Pravastatin Sodium

Product NDC
60687-178
11-digit product format
606870178
Labeler code
60687
Product ID
60687-178_2d66db06-3497-4b8d-e063-6294a90a3180
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pravastatin Sodium
Dosage form
TABLET
Route
ORAL
Labeler
American Health Packaging
Application
ANDA077987
Marketing category
ANDA
Marketing start
2017-02-14
Marketing end
2026-08-31
Substance
PRAVASTATIN SODIUM
Active strength
20 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 SODIUM20 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii3M8608UQ61
Rxcui904458, 904467, 904475

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
36361c23-a766-1581-d616-2080c781a50cProduct name520190314
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
60687-178-01Pravastatin Sodium100 in 1 BOX, UNIT-DOSETABLET10014
60687-178-11Pravastatin Sodium1 in 1 BLISTER PACKTABLET114

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60687-178PRAVASTATIN SODIUM TABLET [AMERICAN HEALTH PACKAGING]14Current NDC, Legacy NDC, 2 package rows20250207_056475c8-59c2-469c-9175-7162065726f5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
904458pravastatin sodium 10 MG Oral TabletPSN056475c8-59c2-469c-9175-7162065726f514
904467pravastatin sodium 20 MG Oral TabletPSN056475c8-59c2-469c-9175-7162065726f514
904475pravastatin sodium 40 MG Oral TabletPSN056475c8-59c2-469c-9175-7162065726f514
904458pravastatin sodium 10 MG Oral TabletSCD056475c8-59c2-469c-9175-7162065726f514
904467pravastatin sodium 20 MG Oral TabletSCD056475c8-59c2-469c-9175-7162065726f514
904475pravastatin sodium 40 MG Oral TabletSCD056475c8-59c2-469c-9175-7162065726f514

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
60687-178-0160687017801100 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-178-01) / 1 TABLET in 1 BLISTER PACK (60687-178-11) 100 blister pack2017-02-142026-08-31NoNoCurrent
60687-178-11606870178111 in 1 BLISTER PACKHistorical