FDA.reportPublic FDA data

PRAVASTATIN SODIUM

Product NDC
71610-884
11-digit product format
716100884
Labeler code
71610
Product ID
71610-884_308dc3a4-51ba-ebd0-e063-6294a90acb99
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PRAVASTATIN SODIUM
Dosage form
TABLET
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA209869
Marketing category
ANDA
Marketing start
2018-04-13
Substance
PRAVASTATIN SODIUM
Active strength
40 mg/1
Pharmacologic classes
HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
PRAVASTATIN SODIUM
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PRAVASTATIN SODIUM40 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii3M8608UQ61
Rxcui904475

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71610-884-45PRAVASTATIN SODIUM45 in 1 BOTTLETABLET451
71610-884-53PRAVASTATIN SODIUM60 in 1 BOTTLETABLET601
71610-884-60PRAVASTATIN SODIUM90 in 1 BOTTLETABLET901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71610-884-45EA - Each71610-88433e7b509-6962-4929-97ca-2b0cd18091d012025-06-13
71610-884-53EA - Each71610-884224edb9d-6b28-4cec-b04c-e5860627f95512025-06-13
71610-884-60EA - Each71610-884731eba68-54be-49ba-be03-7aee479ca6fc12025-06-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71610-884PRAVASTATIN SODIUM TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC ]1Current NDC, 3 package rows20250321_308db0cc-0deb-99b6-e063-6394a90a9b74.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
904475pravastatin sodium 40 MG Oral TabletPSN308db0cc-0deb-99b6-e063-6394a90a9b741
904475pravastatin sodium 40 MG Oral TabletSCD308db0cc-0deb-99b6-e063-6394a90a9b741

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71610-884-457161008844545 TABLET in 1 BOTTLE (71610-884-45) 45 tablet2025-03-13NoNoHistorical
71610-884-537161008845360 TABLET in 1 BOTTLE (71610-884-53) 60 tablet2025-03-13NoNoHistorical
71610-884-607161008846090 TABLET in 1 BOTTLE (71610-884-60) 90 tablet2025-03-13NoNoHistorical