FDA.reportPublic FDA data

Pravastatin Sodium

Product NDC
54458-926
11-digit product format
544580926
Labeler code
54458
Product ID
54458-926_795f009c-6234-48fa-a1c5-62c7a28ef757
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pravastatin Sodium
Dosage form
TABLET
Route
ORAL
Labeler
International Laboratories, LLC
Application
ANDA076056
Marketing category
ANDA
Marketing start
2009-02-09
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
No
Listing certified through
2020-12-31
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
54458-926-102021-01-29C16284748780-1ba0f9c33-4941-a910-e053-dadaa90a0b85These 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
54458-926-162021-01-29C16284748780-1ba0f9c33-4941-a910-e053-dadaa90a0b85These 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
54458-926-10Pravastatin Sodium30 in 1 BLISTER PACKTABLET3030
54458-926-16Pravastatin Sodium30 in 1 BOTTLETABLET3030

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
54458-926-10EA - Each54458-92685c37efd-09d6-46b4-aa4b-2c6408b933e712012-07-24
54458-926-16EA - Each54458-9262887c054-f8ea-42c5-bdfc-ff4d6b1844d712017-05-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PRAVASTATIN SODIUMACTIVE INGREDIENT3M8608UQ61PRAVASTATIN SODIUM TABLET [INTERNATIONAL LABORATORIES, INC.]26
PRAVASTATINACTIVE MOIETYKXO2KT9N0GPRAVASTATIN SODIUM TABLET [INTERNATIONAL LABORATORIES, INC.]26
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933PRAVASTATIN SODIUM TABLET [INTERNATIONAL LABORATORIES, INC.]26
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKPRAVASTATIN SODIUM TABLET [INTERNATIONAL LABORATORIES, INC.]26
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSINACTIVE INGREDIENTL11K75P92JPRAVASTATIN SODIUM TABLET [INTERNATIONAL LABORATORIES, INC.]26
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UPRAVASTATIN SODIUM TABLET [INTERNATIONAL LABORATORIES, INC.]26
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48PRAVASTATIN SODIUM TABLET [INTERNATIONAL LABORATORIES, INC.]26
CROSPOVIDONE (15 MPA.S AT 5%)INACTIVE INGREDIENT68401960MKPRAVASTATIN SODIUM TABLET [INTERNATIONAL LABORATORIES, INC.]26
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GPRAVASTATIN SODIUM TABLET [INTERNATIONAL LABORATORIES, INC.]26
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDPRAVASTATIN SODIUM TABLET [INTERNATIONAL LABORATORIES, INC.]26
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTPRAVASTATIN SODIUM TABLET [INTERNATIONAL LABORATORIES, INC.]26
POVIDONE K30INACTIVE INGREDIENTU725QWY32XPRAVASTATIN SODIUM TABLET [INTERNATIONAL LABORATORIES, INC.]26
SODIUM STEARYL FUMARATEINACTIVE INGREDIENT7CV7WJK4UIPRAVASTATIN SODIUM TABLET [INTERNATIONAL LABORATORIES, INC.]26

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54458-926PRAVASTATIN SODIUM TABLET [INTERNATIONAL LABORATORIES, LLC]30Legacy NDC, 2 package rows20191221_e0c167a4-d8fe-4797-ac83-4364c4c5f9bb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
904467pravastatin sodium 20 MG Oral TabletPSNe0c167a4-d8fe-4797-ac83-4364c4c5f9bb30
904475pravastatin sodium 40 MG Oral TabletPSNe0c167a4-d8fe-4797-ac83-4364c4c5f9bb30
904467pravastatin sodium 20 MG Oral TabletSCDe0c167a4-d8fe-4797-ac83-4364c4c5f9bb30
904475pravastatin sodium 40 MG Oral TabletSCDe0c167a4-d8fe-4797-ac83-4364c4c5f9bb30

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
54458-926-105445809261030 in 1 BLISTER PACKHistorical
54458-926-165445809261630 in 1 BOTTLEHistorical