FDA.reportPublic FDA data

PRAVASTATIN SODIUM

Product NDC
71610-879
11-digit product format
716100879
Labeler code
71610
Product ID
71610-879_2e5cffad-a4e1-033a-e063-6294a90a00ac
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PRAVASTATIN SODIUM
Dosage form
TABLET
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA076341
Marketing category
ANDA
Marketing start
2011-07-18
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
36361c23-a766-1581-d616-2080c781a50cProduct name520190314

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71610-879-45PRAVASTATIN SODIUM45 in 1 BOTTLETABLET451
71610-879-53PRAVASTATIN SODIUM60 in 1 BOTTLETABLET601
71610-879-60PRAVASTATIN SODIUM90 in 1 BOTTLETABLET901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71610-879-45EA - Each71610-879293484ce-a8a9-4670-98ee-9eda51ce7b9012025-05-14
71610-879-53EA - Each71610-8796014b8e8-80dc-4c88-92d4-102e0778f32b12025-05-14
71610-879-60EA - Each71610-879eb0693a2-cb7f-4aeb-8236-0195567dbbb612025-05-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71610-879PRAVASTATIN SODIUM TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC ]1Current NDC, 3 package rows20250221_2e5cfae8-20b8-1fea-e063-6394a90a4e17.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
904475pravastatin sodium 40 MG Oral TabletPSN2e5cfae8-20b8-1fea-e063-6394a90a4e171
904475pravastatin sodium 40 MG Oral TabletSCD2e5cfae8-20b8-1fea-e063-6394a90a4e171

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71610-879-457161008794545 TABLET in 1 BOTTLE (71610-879-45) 45 tablet2025-02-13NoNoHistorical
71610-879-537161008795360 TABLET in 1 BOTTLE (71610-879-53) 60 tablet2025-02-13NoNoHistorical
71610-879-607161008796090 TABLET in 1 BOTTLE (71610-879-60) 90 tablet2025-02-13NoNoHistorical