FDA.reportPublic FDA data

Pravastatin sodium

Product NDC
51407-887
11-digit product format
514070887
Labeler code
51407
Product ID
51407-887_4fffe2bf-0a75-d9a0-e063-6294a90a958f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pravastatin sodium
Dosage form
TABLET
Route
ORAL
Labeler
Golden State Medical Supply, Inc.
Application
ANDA209869
Marketing category
ANDA
Marketing start
2018-04-13
Substance
PRAVASTATIN SODIUM
Active strength
10 mg/1
Pharmacologic classes
HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Pravastatin sodium
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PRAVASTATIN SODIUM10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii3M8608UQ61
Rxcui904458, 904467, 904475, 904481

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
51407-887-10Pravastatin sodium1000 in 1 BOTTLETABLET10003
51407-887-90Pravastatin sodium90 in 1 BOTTLETABLET903

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51407-887-10EA - Each51407-887f4824c6f-c079-4950-bbad-c683faf91f4312024-12-10
51407-887-90EA - Each51407-88738c0e1be-1d55-402a-87ce-40266a7c687812024-12-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51407-887PRAVASTATIN SODIUM TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]2Current NDC, 2 package rows20250424_25b7276e-a69f-af63-e063-6394a90aecf2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
904458pravastatin sodium 10 MG Oral TabletPSN25b7276e-a69f-af63-e063-6394a90aecf23
904467pravastatin sodium 20 MG Oral TabletPSN25b7276e-a69f-af63-e063-6394a90aecf23
904475pravastatin sodium 40 MG Oral TabletPSN25b7276e-a69f-af63-e063-6394a90aecf23
904481pravastatin sodium 80 MG Oral TabletPSN25b7276e-a69f-af63-e063-6394a90aecf23
904458pravastatin sodium 10 MG Oral TabletSCD25b7276e-a69f-af63-e063-6394a90aecf23
904467pravastatin sodium 20 MG Oral TabletSCD25b7276e-a69f-af63-e063-6394a90aecf23
904475pravastatin sodium 40 MG Oral TabletSCD25b7276e-a69f-af63-e063-6394a90aecf23
904481pravastatin sodium 80 MG Oral TabletSCD25b7276e-a69f-af63-e063-6394a90aecf23

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
51407-887-10514070887101000 TABLET in 1 BOTTLE (51407-887-10) 1000 tablet2024-10-28NoNoHistorical
51407-887-905140708879090 TABLET in 1 BOTTLE (51407-887-90) 90 tablet2024-10-28NoNoHistorical