FDA.reportPublic FDA data

Pravastatin sodium

Product NDC
84386-031
11-digit product format
843860031
Labeler code
84386
Product ID
84386-031_cf6f7031-33b9-40d3-bc87-32f1b6af98f2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pravastatin sodium
Dosage form
TABLET
Route
ORAL
Labeler
Aurobindo Pharma Limited
Application
ANDA076056
Marketing category
ANDA
Marketing start
2025-02-27
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
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 SODIUM10 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
84386-031-90Pravastatin sodium90 in 1 BOTTLETABLET901
84386-031-99Pravastatin sodium1000 in 1 BOTTLETABLET10001

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
84386-031-90EA - Each84386-03122234a40-008a-4b27-a60b-498d164542e612025-05-14
84386-031-99EA - Each84386-03182dbe7bf-429e-4bba-ad05-c4768b84e73512025-05-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84386-031PRAVASTATIN SODIUM TABLET [AUROBINDO PHARMA LIMITED]1Current NDC, 2 package rows20250302_cf6f7031-33b9-40d3-bc87-32f1b6af98f2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
904458pravastatin sodium 10 MG Oral TabletPSNcf6f7031-33b9-40d3-bc87-32f1b6af98f21
904458pravastatin sodium 10 MG Oral TabletPSNf92e12bc-40c3-4afa-9190-2f4de11ec6b31
904467pravastatin sodium 20 MG Oral TabletPSNcf6f7031-33b9-40d3-bc87-32f1b6af98f21
904475pravastatin sodium 40 MG Oral TabletPSNcf6f7031-33b9-40d3-bc87-32f1b6af98f21
904458pravastatin sodium 10 MG Oral TabletSCDcf6f7031-33b9-40d3-bc87-32f1b6af98f21
904458pravastatin sodium 10 MG Oral TabletSCDf92e12bc-40c3-4afa-9190-2f4de11ec6b31
904467pravastatin sodium 20 MG Oral TabletSCDcf6f7031-33b9-40d3-bc87-32f1b6af98f21
904475pravastatin sodium 40 MG Oral TabletSCDcf6f7031-33b9-40d3-bc87-32f1b6af98f21

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
84386-031-908438600319090 TABLET in 1 BOTTLE (84386-031-90) 90 tablet2025-02-27NoNoCurrent
84386-031-99843860031991000 TABLET in 1 BOTTLE (84386-031-99) 1000 tablet2025-02-27NoNoCurrent