FDA.reportPublic FDA data

PRAVASTATIN SODIUM

Product NDC
60505-0169
11-digit product format
605050169
Labeler code
60505
Product ID
60505-0169_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
20 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 SODIUM20 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
60505-0169-1PRAVASTATIN SODIUM100 in 1 BOTTLETABLET10018
60505-0169-2PRAVASTATIN SODIUM20000 in 1 BOTTLETABLET2000018
60505-0169-5PRAVASTATIN SODIUM500 in 1 BOTTLETABLET50018
60505-0169-7PRAVASTATIN SODIUM1000 in 1 BOTTLETABLET100018
60505-0169-9PRAVASTATIN SODIUM90 in 1 BOTTLETABLET9018

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60505-0169-7EA - Each60505-016933a35503-01a8-44cd-bfbf-616d4d65b6bb12012-07-24
60505-0169-9EA - Each60505-016938fd2279-95e2-4fa3-b78e-b58f41bef58512012-07-24

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
PRAVASTATIN SODIUMACTIVE INGREDIENT3M8608UQ61PRAVASTATIN SODIUM TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
pravastatinACTIVE MOIETYKXO2KT9N0GPRAVASTATIN SODIUM TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]1
PRAVASTATINACTIVE MOIETYKXO2KT9N0GPRAVASTATIN SODIUM TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61UPRAVASTATIN SODIUM TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UPRAVASTATIN SODIUM TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
croscarmellose sodiumINACTIVE INGREDIENTM28OL1HH48PRAVASTATIN SODIUM TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]1
CROSPOVIDONEINACTIVE INGREDIENT68401960MKPRAVASTATIN SODIUM TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GPRAVASTATIN SODIUM TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDPRAVASTATIN SODIUM TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]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
HYPROMELLOSEINACTIVE INGREDIENT3NXW29V3WOPRAVASTATIN SODIUM TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
lactose monohydrateINACTIVE INGREDIENTEWQ57Q8I5XPRAVASTATIN SODIUM TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PRAVASTATIN SODIUM TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
magnesium stearateINACTIVE INGREDIENT70097M6I30PRAVASTATIN SODIUM TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]1
MANNITOLINACTIVE INGREDIENT3OWL53L36APRAVASTATIN SODIUM TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
MEGLUMINEINACTIVE INGREDIENT6HG8UB2MUYPRAVASTATIN SODIUM TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4PRAVASTATIN SODIUM TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJPRAVASTATIN SODIUM TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60505-0169PRAVASTATIN 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
904467pravastatin sodium 20 MG Oral TabletPSN8d1bf7a5-bf11-47e3-afca-dcc13f2d3068104
904467pravastatin sodium 20 MG Oral TabletSCD8d1bf7a5-bf11-47e3-afca-dcc13f2d3068104
904467pravastatin sodium 20 MG Oral TabletPSN03e27551-b3bf-47dd-b3ec-cd9a66ace3c4100
904467pravastatin sodium 20 MG Oral TabletSCD03e27551-b3bf-47dd-b3ec-cd9a66ace3c4100
904467pravastatin sodium 20 MG Oral TabletPSN93b0e546-9e0f-40d1-9b1e-082bf16400a427
904475pravastatin sodium 40 MG Oral TabletPSN93b0e546-9e0f-40d1-9b1e-082bf16400a427
904467pravastatin sodium 20 MG Oral TabletSCD93b0e546-9e0f-40d1-9b1e-082bf16400a427
904475pravastatin sodium 40 MG Oral TabletSCD93b0e546-9e0f-40d1-9b1e-082bf16400a427
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 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
904467pravastatin sodium 20 MG Oral TabletPSNc5f611aa-9974-422e-a353-5d834a33937c17
904467pravastatin sodium 20 MG Oral TabletSCDc5f611aa-9974-422e-a353-5d834a33937c17
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
904467pravastatin sodium 20 MG Oral TabletPSNe4dbaa72-7b3e-4aef-983b-90efb2b343cd13
904467pravastatin sodium 20 MG Oral TabletSCDe4dbaa72-7b3e-4aef-983b-90efb2b343cd13
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 TabletPSNfd76794d-de33-4886-875c-fa05b2639f845
904467pravastatin sodium 20 MG Oral TabletPSN97178675-3691-2d93-e053-2995a90aa5c15
904467pravastatin sodium 20 MG Oral TabletPSN4d2b4607-0a46-4b58-9247-dc448ce258ec5
904467pravastatin sodium 20 MG Oral TabletPSN54228087-7ab0-5561-e054-00144ff8d46c5
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
904467pravastatin sodium 20 MG Oral TabletSCDfd76794d-de33-4886-875c-fa05b2639f845
904467pravastatin sodium 20 MG Oral TabletSCD4d2b4607-0a46-4b58-9247-dc448ce258ec5
904467pravastatin sodium 20 MG Oral TabletSCD54228087-7ab0-5561-e054-00144ff8d46c5
904475pravastatin sodium 40 MG Oral TabletSCD97178675-3691-2d93-e053-2995a90aa5c15
904481pravastatin sodium 80 MG Oral TabletSCD97178675-3691-2d93-e053-2995a90aa5c15
904467pravastatin sodium 20 MG Oral TabletPSN6d42bd30-1f09-49f4-9ec8-31366df1b4b44
904467pravastatin sodium 20 MG Oral TabletSCD6d42bd30-1f09-49f4-9ec8-31366df1b4b44
904458pravastatin sodium 10 MG Oral TabletPSN64ccb4b5-b77e-4b23-8c74-4685287edb4b1
904467pravastatin sodium 20 MG Oral TabletPSNe4e9610a-765b-4237-a598-0f4b27a4553e1
904467pravastatin sodium 20 MG Oral TabletPSN64ccb4b5-b77e-4b23-8c74-4685287edb4b1
904475pravastatin sodium 40 MG Oral TabletPSNe4e9610a-765b-4237-a598-0f4b27a4553e1
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 TabletSCD64ccb4b5-b77e-4b23-8c74-4685287edb4b1
904467pravastatin sodium 20 MG Oral TabletSCD64ccb4b5-b77e-4b23-8c74-4685287edb4b1
904467pravastatin sodium 20 MG Oral TabletSCDe4e9610a-765b-4237-a598-0f4b27a4553e1
904475pravastatin sodium 40 MG Oral TabletSCD64ccb4b5-b77e-4b23-8c74-4685287edb4b1
904475pravastatin sodium 40 MG Oral TabletSCDe4e9610a-765b-4237-a598-0f4b27a4553e1
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
60505-0169-160505016901100 TABLET in 1 BOTTLE (60505-0169-1) 100 tablet2011-07-180000-00-00NoNoCurrent
60505-0169-26050501690220000 TABLET in 1 BOTTLE (60505-0169-2) 20000 tablet2011-07-180000-00-00NoNoCurrent
60505-0169-560505016905500 TABLET in 1 BOTTLE (60505-0169-5) 500 tablet2011-07-180000-00-00NoNoCurrent
60505-0169-7605050169071000 TABLET in 1 BOTTLE (60505-0169-7) 1000 tablet2011-07-180000-00-00NoNoCurrent
60505-0169-96050501690990 TABLET in 1 BOTTLE (60505-0169-9) 90 tablet2011-07-180000-00-00NoNoCurrent