FDA.reportPublic FDA data

PRAVASTATIN SODIUM

Product NDC
60505-1323
11-digit product format
605051323
Labeler code
60505
Product ID
60505-1323_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
80 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 SODIUM80 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
60505-1323-1PRAVASTATIN SODIUM100 in 1 BOTTLETABLET10018
60505-1323-5PRAVASTATIN SODIUM500 in 1 BOTTLETABLET50018
60505-1323-7PRAVASTATIN SODIUM1000 in 1 BOTTLETABLET100018
60505-1323-8PRAVASTATIN SODIUM5000 in 1 BOTTLETABLET500018
60505-1323-9PRAVASTATIN SODIUM90 in 1 BOTTLETABLET9018

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60505-1323-5EA - Each60505-1323a7fe643d-d6c9-4bd9-b52d-78458044b90d12012-07-24
60505-1323-9EA - Each60505-132360cf2245-2f14-4bf4-b74e-861a3133085812012-07-24

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60505-1323PRAVASTATIN 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
904481pravastatin sodium 80 MG Oral TabletPSN97123f09-b5ad-45c2-8bb7-f50566b56b08106
904481pravastatin sodium 80 MG Oral TabletSCD97123f09-b5ad-45c2-8bb7-f50566b56b08106
904481pravastatin sodium 80 MG Oral TabletPSNc0b1b483-1a19-4966-89b1-118ec660f203104
904481pravastatin sodium 80 MG Oral TabletSCDc0b1b483-1a19-4966-89b1-118ec660f203104
904481pravastatin sodium 80 MG Oral TabletPSN7b4ef7a8-47e5-428f-91de-7307dcbb916729
904481pravastatin sodium 80 MG Oral TabletSCD7b4ef7a8-47e5-428f-91de-7307dcbb916729
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
904481pravastatin sodium 80 MG Oral TabletPSNabcfc343-7ac9-4fce-b368-fd05cf14b0e213
904481pravastatin sodium 80 MG Oral TabletSCDabcfc343-7ac9-4fce-b368-fd05cf14b0e213
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
904481pravastatin sodium 80 MG Oral TabletPSNebd794ba-90c3-4d81-9c45-4aa9d94543594
904481pravastatin sodium 80 MG Oral TabletPSNdf75b04e-3e85-9705-e053-2995a90af83f4
904481pravastatin sodium 80 MG Oral TabletSCDdf75b04e-3e85-9705-e053-2995a90af83f4
904481pravastatin sodium 80 MG Oral TabletSCDebd794ba-90c3-4d81-9c45-4aa9d94543594
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 TabletPSNce61f570-2564-429b-8775-157e8e32d3781
904481pravastatin sodium 80 MG Oral TabletPSN66589077-5fae-4116-b82b-961de65dd8051
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
904475pravastatin sodium 40 MG Oral TabletSCD64ccb4b5-b77e-4b23-8c74-4685287edb4b1
904481pravastatin sodium 80 MG Oral TabletSCDce61f570-2564-429b-8775-157e8e32d3781
904481pravastatin sodium 80 MG Oral TabletSCD66589077-5fae-4116-b82b-961de65dd8051
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
60505-1323-160505132301100 TABLET in 1 BOTTLE (60505-1323-1) 100 tablet2011-07-180000-00-00NoNoCurrent
60505-1323-560505132305500 TABLET in 1 BOTTLE (60505-1323-5) 500 tablet2011-07-180000-00-00NoNoCurrent
60505-1323-7605051323071000 TABLET in 1 BOTTLE (60505-1323-7) 1000 tablet2011-07-180000-00-00NoNoCurrent
60505-1323-8605051323085000 TABLET in 1 BOTTLE (60505-1323-8) 5000 tablet2011-07-180000-00-00NoNoCurrent
60505-1323-96050513230990 TABLET in 1 BOTTLE (60505-1323-9) 90 tablet2011-07-180000-00-00NoNoCurrent