FDA.reportPublic FDA data

PRAVASTATIN SODIUM

Product NDC
0904-5891
11-digit product format
009045891
Labeler code
0904
Product ID
0904-5891_1fc88a70-8c13-4db5-97e5-e0f356ce65aa
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PRAVASTATIN SODIUM
Dosage form
TABLET
Route
ORAL
Labeler
Major Pharmaceuticals
Application
ANDA076341
Marketing category
ANDA
Marketing start
2011-07-18
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, 904467, 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
0904-5891-61PRAVASTATIN SODIUM1 in 1 BLISTER PACKTABLET115
0904-5891-61PRAVASTATIN SODIUM100 in 1 BOX, UNIT-DOSETABLET10015

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-5891-61EA - Each0904-5891d5f8e555-6739-4f1d-b19c-b58d5673905412013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PRAVASTATIN SODIUMACTIVE INGREDIENT3M8608UQ61PRAVASTATIN SODIUM TABLET [MAJOR PHARMACEUTICALS]5
PRAVASTATINACTIVE MOIETYKXO2KT9N0GPRAVASTATIN SODIUM TABLET [MAJOR PHARMACEUTICALS]5
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UPRAVASTATIN SODIUM TABLET [MAJOR PHARMACEUTICALS]5
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48PRAVASTATIN SODIUM TABLET [MAJOR PHARMACEUTICALS]5
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDPRAVASTATIN SODIUM TABLET [MAJOR PHARMACEUTICALS]5
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675PRAVASTATIN SODIUM TABLET [MAJOR PHARMACEUTICALS]5
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTPRAVASTATIN SODIUM TABLET [MAJOR PHARMACEUTICALS]5
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XPRAVASTATIN SODIUM TABLET [MAJOR PHARMACEUTICALS]5
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PRAVASTATIN SODIUM TABLET [MAJOR PHARMACEUTICALS]5
PRAVASTATIN SODIUMACTIVE INGREDIENT3M8608UQ61PRAVASTATIN SODIUM TABLET [CARDINAL HEALTH]2
PRAVASTATINACTIVE MOIETYKXO2KT9N0GPRAVASTATIN SODIUM TABLET [CARDINAL HEALTH]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UPRAVASTATIN SODIUM TABLET [CARDINAL HEALTH]2
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48PRAVASTATIN SODIUM TABLET [CARDINAL HEALTH]2
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675PRAVASTATIN SODIUM TABLET [CARDINAL HEALTH]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XPRAVASTATIN SODIUM TABLET [CARDINAL HEALTH]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PRAVASTATIN SODIUM TABLET [CARDINAL HEALTH]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0904-5891PRAVASTATIN SODIUM TABLET [MAJOR PHARMACEUTICALS]13Current NDC, Legacy NDC, 2 package rows20250214_1d5bce9c-a788-4c52-a69e-c53174b8d061.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
904458pravastatin sodium 10 MG Oral TabletPSN1d5bce9c-a788-4c52-a69e-c53174b8d06115
904467pravastatin sodium 20 MG Oral TabletPSN1d5bce9c-a788-4c52-a69e-c53174b8d06115
904475pravastatin sodium 40 MG Oral TabletPSN1d5bce9c-a788-4c52-a69e-c53174b8d06115
904458pravastatin sodium 10 MG Oral TabletSCD1d5bce9c-a788-4c52-a69e-c53174b8d06115
904467pravastatin sodium 20 MG Oral TabletSCD1d5bce9c-a788-4c52-a69e-c53174b8d06115
904475pravastatin sodium 40 MG Oral TabletSCD1d5bce9c-a788-4c52-a69e-c53174b8d06115
904458pravastatin sodium 10 MG Oral TabletPSN3e218ad6-5b47-4cca-81be-ebaea57959645
904458pravastatin sodium 10 MG Oral TabletSCD3e218ad6-5b47-4cca-81be-ebaea57959645

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0904-5891-6100904589161100 BLISTER PACK in 1 BOX, UNIT-DOSE (0904-5891-61) / 1 TABLET in 1 BLISTER PACK100 blister pack2011-07-180000-00-00NoNoCurrent