Pravastatin Sodium

Product NDC
21695-179
11-digit product format
216950179
Labeler code
21695
Product ID
21695-179_762daef1-2ad2-444d-958b-f0a69c8ac259
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pravastatin Sodium
Dosage form
TABLET
Route
ORAL
Labeler
Rebel Distributors Corp
Application
ANDA076939
Marketing category
ANDA
Marketing start
2006-10-23
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
36361c23-a766-1581-d616-2080c781a50cProduct name520190314

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
21695-179-302019-09-24C16284748780-1934fe258-49b3-48b1-e053-8cdaa90a720aPRAVASTATIN SODIUM TABLETS USP
21695-179-902019-09-24C16284748780-1934fe258-49b3-48b1-e053-8cdaa90a720aPRAVASTATIN SODIUM TABLETS USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21695-179-30Pravastatin Sodium30 in 1 BOTTLE, PLASTICTABLET301
21695-179-90Pravastatin Sodium90 in 1 BOTTLE, PLASTICTABLET901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
21695-179-30EA - Each21695-1793f4fe92b-dc37-4098-a27d-19789f9ca58712012-07-24
21695-179-90EA - Each21695-179f7f773ea-9407-474a-9d9f-c4c7df12d9b512012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
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
croscarmellose sodiumINACTIVE INGREDIENTM28OL1HH48PRAVASTATIN SODIUM TABLET [REBEL DISTRIBUTORS CORP]1
lactose monohydrateINACTIVE INGREDIENTEWQ57Q8I5XPRAVASTATIN SODIUM TABLET [REBEL DISTRIBUTORS CORP]1
magnesium aluminum silicateINACTIVE INGREDIENT6M3P64V0NCPRAVASTATIN SODIUM TABLET [REBEL DISTRIBUTORS CORP]1
magnesium stearateINACTIVE INGREDIENT70097M6I30PRAVASTATIN SODIUM TABLET [REBEL DISTRIBUTORS CORP]1
POVIDONE K29/32INACTIVE INGREDIENT390RMW2PEQPRAVASTATIN SODIUM TABLET [REBEL DISTRIBUTORS CORP]1
talcINACTIVE INGREDIENT7SEV7J4R1UPRAVASTATIN SODIUM TABLET [REBEL DISTRIBUTORS CORP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21695-179PRAVASTATIN SODIUM TABLET [REBEL DISTRIBUTORS CORP]1Legacy NDC, 2 package rows20101119_762daef1-2ad2-444d-958b-f0a69c8ac259.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
904458pravastatin sodium 10 MG Oral TabletPSN762daef1-2ad2-444d-958b-f0a69c8ac2591
904467pravastatin sodium 20 MG Oral TabletPSN762daef1-2ad2-444d-958b-f0a69c8ac2591
904475pravastatin sodium 40 MG Oral TabletPSN762daef1-2ad2-444d-958b-f0a69c8ac2591
904458pravastatin sodium 10 MG Oral TabletSCD762daef1-2ad2-444d-958b-f0a69c8ac2591
904467pravastatin sodium 20 MG Oral TabletSCD762daef1-2ad2-444d-958b-f0a69c8ac2591
904475pravastatin sodium 40 MG Oral TabletSCD762daef1-2ad2-444d-958b-f0a69c8ac2591

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
21695-179-302169501793030 in 1 BOTTLE, PLASTICHistorical
21695-179-902169501799090 in 1 BOTTLE, PLASTICHistorical