Pravastatin Sodium

Product NDC
55154-5370
11-digit product format
551545370
Labeler code
55154
Product ID
55154-5370_d74e39c9-d5f8-4098-9fa0-a7508fb89755
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pravastatin Sodium
Dosage form
TABLET
Route
ORAL
Labeler
Cardinal Health 107, LLC
Application
ANDA076056
Marketing category
ANDA
Marketing start
2012-02-10
Marketing end
2026-08-31
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
Rxcui904467, 904475

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
55154-5370-0Pravastatin Sodium1 in 1 BLISTER PACKTABLET115
55154-5370-0Pravastatin Sodium10 in 1 BAGTABLET1015

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PRAVASTATIN SODIUMACTIVE INGREDIENT3M8608UQ61PRAVASTATIN SODIUM TABLET [CARDINAL HEALTH]3
PRAVASTATINACTIVE MOIETYKXO2KT9N0GPRAVASTATIN SODIUM TABLET [CARDINAL HEALTH]3
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSINACTIVE INGREDIENTL11K75P92JPRAVASTATIN SODIUM TABLET [CARDINAL HEALTH]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UPRAVASTATIN SODIUM TABLET [CARDINAL HEALTH]3
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48PRAVASTATIN SODIUM TABLET [CARDINAL HEALTH]3
CROSPOVIDONEINACTIVE INGREDIENT68401960MKPRAVASTATIN SODIUM TABLET [CARDINAL HEALTH]3
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GPRAVASTATIN SODIUM TABLET [CARDINAL HEALTH]3
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDPRAVASTATIN SODIUM TABLET [CARDINAL HEALTH]3
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTPRAVASTATIN SODIUM TABLET [CARDINAL HEALTH]3
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GPRAVASTATIN SODIUM TABLET [CARDINAL HEALTH]3
POVIDONESINACTIVE INGREDIENTFZ989GH94EPRAVASTATIN SODIUM TABLET [CARDINAL HEALTH]3
SODIUM STEARYL FUMARATEINACTIVE INGREDIENT7CV7WJK4UIPRAVASTATIN SODIUM TABLET [CARDINAL HEALTH]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55154-5370PRAVASTATIN SODIUM TABLET [CARDINAL HEALTH 107, LLC]14Current NDC, Legacy NDC, 2 package rows20240629_ca779f66-4b9d-41da-ad0e-e4f58db9fbac.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
904467pravastatin sodium 20 MG Oral TabletPSNca779f66-4b9d-41da-ad0e-e4f58db9fbac15
904475pravastatin sodium 40 MG Oral TabletPSNca779f66-4b9d-41da-ad0e-e4f58db9fbac15
904467pravastatin sodium 20 MG Oral TabletSCDca779f66-4b9d-41da-ad0e-e4f58db9fbac15
904475pravastatin sodium 40 MG Oral TabletSCDca779f66-4b9d-41da-ad0e-e4f58db9fbac15

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55154-5370-05515453700010 BLISTER PACK in 1 BAG (55154-5370-0) / 1 TABLET in 1 BLISTER PACK10 blister pack2012-02-102026-08-31NoNoCurrent