FDA.reportPublic FDA data

Pravastatin Sodium

Product NDC
54458-867
11-digit product format
544580867
Labeler code
54458
Product ID
54458-867_8b9d37a4-c138-4859-825c-9400fd3d822b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pravastatin Sodium
Dosage form
TABLET
Route
ORAL
Labeler
International Laboratories, LLC
Application
ANDA076056
Marketing category
ANDA
Marketing start
2015-05-01
Marketing end
0000-00-00
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
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
54458-867-102021-01-29C16284748780-1ba0f9c33-53c6-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
54458-867-10Pravastatin Sodium30 in 1 BLISTER PACKTABLET306

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
54458-867-10EA - Each54458-867b4435b99-dd8d-4ba6-bf52-3c4e970643ed12015-07-20

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PRAVASTATIN SODIUMACTIVE INGREDIENT3M8608UQ61PRAVASTATIN SODIUM TABLET [INTERNATIONAL LABORATORIES, INC.]2
PRAVASTATINACTIVE MOIETYKXO2KT9N0GPRAVASTATIN SODIUM TABLET [INTERNATIONAL LABORATORIES, INC.]2
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933PRAVASTATIN SODIUM TABLET [INTERNATIONAL LABORATORIES, INC.]2
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKPRAVASTATIN SODIUM TABLET [INTERNATIONAL LABORATORIES, INC.]2
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSINACTIVE INGREDIENTL11K75P92JPRAVASTATIN SODIUM TABLET [INTERNATIONAL LABORATORIES, INC.]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UPRAVASTATIN SODIUM TABLET [INTERNATIONAL LABORATORIES, INC.]2
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48PRAVASTATIN SODIUM TABLET [INTERNATIONAL LABORATORIES, INC.]2
CROSPOVIDONE (15 MPA.S AT 5%)INACTIVE INGREDIENT68401960MKPRAVASTATIN SODIUM TABLET [INTERNATIONAL LABORATORIES, INC.]2
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GPRAVASTATIN SODIUM TABLET [INTERNATIONAL LABORATORIES, INC.]2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDPRAVASTATIN SODIUM TABLET [INTERNATIONAL LABORATORIES, INC.]2
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTPRAVASTATIN SODIUM TABLET [INTERNATIONAL LABORATORIES, INC.]2
POVIDONE K30INACTIVE INGREDIENTU725QWY32XPRAVASTATIN SODIUM TABLET [INTERNATIONAL LABORATORIES, INC.]2
SODIUM STEARYL FUMARATEINACTIVE INGREDIENT7CV7WJK4UIPRAVASTATIN SODIUM TABLET [INTERNATIONAL LABORATORIES, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54458-867PRAVASTATIN SODIUM TABLET [INTERNATIONAL LABORATORIES, LLC]6Legacy NDC, 1 package rows20191219_797f30c0-3fd5-4609-bc01-beb98a04b04f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
904467pravastatin sodium 20 MG Oral TabletPSN797f30c0-3fd5-4609-bc01-beb98a04b04f6
904475pravastatin sodium 40 MG Oral TabletPSN797f30c0-3fd5-4609-bc01-beb98a04b04f6
904467pravastatin sodium 20 MG Oral TabletSCD797f30c0-3fd5-4609-bc01-beb98a04b04f6
904475pravastatin sodium 40 MG Oral TabletSCD797f30c0-3fd5-4609-bc01-beb98a04b04f6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
54458-867-105445808671030 in 1 BLISTER PACKHistorical