FDA.reportPublic FDA data

Pravastatin Sodium

Product NDC
10544-505
11-digit product format
105440505
Labeler code
10544
Product ID
10544-505_10673998-0ad1-3907-e054-00144ff8d46c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pravastatin Sodium
Dosage form
TABLET
Route
ORAL
Labeler
Blenheim Pharmacal, Inc.
Application
ANDA077987
Marketing category
ANDA
Marketing start
2012-02-13
Marketing end
0000-00-00
Substance
PRAVASTATIN SODIUM
Active strength
20 mg/1
Pharmacologic classes
HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
10544-505-302020-01-31C16284748780-19d75b9cf-d703-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use pravastatin sodium tablets safely and effectively. See full prescribing information for pravastatin sodium tablets. Pravastatin Sodium Tablets USP, for oral use Initial U.S. Approval: 1991

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10544-505-30Pravastatin Sodium30 in 1 BOTTLETABLET302

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
10544-505-30EA - Each10544-505eba976f3-1298-46f7-9edd-186fc354940212015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10544-505PRAVASTATIN SODIUM TABLET [BLENHEIM PHARMACAL, INC.]2Legacy NDC, 1 package rows20150303_1053fa6d-b520-3017-e054-00144ff88e88.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
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 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 TabletSCD1053fa6d-b520-3017-e054-00144ff88e882

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
10544-505-301054405053030 in 1 BOTTLEHistorical