FDA.reportPublic FDA data

PRAVASTATIN SODIUM

Product NDC
60687-908
11-digit product format
606870908
Labeler code
60687
Product ID
60687-908_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
Marketing end
2027-03-31
Substance
PRAVASTATIN SODIUM
Active strength
40 mg/1
Pharmacologic classes
HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
PRAVASTATIN SODIUM

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PRAVASTATIN SODIUM40 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
60687-908-01PRAVASTATIN SODIUM100 in 1 CARTONTABLET1002
60687-908-11PRAVASTATIN SODIUM1 in 1 BLISTER PACKTABLET12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60687-908-01EA - Each60687-9085302e8b8-20aa-4500-a8a6-3d5483ecb95812025-03-04
60687-908-11EA - Each60687-908c4383445-0fb6-47eb-854f-ca3e52ee6eb112025-03-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60687-908PRAVASTATIN 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 startMarketing endSampleExclude flagStatus
60687-908-0160687090801100 BLISTER PACK in 1 CARTON (60687-908-01) / 1 TABLET in 1 BLISTER PACK (60687-908-11) 100 blister pack2025-03-022027-03-31NoNoHistorical
60687-908-11606870908111 in 1 BLISTER PACKHistorical