FDA.reportPublic FDA data

Pravastatin Sodium

Product NDC
68462-197
11-digit product format
684620197
Labeler code
68462
Product ID
68462-197_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
2007-05-11
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
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 SODIUM40 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
68462-197-05Pravastatin Sodium500 in 1 BOTTLETABLET50011
68462-197-90Pravastatin Sodium90 in 1 BOTTLETABLET9011

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68462-197-05EA - Each68462-19792250b9a-9865-4789-adba-a8e88306460a12012-07-24
68462-197-90EA - Each68462-197189fda54-12d3-4b04-946b-b81e51d7784e12012-07-24

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 [BLENHEIM PHARMACAL, INC.]2
PRAVASTATINACTIVE MOIETYKXO2KT9N0GPRAVASTATIN SODIUM TABLET [BLENHEIM PHARMACAL, INC.]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UPRAVASTATIN SODIUM TABLET [BLENHEIM PHARMACAL, INC.]2
CROSPOVIDONEINACTIVE INGREDIENT68401960MKPRAVASTATIN SODIUM TABLET [BLENHEIM PHARMACAL, INC.]2
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GPRAVASTATIN SODIUM TABLET [BLENHEIM PHARMACAL, INC.]2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDPRAVASTATIN SODIUM TABLET [BLENHEIM PHARMACAL, INC.]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOPRAVASTATIN SODIUM TABLET [BLENHEIM PHARMACAL, INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PRAVASTATIN SODIUM TABLET [BLENHEIM PHARMACAL, INC.]2
MANNITOLINACTIVE INGREDIENT3OWL53L36APRAVASTATIN SODIUM TABLET [BLENHEIM PHARMACAL, INC.]2
MEGLUMINEINACTIVE INGREDIENT6HG8UB2MUYPRAVASTATIN SODIUM TABLET [BLENHEIM PHARMACAL, INC.]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4PRAVASTATIN SODIUM TABLET [BLENHEIM PHARMACAL, INC.]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJPRAVASTATIN SODIUM TABLET [BLENHEIM PHARMACAL, INC.]2
PRAVASTATIN SODIUMACTIVE INGREDIENT3M8608UQ61PRAVASTATIN SODIUM TABLET [REBEL DISTRIBUTORS CORP]1
PRAVASTATINACTIVE MOIETYKXO2KT9N0GPRAVASTATIN SODIUM TABLET [REBEL DISTRIBUTORS CORP]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UPRAVASTATIN SODIUM TABLET [REBEL DISTRIBUTORS CORP]1
CROSPOVIDONEINACTIVE INGREDIENT68401960MKPRAVASTATIN SODIUM TABLET [REBEL DISTRIBUTORS CORP]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GPRAVASTATIN SODIUM TABLET [REBEL DISTRIBUTORS CORP]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDPRAVASTATIN SODIUM TABLET [REBEL DISTRIBUTORS CORP]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOPRAVASTATIN SODIUM TABLET [REBEL DISTRIBUTORS CORP]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PRAVASTATIN SODIUM TABLET [REBEL DISTRIBUTORS CORP]1
MANNITOLINACTIVE INGREDIENT3OWL53L36APRAVASTATIN SODIUM TABLET [REBEL DISTRIBUTORS CORP]1
MEGLUMINEINACTIVE INGREDIENT6HG8UB2MUYPRAVASTATIN SODIUM TABLET [REBEL DISTRIBUTORS CORP]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4PRAVASTATIN SODIUM TABLET [REBEL DISTRIBUTORS CORP]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJPRAVASTATIN SODIUM TABLET [REBEL DISTRIBUTORS CORP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68462-197PRAVASTATIN 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 TabletPSNbdf02140-3647-498e-ba0a-f4ca920b4e9015
904475pravastatin sodium 40 MG Oral TabletPSNbdf02140-3647-498e-ba0a-f4ca920b4e9015
904458pravastatin sodium 10 MG Oral TabletSCDbdf02140-3647-498e-ba0a-f4ca920b4e9015
904475pravastatin sodium 40 MG Oral TabletSCDbdf02140-3647-498e-ba0a-f4ca920b4e9015
904458pravastatin sodium 10 MG Oral TabletPSN056475c8-59c2-469c-9175-7162065726f514
904467pravastatin sodium 20 MG Oral TabletPSN056475c8-59c2-469c-9175-7162065726f514
904475pravastatin sodium 40 MG Oral TabletPSN056475c8-59c2-469c-9175-7162065726f514
904458pravastatin sodium 10 MG Oral TabletSCD056475c8-59c2-469c-9175-7162065726f514
904467pravastatin sodium 20 MG Oral TabletSCD056475c8-59c2-469c-9175-7162065726f514
904475pravastatin sodium 40 MG Oral TabletSCD056475c8-59c2-469c-9175-7162065726f514
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 TabletPSN88e3b5b1-8379-492b-8902-af77f87ad99511
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
904475pravastatin sodium 40 MG Oral TabletSCD88e3b5b1-8379-492b-8902-af77f87ad99511
904481pravastatin sodium 80 MG Oral TabletSCD6ca01de3-a0f9-4cfb-b36a-723c7c42e2a411
904475pravastatin sodium 40 MG Oral TabletPSNdb0e9c21-dc25-629a-e053-2a95a90a5ac34
904475pravastatin sodium 40 MG Oral TabletSCDdb0e9c21-dc25-629a-e053-2a95a90a5ac34
904458pravastatin sodium 10 MG Oral TabletPSN1053fa6d-b520-3017-e054-00144ff88e882
904467pravastatin sodium 20 MG Oral TabletPSN1053fa6d-b520-3017-e054-00144ff88e882
904475pravastatin sodium 40 MG Oral TabletPSN465dc828-966e-4bb4-b935-ef26583dd4e62
904475pravastatin sodium 40 MG Oral TabletPSN1053fa6d-b520-3017-e054-00144ff88e882
904458pravastatin sodium 10 MG Oral TabletSCD1053fa6d-b520-3017-e054-00144ff88e882
904467pravastatin sodium 20 MG Oral TabletSCD1053fa6d-b520-3017-e054-00144ff88e882
904475pravastatin sodium 40 MG Oral TabletSCD465dc828-966e-4bb4-b935-ef26583dd4e62
904475pravastatin sodium 40 MG Oral TabletSCD1053fa6d-b520-3017-e054-00144ff88e882
904475pravastatin sodium 40 MG Oral TabletPSN44a07041-456a-4b0b-9a8a-9e1715327d331
904475pravastatin sodium 40 MG Oral TabletPSNbe35f51a-786a-22cc-e053-2995a90a6aad1
904475pravastatin sodium 40 MG Oral TabletSCD44a07041-456a-4b0b-9a8a-9e1715327d331
904475pravastatin sodium 40 MG Oral TabletSCDbe35f51a-786a-22cc-e053-2995a90a6aad1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68462-197-0568462019705500 TABLET in 1 BOTTLE (68462-197-05) 500 tablet2007-05-110000-00-00NoNoCurrent
68462-197-906846201979090 TABLET in 1 BOTTLE (68462-197-90) 90 tablet2007-05-110000-00-00NoNoCurrent