PRAVASTATIN SODIUM

Product NDC
53217-379
11-digit product format
532170379
Labeler code
53217
Product ID
53217-379_ac336e81-e459-471c-abfd-3a1c67a8725d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PRAVASTATIN SODIUM
Dosage form
TABLET
Route
ORAL
Labeler
Aidarex Pharmaceuticals LLC
Application
ANDA076341
Marketing category
ANDA
Marketing start
2018-05-15
Marketing end
0000-00-00
Substance
PRAVASTATIN SODIUM
Active strength
80 mg/1
Pharmacologic classes
HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2019-12-31
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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53217-379-90PRAVASTATIN SODIUM90 in 1 BOTTLETABLET901

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53217-379PRAVASTATIN SODIUM TABLET [AIDAREX PHARMACEUTICALS LLC]1Legacy NDC, 1 package rows20180824_66589077-5fae-4116-b82b-961de65dd805.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
904481pravastatin sodium 80 MG Oral TabletPSN66589077-5fae-4116-b82b-961de65dd8051
904481pravastatin sodium 80 MG Oral TabletSCD66589077-5fae-4116-b82b-961de65dd8051

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
53217-379-905321703799090 in 1 BOTTLEHistorical