FDA.reportPublic FDA data

PRAVASTATIN SODIUM

Product NDC
60687-897
11-digit product format
606870897
Labeler code
60687
Product ID
60687-897_4600582d-4c2e-b8ce-e063-6394a90ace45
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PRAVASTATIN SODIUM
Dosage form
TABLET
Route
ORAL
Labeler
American Health Packaging
Application
ANDA077987
Marketing category
ANDA
Marketing start
2025-03-02
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
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 SODIUM20 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii3M8608UQ61
Rxcui904458, 904467, 904475

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
60687-897-01PRAVASTATIN SODIUM100 in 1 CARTONTABLET1002
60687-897-11PRAVASTATIN SODIUM1 in 1 BLISTER PACKTABLET12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60687-897-01EA - Each60687-89755964195-be5c-43b0-b4f0-86953ab0721912025-03-04
60687-897-11EA - Each60687-897fcbe485f-95d8-44e3-ab72-b41d94fcfc4c12025-03-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60687-897PRAVASTATIN SODIUM TABLET [AMERICAN HEALTH PACKAGING]1Current NDC, 2 package rows20250303_97f826f0-b5c5-410c-b1f0-523873981e8d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
904458pravastatin sodium 10 MG Oral TabletPSN97f826f0-b5c5-410c-b1f0-523873981e8d2
904467pravastatin sodium 20 MG Oral TabletPSN97f826f0-b5c5-410c-b1f0-523873981e8d2
904475pravastatin sodium 40 MG Oral TabletPSN97f826f0-b5c5-410c-b1f0-523873981e8d2
904458pravastatin sodium 10 MG Oral TabletSCD97f826f0-b5c5-410c-b1f0-523873981e8d2
904467pravastatin sodium 20 MG Oral TabletSCD97f826f0-b5c5-410c-b1f0-523873981e8d2
904475pravastatin sodium 40 MG Oral TabletSCD97f826f0-b5c5-410c-b1f0-523873981e8d2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
60687-897-0160687089701100 BLISTER PACK in 1 CARTON (60687-897-01) / 1 TABLET in 1 BLISTER PACK (60687-897-11) 100 blister pack2025-03-02NoNoHistorical
60687-897-11606870897111 in 1 BLISTER PACKHistorical