Pravastatin Sodium

Product NDC
51655-343
11-digit product format
516550343
Labeler code
51655
Product ID
51655-343_48eb3563-bc9a-8be1-e063-6394a90a09b5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pravastatin Sodium
Dosage form
TABLET
Route
ORAL
Labeler
Northwind Health Company, LLC
Application
ANDA076056
Marketing category
ANDA
Marketing start
2023-02-28
Marketing end
2026-09-30
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
Rxcui904467

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
51655-343-52Pravastatin Sodium30 in 1 BOTTLE, PLASTICTABLET303

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51655-343PRAVASTATIN SODIUM TABLET [NORTHWIND PHARMACEUTICALS, LLC]2Current NDC, 1 package rows20240718_f6ddb6c0-d0b4-2297-e053-6294a90a83c9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
904467pravastatin sodium 20 MG Oral TabletPSNf6ddb6c0-d0b4-2297-e053-6294a90a83c93
904467pravastatin sodium 20 MG Oral TabletSCDf6ddb6c0-d0b4-2297-e053-6294a90a83c93

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51655-343-525165503435230 TABLET in 1 BOTTLE, PLASTIC (51655-343-52) 30 tablet2023-02-282026-09-30NoNoHistorical