FDA.reportPublic FDA data

Pravastatin Sodium

Product NDC
70518-2887
11-digit product format
705182887
Labeler code
70518
Product ID
70518-2887_4ab8510c-0de1-0008-e063-6394a90ab878
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pravastatin Sodium
Dosage form
TABLET
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA076056
Marketing category
ANDA
Marketing start
2020-09-15
Marketing end
2026-08-31
Substance
PRAVASTATIN SODIUM
Active strength
20 mg/1
Pharmacologic classes
HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Pravastatin Sodium

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PRAVASTATIN SODIUM20 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii3M8608UQ61
Rxcui904467

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
70518-2887-02022-02-08C16284748780-1d6a99b39-46f1-a426-e053-dadaa90af4c2These 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
70518-2887-02022-01-28C16284748780-1d6a99b39-46f1-a426-e053-dadaa90af4c2These 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
70518-2887-0Pravastatin Sodium90 in 1 BOTTLE, PLASTICTABLET9010
70518-2887-1Pravastatin Sodium90 in 1 BOTTLE, PLASTICTABLET9010
70518-2887-2Pravastatin Sodium30 in 1 BLISTER PACKTABLET3010

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-2887PRAVASTATIN SODIUM TABLET [REMEDYREPACK INC.]8Current NDC, Legacy NDC, 3 package rows20250406_0c4b59f1-92a8-44f8-8b4c-691f35777460.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
904467pravastatin sodium 20 MG Oral TabletPSN0c4b59f1-92a8-44f8-8b4c-691f3577746010
904467pravastatin sodium 20 MG Oral TabletSCD0c4b59f1-92a8-44f8-8b4c-691f3577746010

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-2887-07051828870090 TABLET in 1 BOTTLE, PLASTIC (70518-2887-0) 90 tablet2020-09-150000-00-00NoNoCurrent
70518-2887-17051828870190 TABLET in 1 BOTTLE, PLASTIC (70518-2887-1) 90 tablet2022-09-162026-08-31NoNoCurrent
70518-2887-27051828870230 TABLET in 1 BLISTER PACK (70518-2887-2) 30 tablet2022-11-080000-00-00NoNoCurrent