FDA.reportPublic FDA data

Pravastatin Sodium

Product NDC
54458-927
11-digit product format
544580927
Labeler code
54458
Product ID
54458-927_6316f531-a9e0-49a9-8a6a-fa29675217cb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pravastatin Sodium
Dosage form
TABLET
Route
ORAL
Labeler
International Laboratories, LLC
Application
ANDA076056
Marketing category
ANDA
Marketing start
2013-04-26
Marketing end
0000-00-00
Substance
PRAVASTATIN SODIUM
Active strength
10 mg/1
Pharmacologic classes
HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]
NDC exclude flag
E
Listing certified through
2018-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
36361c23-a766-1581-d616-2080c781a50cProduct name520190314

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
54458-927-102020-01-31C16284748780-19d75b9d1-0645-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, for oral use Initial U.S. Approval: 1991
54458-927-122020-01-31C16284748780-19d75b9d1-0645-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, for oral use Initial U.S. Approval: 1991
54458-927-162020-01-31C16284748780-19d75b9d1-0645-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, for oral use Initial U.S. Approval: 1991

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54458-927-10Pravastatin Sodium30 in 1 BLISTER PACKTABLET3012
54458-927-12Pravastatin Sodium30 in 1 BLISTER PACKTABLET3012
54458-927-16Pravastatin Sodium30 in 1 BOTTLETABLET3012

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
54458-927-10EA - Each54458-927c0baabd7-5646-4a35-8777-e92a2e02440412012-07-24
54458-927-12EA - Each54458-927b1238415-becc-4106-8c44-3ee9e15e2e4712016-02-04
54458-927-16EA - Each54458-9273380fddf-df26-4e84-bce1-5c7d8017eeb512017-05-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PRAVASTATIN SODIUMACTIVE INGREDIENT3M8608UQ61PRAVASTATIN SODIUM TABLET [INTERNATIONAL LABS, INC.]9
PRAVASTATINACTIVE MOIETYKXO2KT9N0GPRAVASTATIN SODIUM TABLET [INTERNATIONAL LABS, INC.]9
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKPRAVASTATIN SODIUM TABLET [INTERNATIONAL LABS, INC.]9
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSINACTIVE INGREDIENTL11K75P92JPRAVASTATIN SODIUM TABLET [INTERNATIONAL LABS, INC.]9
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UPRAVASTATIN SODIUM TABLET [INTERNATIONAL LABS, INC.]9
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48PRAVASTATIN SODIUM TABLET [INTERNATIONAL LABS, INC.]9
CROSPOVIDONEINACTIVE INGREDIENT68401960MKPRAVASTATIN SODIUM TABLET [INTERNATIONAL LABS, INC.]9
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675PRAVASTATIN SODIUM TABLET [INTERNATIONAL LABS, INC.]9
POVIDONE K30INACTIVE INGREDIENTU725QWY32XPRAVASTATIN SODIUM TABLET [INTERNATIONAL LABS, INC.]9
SODIUM STEARYL FUMARATEINACTIVE INGREDIENT7CV7WJK4UIPRAVASTATIN SODIUM TABLET [INTERNATIONAL LABS, INC.]9

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54458-927PRAVASTATIN SODIUM TABLET [INTERNATIONAL LABORATORIES, LLC]12Legacy NDC, 3 package rows20170404_ad386ed4-a284-4da5-b79a-3c0f4165057a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
904458pravastatin sodium 10 MG Oral TabletPSNad386ed4-a284-4da5-b79a-3c0f4165057a12
904458pravastatin sodium 10 MG Oral TabletSCDad386ed4-a284-4da5-b79a-3c0f4165057a12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
54458-927-105445809271030 in 1 BLISTER PACKHistorical
54458-927-125445809271230 in 1 BLISTER PACKHistorical
54458-927-165445809271630 in 1 BOTTLEHistorical