FDA.reportPublic FDA data

Pravastatin Sodium

Product NDC
68462-198
11-digit product format
684620198
Labeler code
68462
Product ID
68462-198_a6e006b3-4256-4cbb-8ad1-b71f363430cd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pravastatin Sodium
Dosage form
TABLET
Route
ORAL
Labeler
Glenmark Pharmaceuticals Inc., USA
Application
ANDA077987
Marketing category
ANDA
Marketing start
2007-12-28
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Pravastatin Sodium
Listing expiration
2026-12-31

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
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
36361c23-a766-1581-d616-2080c781a50cProduct name520190314
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68462-198-05Pravastatin Sodium500 in 1 BOTTLETABLET50011
68462-198-90Pravastatin Sodium90 in 1 BOTTLETABLET9011

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68462-198-05EA - Each68462-1983cf4cdd1-941e-494b-9c65-52b5b407a6e512012-07-24
68462-198-90EA - Each68462-198f33174c1-7ce5-4eab-bc09-baa92f55080312012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PRAVASTATIN SODIUMACTIVE INGREDIENT3M8608UQ61PRAVASTATIN SODIUM TABLET [GLENMARK PHARMACEUTICALS INC., USA]5
PRAVASTATINACTIVE MOIETYKXO2KT9N0GPRAVASTATIN SODIUM TABLET [GLENMARK PHARMACEUTICALS INC., USA]5
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UPRAVASTATIN SODIUM TABLET [GLENMARK PHARMACEUTICALS INC., USA]5
CROSPOVIDONEINACTIVE INGREDIENT68401960MKPRAVASTATIN SODIUM TABLET [GLENMARK PHARMACEUTICALS INC., USA]5
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GPRAVASTATIN SODIUM TABLET [GLENMARK PHARMACEUTICALS INC., USA]5
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDPRAVASTATIN SODIUM TABLET [GLENMARK PHARMACEUTICALS INC., USA]5
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOPRAVASTATIN SODIUM TABLET [GLENMARK PHARMACEUTICALS INC., USA]5
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PRAVASTATIN SODIUM TABLET [GLENMARK PHARMACEUTICALS INC., USA]5
MANNITOLINACTIVE INGREDIENT3OWL53L36APRAVASTATIN SODIUM TABLET [GLENMARK PHARMACEUTICALS INC., USA]5
MEGLUMINEINACTIVE INGREDIENT6HG8UB2MUYPRAVASTATIN SODIUM TABLET [GLENMARK PHARMACEUTICALS INC., USA]5
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4PRAVASTATIN SODIUM TABLET [GLENMARK PHARMACEUTICALS INC., USA]5
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJPRAVASTATIN SODIUM TABLET [GLENMARK PHARMACEUTICALS INC., USA]5
PRAVASTATIN SODIUMACTIVE INGREDIENT3M8608UQ61PRAVASTATIN SODIUM TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
PRAVASTATINACTIVE MOIETYKXO2KT9N0GPRAVASTATIN SODIUM TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UPRAVASTATIN SODIUM TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]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
HYPROMELLOSEINACTIVE INGREDIENT3NXW29V3WOPRAVASTATIN SODIUM TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PRAVASTATIN SODIUM TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]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
68462-198PRAVASTATIN SODIUM TABLET [GLENMARK PHARMACEUTICALS INC., USA]11Current NDC, Legacy NDC, 2 package rows20220811_6ca01de3-a0f9-4cfb-b36a-723c7c42e2a4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
904458pravastatin sodium 10 MG Oral TabletPSN6ca01de3-a0f9-4cfb-b36a-723c7c42e2a411
904467pravastatin sodium 20 MG Oral TabletPSN6ca01de3-a0f9-4cfb-b36a-723c7c42e2a411
904475pravastatin sodium 40 MG Oral TabletPSN6ca01de3-a0f9-4cfb-b36a-723c7c42e2a411
904481pravastatin sodium 80 MG Oral TabletPSN6ca01de3-a0f9-4cfb-b36a-723c7c42e2a411
904458pravastatin sodium 10 MG Oral TabletSCD6ca01de3-a0f9-4cfb-b36a-723c7c42e2a411
904467pravastatin sodium 20 MG Oral TabletSCD6ca01de3-a0f9-4cfb-b36a-723c7c42e2a411
904475pravastatin sodium 40 MG Oral TabletSCD6ca01de3-a0f9-4cfb-b36a-723c7c42e2a411
904481pravastatin sodium 80 MG Oral TabletSCD6ca01de3-a0f9-4cfb-b36a-723c7c42e2a411
904481pravastatin sodium 80 MG Oral TabletPSN3a08fa97-24c3-4a4a-a0aa-26e50cbfc52d3
904481pravastatin sodium 80 MG Oral TabletSCD3a08fa97-24c3-4a4a-a0aa-26e50cbfc52d3
904458pravastatin sodium 10 MG Oral TabletPSNea2d1275-8437-4979-8199-24eb9678be941
904481pravastatin sodium 80 MG Oral TabletPSNea2d1275-8437-4979-8199-24eb9678be941
904458pravastatin sodium 10 MG Oral TabletSCDea2d1275-8437-4979-8199-24eb9678be941
904481pravastatin sodium 80 MG Oral TabletSCDea2d1275-8437-4979-8199-24eb9678be941

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68462-198-0568462019805500 TABLET in 1 BOTTLE (68462-198-05) 500 tablet2007-12-280000-00-00NoNoCurrent
68462-198-906846201989090 TABLET in 1 BOTTLE (68462-198-90) 90 tablet2007-12-280000-00-00NoNoCurrent