FDA.reportPublic FDA data

PRAVASTATIN SODIUM

Product NDC
60505-0168
11-digit product format
605050168
Labeler code
60505
Product ID
60505-0168_4ee96b96-8019-3bb3-6737-f6f88c6289d9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PRAVASTATIN SODIUM
Dosage form
TABLET
Route
ORAL
Labeler
Apotex Corp.
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, 904481

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
60505-0168-1PRAVASTATIN SODIUM100 in 1 BOTTLETABLET10018
60505-0168-4PRAVASTATIN SODIUM40000 in 1 BOTTLETABLET4000018
60505-0168-5PRAVASTATIN SODIUM500 in 1 BOTTLETABLET50018
60505-0168-7PRAVASTATIN SODIUM1000 in 1 BOTTLETABLET100018
60505-0168-9PRAVASTATIN SODIUM90 in 1 BOTTLETABLET9018

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60505-0168-5EA - Each60505-0168667abd48-648e-41bf-99c2-e657f5b4dcbb12012-07-24
60505-0168-9EA - Each60505-016875a2ec7b-b94a-46ad-833a-56b0693c9caa12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PRAVASTATIN SODIUMACTIVE INGREDIENT3M8608UQ61PRAVASTATIN SODIUM TABLET [APOTEX CORP.]6
PRAVASTATINACTIVE MOIETYKXO2KT9N0GPRAVASTATIN SODIUM TABLET [APOTEX CORP.]6
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UPRAVASTATIN SODIUM TABLET [APOTEX CORP.]6
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48PRAVASTATIN SODIUM TABLET [APOTEX CORP.]6
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDPRAVASTATIN SODIUM TABLET [APOTEX CORP.]6
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675PRAVASTATIN SODIUM TABLET [APOTEX CORP.]6
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTPRAVASTATIN SODIUM TABLET [APOTEX CORP.]6
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XPRAVASTATIN SODIUM TABLET [APOTEX CORP.]6
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PRAVASTATIN SODIUM TABLET [APOTEX CORP.]6
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 [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]1
pravastatinACTIVE MOIETYKXO2KT9N0GPRAVASTATIN SODIUM TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]1
cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61UPRAVASTATIN SODIUM TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]1
croscarmellose sodiumINACTIVE INGREDIENTM28OL1HH48PRAVASTATIN SODIUM TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]1
FD&C Blue No. 1INACTIVE INGREDIENTH3R47K3TBDPRAVASTATIN SODIUM TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]1
Ferric Oxide RedINACTIVE INGREDIENT1K09F3G675PRAVASTATIN SODIUM TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]1
Ferric Oxide YellowINACTIVE INGREDIENTEX438O2MRTPRAVASTATIN SODIUM TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]1
lactose monohydrateINACTIVE INGREDIENTEWQ57Q8I5XPRAVASTATIN SODIUM TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]1
magnesium stearateINACTIVE INGREDIENT70097M6I30PRAVASTATIN SODIUM TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60505-0168PRAVASTATIN SODIUM TABLET [APOTEX CORP.]16Current NDC, Legacy NDC, 5 package rows20241211_dcf45e4f-b46e-6fbb-b67a-2ff619ab1780.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
904458pravastatin sodium 10 MG Oral TabletPSN7b900a28-f20e-49d5-98a9-5513fee0a901107
904458pravastatin sodium 10 MG Oral TabletPSN2ba7af14-9c87-4eb0-84c9-7e895cd75fae107
904458pravastatin sodium 10 MG Oral TabletSCD2ba7af14-9c87-4eb0-84c9-7e895cd75fae107
904458pravastatin sodium 10 MG Oral TabletSCD7b900a28-f20e-49d5-98a9-5513fee0a901107
904458pravastatin sodium 10 MG Oral TabletPSNf4b330ce-dfb0-4e4e-9f37-482458820c66104
904458pravastatin sodium 10 MG Oral TabletSCDf4b330ce-dfb0-4e4e-9f37-482458820c66104
904458pravastatin sodium 10 MG Oral TabletPSN76e5fdf8-bd03-4cd5-9361-e61678cb3de918
904458pravastatin sodium 10 MG Oral TabletPSNdcf45e4f-b46e-6fbb-b67a-2ff619ab178018
904467pravastatin sodium 20 MG Oral TabletPSNdcf45e4f-b46e-6fbb-b67a-2ff619ab178018
904475pravastatin sodium 40 MG Oral TabletPSNdcf45e4f-b46e-6fbb-b67a-2ff619ab178018
904481pravastatin sodium 80 MG Oral TabletPSNdcf45e4f-b46e-6fbb-b67a-2ff619ab178018
904458pravastatin sodium 10 MG Oral TabletSCD76e5fdf8-bd03-4cd5-9361-e61678cb3de918
904458pravastatin sodium 10 MG Oral TabletSCDdcf45e4f-b46e-6fbb-b67a-2ff619ab178018
