOTTLE, PLASTICTABLET9018

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-0549PRAVASTATIN SODIUM TABLET [REMEDYREPACK INC.]13Current NDC, Legacy NDC, 2 package rows20250427_76e5fdf8-bd03-4cd5-9361-e61678cb3de9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
904458pravastatin sodium 10 MG Oral TabletPSN76e5fdf8-bd03-4cd5-9361-e61678cb3de918
904458pravastatin sodium 10 MG Oral TabletSCD76e5fdf8-bd03-4cd5-9361-e61678cb3de918

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-0549-07051805490030 TABLET in 1 BLISTER PACK (70518-0549-0) 30 tablet2017-05-190000-00-00NoNoCurrent
70518-0549-17051805490190 TABLET in 1 BOTTLE, PLASTIC (70518-0549-1) 90 tablet2019-07-100000-00-00NoNoCurrent