PRAVASTATIN SODIUM

Product NDC
70934-358
11-digit product format
709340358
Labeler code
70934
Product ID
70934-358_b09c864c-5c3d-ba77-e053-2995a90a52ff
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PRAVASTATIN SODIUM
Dosage form
TABLET
Route
ORAL
Labeler
Denton Pharma, Inc. DBA Northwind Pharmaceuticals
Application
ANDA207068
Marketing category
ANDA
Marketing start
2019-05-06
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
2021-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
36361c23-a766-1581-d616-2080c781a50cProduct name520190314
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70934-358-30PRAVASTATIN SODIUM30 in 1 BOTTLE, PLASTICTABLET302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70934-358PRAVASTATIN SODIUM TABLET [DENTON PHARMA, INC. DBA NORTHWIND PHARMACEUTICALS]2Legacy NDC, 1 package rows20201224_8cf2a434-dada-a611-e053-2a95a90a7013.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
904467pravastatin sodium 20 MG Oral TabletPSN8cf2a434-dada-a611-e053-2a95a90a70132
904467pravastatin sodium 20 MG Oral TabletSCD8cf2a434-dada-a611-e053-2a95a90a70132

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70934-358-307093403583030 TABLET in 1 BOTTLE, PLASTIC (70934-358-30) 30 tablet2019-05-060000-00-00NoNoCurrent