FDA.reportPublic FDA data

PRAVASTATIN SODIUM

Product NDC
72162-1706
11-digit product format
721621706
Labeler code
72162
Product ID
72162-1706_18567e6b-ccfd-4ab7-9287-7629ea8b5ffc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PRAVASTATIN SODIUM
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA076341
Marketing category
ANDA
Marketing start
2011-07-18
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

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
72162-1706-2PRAVASTATIN SODIUM10 in 1 BOTTLETABLET10104
72162-1706-3PRAVASTATIN SODIUM30 in 1 BOTTLETABLET30104
72162-1706-9PRAVASTATIN SODIUM90 in 1 BOTTLETABLET90104

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72162-1706-3EA - Each72162-170685ebd97d-0eed-4387-999e-abee8ecad5cc12023-10-16
72162-1706-9EA - Each72162-1706f2aeb2fe-567b-48f8-87e1-ac3889916d6d12023-10-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72162-1706PRAVASTATIN SODIUM TABLET [BRYANT RANCH PREPACK]103Current NDC, 3 package rows20250303_f4b330ce-dfb0-4e4e-9f37-482458820c66.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
904458pravastatin sodium 10 MG Oral TabletPSNf4b330ce-dfb0-4e4e-9f37-482458820c66104
904458pravastatin sodium 10 MG Oral TabletSCDf4b330ce-dfb0-4e4e-9f37-482458820c66104

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72162-1706-27216217060210 TABLET in 1 BOTTLE (72162-1706-2) 10 tablet2026-03-25NoNoHistorical
72162-1706-37216217060330 TABLET in 1 BOTTLE (72162-1706-3) 30 tablet2026-03-25NoNoHistorical
72162-1706-97216217060990 TABLET in 1 BOTTLE (72162-1706-9) 90 tablet2026-03-25NoNoHistorical