904467pravastatin sodium 20 MG Oral TabletSCDdcf45e4f-b46e-6fbb-b67a-2ff619ab178018
904475pravastatin sodium 40 MG Oral TabletSCDdcf45e4f-b46e-6fbb-b67a-2ff619ab178018
904481pravastatin sodium 80 MG Oral TabletSCDdcf45e4f-b46e-6fbb-b67a-2ff619ab178018
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 TabletPSN3e6d1c1e-d5f7-42ec-bcdd-8fc310acdf2111
904458pravastatin sodium 10 MG Oral TabletSCD3e6d1c1e-d5f7-42ec-bcdd-8fc310acdf2111
904458pravastatin sodium 10 MG Oral TabletPSNe7194af1-6304-4e3e-88ab-0825706a39629
904467pravastatin sodium 20 MG Oral TabletPSNe7194af1-6304-4e3e-88ab-0825706a39629
904475pravastatin sodium 40 MG Oral TabletPSNe7194af1-6304-4e3e-88ab-0825706a39629
904458pravastatin sodium 10 MG Oral TabletSCDe7194af1-6304-4e3e-88ab-0825706a39629
904467pravastatin sodium 20 MG Oral TabletSCDe7194af1-6304-4e3e-88ab-0825706a39629
904475pravastatin sodium 40 MG Oral TabletSCDe7194af1-6304-4e3e-88ab-0825706a39629
904458pravastatin sodium 10 MG Oral TabletPSNba4ac602-46fa-8386-e053-2995a90a97646
904467pravastatin sodium 20 MG Oral TabletPSNba4ac602-46fa-8386-e053-2995a90a97646
904475pravastatin sodium 40 MG Oral TabletPSNba4ac602-46fa-8386-e053-2995a90a97646
904481pravastatin sodium 80 MG Oral TabletPSNba4ac602-46fa-8386-e053-2995a90a97646
904458pravastatin sodium 10 MG Oral TabletSCDba4ac602-46fa-8386-e053-2995a90a97646
904467pravastatin sodium 20 MG Oral TabletSCDba4ac602-46fa-8386-e053-2995a90a97646
904475pravastatin sodium 40 MG Oral TabletSCDba4ac602-46fa-8386-e053-2995a90a97646
904481pravastatin sodium 80 MG Oral TabletSCDba4ac602-46fa-8386-e053-2995a90a97646
904458pravastatin sodium 10 MG Oral TabletPSN97178675-3691-2d93-e053-2995a90aa5c15
904467pravastatin sodium 20 MG Oral TabletPSN97178675-3691-2d93-e053-2995a90aa5c15
904475pravastatin sodium 40 MG Oral TabletPSN97178675-3691-2d93-e053-2995a90aa5c15
904481pravastatin sodium 80 MG Oral TabletPSN97178675-3691-2d93-e053-2995a90aa5c15
904458pravastatin sodium 10 MG Oral TabletSCD97178675-3691-2d93-e053-2995a90aa5c15
904467pravastatin sodium 20 MG Oral TabletSCD97178675-3691-2d93-e053-2995a90aa5c15
904475pravastatin sodium 40 MG Oral TabletSCD97178675-3691-2d93-e053-2995a90aa5c15
904481pravastatin sodium 80 MG Oral TabletSCD97178675-3691-2d93-e053-2995a90aa5c15
904458pravastatin sodium 10 MG Oral TabletPSN8ed7879d-988c-1a27-e053-2995a90a03613
904458pravastatin sodium 10 MG Oral TabletPSN8e9d5896-0b7c-dbd4-e053-2a95a90ae2f63
904458pravastatin sodium 10 MG Oral TabletSCD8e9d5896-0b7c-dbd4-e053-2a95a90ae2f63
904458pravastatin sodium 10 MG Oral TabletSCD8ed7879d-988c-1a27-e053-2995a90a03613
904458pravastatin sodium 10 MG Oral TabletPSN4fad5d73-aa79-58f2-e063-6294a90af4aa1
904458pravastatin sodium 10 MG Oral TabletPSN4573c42b-6d4a-e001-e063-6294a90acea11
904458pravastatin sodium 10 MG Oral TabletPSN64ccb4b5-b77e-4b23-8c74-4685287edb4b1
904467pravastatin sodium 20 MG Oral TabletPSN64ccb4b5-b77e-4b23-8c74-4685287edb4b1
904475pravastatin sodium 40 MG Oral TabletPSN64ccb4b5-b77e-4b23-8c74-4685287edb4b1
904481pravastatin sodium 80 MG Oral TabletPSN64ccb4b5-b77e-4b23-8c74-4685287edb4b1
904458pravastatin sodium 10 MG Oral TabletSCD4573c42b-6d4a-e001-e063-6294a90acea11
904458pravastatin sodium 10 MG Oral TabletSCD64ccb4b5-b77e-4b23-8c74-4685287edb4b1
904458pravastatin sodium 10 MG Oral TabletSCD4fad5d73-aa79-58f2-e063-6294a90af4aa1
904467pravastatin sodium 20 MG Oral TabletSCD64ccb4b5-b77e-4b23-8c74-4685287edb4b1
904475pravastatin sodium 40 MG Oral TabletSCD64ccb4b5-b77e-4b23-8c74-4685287edb4b1
904481pravastatin sodium 80 MG Oral TabletSCD64ccb4b5-b77e-4b23-8c74-4685287edb4b1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
60505-0168-160505016801100 TABLET in 1 BOTTLE (60505-0168-1) 100 tablet2011-07-180000-00-00NoNoCurrent
60505-0168-46050501680440000 TABLET in 1 BOTTLE (60505-0168-4) 40000 tablet2011-07-180000-00-00NoNoCurrent
60505-0168-560505016805500 TABLET in 1 BOTTLE (60505-0168-5) 500 tablet2011-07-180000-00-00NoNoCurrent
60505-0168-7605050168071000 TABLET in 1 BOTTLE (60505-0168-7) 1000 tablet2011-07-180000-00-00NoNoCurrent
60505-0168-96050501680990 TABLET in 1 BOTTLE (60505-0168-9) 90 tablet2011-07-180000-00-00NoNoCurrent