FDA.reportPublic FDA data

PRAVASTATIN SODIUM

Product NDC
71610-877
11-digit product format
716100877
Labeler code
71610
Product ID
71610-877_2e5c8659-3b46-bf9f-e063-6294a90aed12
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
80 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 SODIUM80 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii3M8608UQ61
Rxcui904481

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
71610-877-30PRAVASTATIN SODIUM30 in 1 BOTTLETABLET301
71610-877-45PRAVASTATIN SODIUM45 in 1 BOTTLETABLET451
71610-877-53PRAVASTATIN SODIUM60 in 1 BOTTLETABLET601
71610-877-60PRAVASTATIN SODIUM90 in 1 BOTTLETABLET901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71610-877-30EA - Each71610-877a0c6cfdd-9c46-4043-b1f5-c5e27e0b042a12025-05-14
71610-877-45EA - Each71610-877a423178f-4edc-4185-af71-74b0c70d4c7c12025-05-14
71610-877-53EA - Each71610-877c76b0ae7-14d7-4eb9-82ee-d0f406e5934112025-05-14
71610-877-60EA - Each71610-8775ea4bbc8-c659-4272-96c5-067d8e8ed39a12025-05-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71610-877PRAVASTATIN SODIUM TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC ]1Current NDC, 4 package rows20250221_2e5c8a1c-b36f-d124-e063-6394a90a6fb5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
904481pravastatin sodium 80 MG Oral TabletPSN2e5c8a1c-b36f-d124-e063-6394a90a6fb51
904481pravastatin sodium 80 MG Oral TabletSCD2e5c8a1c-b36f-d124-e063-6394a90a6fb51

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71610-877-307161008773030 TABLET in 1 BOTTLE (71610-877-30) 30 tablet2025-02-12NoNoCurrent
71610-877-457161008774545 TABLET in 1 BOTTLE (71610-877-45) 45 tablet2025-02-12NoNoCurrent
71610-877-537161008775360 TABLET in 1 BOTTLE (71610-877-53) 60 tablet2025-02-12NoNoCurrent
71610-877-607161008776090 TABLET in 1 BOTTLE (71610-877-60) 90 tablet2025-02-12NoNoCurrent