Pravastatin Sodium

Product NDC
43353-966
11-digit product format
433530966
Labeler code
43353
Product ID
43353-966_0d6fa0b8-bef8-42ff-8b4e-ea21b291a8e2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pravastatin Sodium
Dosage form
TABLET
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA077793
Marketing category
ANDA
Marketing start
2014-06-17
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
2022-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43353-966-45EA - Each43353-966dcb14520-2a6a-4e48-871d-4d4bdb9bf93512016-07-19
43353-966-60EA - Each43353-9665cff91e9-7aa1-4aa1-b032-2c17ad25888612021-04-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43353-966PRAVASTATIN SODIUM (PRAVASTATIN SODIUM) TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2Legacy NDC20210316_576f2e65-2bf6-4f6b-8538-50221f2d88bb.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43353-966-454335309664545 TABLET in 1 BOTTLE (43353-966-45) 45 tablet2014-09-300000-00-00NoNoCurrent
43353-966-604335309666090 TABLET in 1 BOTTLE (43353-966-60) 90 tablet2021-01-200000-00-00NoNoCurrent