FDA.reportPublic FDA data

PRAVASTATIN SODIUM

Product NDC
60505-0170
11-digit product format
605050170
Labeler code
60505
Product ID
60505-0170_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
40 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 SODIUM40 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
60505-0170-1PRAVASTATIN SODIUM100 in 1 BOTTLETABLET10018
60505-0170-5PRAVASTATIN SODIUM500 in 1 BOTTLETABLET50018
60505-0170-7PRAVASTATIN SODIUM1000 in 1 BOTTLETABLET100018
60505-0170-8PRAVASTATIN SODIUM9000 in 1 BOTTLETABLET900018
60505-0170-9PRAVASTATIN SODIUM90 in 1 BOTTLETABLET9018

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60505-0170-7EA - Each60505-0170a618bcf0-e5bd-4fdb-acbc-98854f10bd0512012-07-24
60505-0170-8EA - Each60505-017006c5348d-cb56-4b41-adef-6d8d3a4c099812012-07-24
60505-0170-9EA - Each60505-01708c2d8e74-8288-424f-be11-c0181c4c8be012012-07-24

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
PRAVASTATIN SODIUMACTIVE INGREDIENT3M8608UQ61PRAVASTATIN SODIUM TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]1
pravastatinACTIVE MOIETYKXO2KT9N0GPRAVASTATIN SODIUM TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]1
PRAVASTATINACTIVE MOIETYKXO2KT9N0GPRAVASTATIN SODIUM TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]1
PRAVASTATINACTIVE MOIETYKXO2KT9N0GPRAVASTATIN SODIUM TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UPRAVASTATIN SODIUM TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]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
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48PRAVASTATIN SODIUM TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]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 [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]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
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTPRAVASTATIN SODIUM TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]1
HYPROMELLOSEINACTIVE INGREDIENT3NXW29V3WOPRAVASTATIN SODIUM TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XPRAVASTATIN SODIUM TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]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
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PRAVASTATIN SODIUM TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]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
60505-0170PRAVASTATIN 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
904475pravastatin sodium 40 MG Oral TabletPSN12943de2-c7e9-4651-89f3-fc6cb5276676106
904475pravastatin sodium 40 MG Oral TabletSCD12943de2-c7e9-4651-89f3-fc6cb5276676106
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
904475pravastatin sodium 40 MG Oral TabletPSN5ecd9fd1-7662-412d-99c5-13c77188748c20
904475pravastatin sodium 40 MG Oral TabletSCD5ecd9fd1-7662-412d-99c5-13c77188748c20
904475pravastatin sodium 40 MG Oral TabletPSN8dbdc80d-9d8c-4e22-9108-d87a77e07a6b19
904475pravastatin sodium 40 MG Oral TabletSCD8dbdc80d-9d8c-4e22-9108-d87a77e07a6b19
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
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
904475pravastatin sodium 40 MG Oral TabletPSN14390bfa-3bcb-43e1-936c-1977cb37427d13
904475pravastatin sodium 40 MG Oral TabletSCD14390bfa-3bcb-43e1-936c-1977cb37427d13
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 TabletPSNd69e8af8-dbd4-43d9-8e9a-4aed3923a17c6
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 TabletSCDd69e8af8-dbd4-43d9-8e9a-4aed3923a17c6
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 TabletPSN548bdd9f-dcc6-28c7-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
904475pravastatin sodium 40 MG Oral TabletSCD548bdd9f-dcc6-28c7-e054-00144ff8d46c5
904475pravastatin sodium 40 MG Oral TabletSCD97178675-3691-2d93-e053-2995a90aa5c15
904481pravastatin sodium 80 MG Oral TabletSCD97178675-3691-2d93-e053-2995a90aa5c15
904475pravastatin sodium 40 MG Oral TabletPSN46cdd32d-a022-4acf-ba2b-10e7877d56c64
904475pravastatin sodium 40 MG Oral TabletPSNdb5b8821-dca8-9322-e053-2a95a90abdc34
904475pravastatin sodium 40 MG Oral TabletSCD46cdd32d-a022-4acf-ba2b-10e7877d56c64
904475pravastatin sodium 40 MG Oral TabletSCDdb5b8821-dca8-9322-e053-2a95a90abdc34
904475pravastatin sodium 40 MG Oral TabletPSN2bdfb0ef-2455-4ca2-a117-ce8e26bb2dbc2
904475pravastatin sodium 40 MG Oral TabletSCD2bdfb0ef-2455-4ca2-a117-ce8e26bb2dbc2
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 TabletPSN64ccb4b5-b77e-4b23-8c74-4685287edb4b1
904475pravastatin sodium 40 MG Oral TabletPSNe4e9610a-765b-4237-a598-0f4b27a4553e1
904475pravastatin sodium 40 MG Oral TabletPSN2e5cfae8-20b8-1fea-e063-6394a90a4e171
904475pravastatin sodium 40 MG Oral TabletPSN931ddfba-7ced-4f9b-bc7c-db0f652950b81
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
904475pravastatin sodium 40 MG Oral TabletSCD2e5cfae8-20b8-1fea-e063-6394a90a4e171
904475pravastatin sodium 40 MG Oral TabletSCD931ddfba-7ced-4f9b-bc7c-db0f652950b81
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
60505-0170-160505017001100 TABLET in 1 BOTTLE (60505-0170-1) 100 tablet2011-07-180000-00-00NoNoCurrent
60505-0170-560505017005500 TABLET in 1 BOTTLE (60505-0170-5) 500 tablet2011-07-180000-00-00NoNoCurrent
60505-0170-7605050170071000 TABLET in 1 BOTTLE (60505-0170-7) 1000 tablet2011-07-180000-00-00NoNoCurrent
60505-0170-8605050170089000 TABLET in 1 BOTTLE (60505-0170-8) 9000 tablet2011-07-180000-00-00NoNoCurrent
60505-0170-96050501700990 TABLET in 1 BOTTLE (60505-0170-9) 90 tablet2011-07-180000-00-00NoNoCurrent