FDA.reportPublic FDA data

Pravastatin sodium

Product NDC
70377-046
11-digit product format
703770046
Labeler code
70377
Product ID
70377-046_dc0074c0-e58a-3655-2a66-084168c39615
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pravastatin sodium
Dosage form
TABLET
Route
ORAL
Labeler
Biocon Pharma Inc.
Application
ANDA209869
Marketing category
ANDA
Marketing start
2021-02-01
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
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 SODIUM20 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
70377-046-11Pravastatin sodium30 in 1 BOTTLETABLET307
70377-046-12Pravastatin sodium90 in 1 BOTTLETABLET907
70377-046-14Pravastatin sodium1000 in 1 BOTTLETABLET10007

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70377-046-14EA - Each70377-046168b0f98-c549-41c7-af8e-335ef8870dd412021-08-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70377-046PRAVASTATIN SODIUM TABLET [BIOCON PHARMA INC.]6Current NDC, Legacy NDC, 3 package rows20250330_9bd4a493-1f75-e33a-53fb-4e2fbc64a1eb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
904467pravastatin sodium 20 MG Oral TabletPSN0bb2f1e8-9405-4f06-9a33-5ba06765a8e7105
904467pravastatin sodium 20 MG Oral TabletPSN2290cad1-55c3-45a0-9d50-dd149678d191105
904467pravastatin sodium 20 MG Oral TabletSCD2290cad1-55c3-45a0-9d50-dd149678d191105
904467pravastatin sodium 20 MG Oral TabletSCD0bb2f1e8-9405-4f06-9a33-5ba06765a8e7105
904467pravastatin sodium 20 MG Oral TabletPSNca7a4143-0091-4cd5-9061-cb05cc84ea4e101
904467pravastatin sodium 20 MG Oral TabletSCDca7a4143-0091-4cd5-9061-cb05cc84ea4e101
904458pravastatin sodium 10 MG Oral TabletPSN9bd4a493-1f75-e33a-53fb-4e2fbc64a1eb7
904467pravastatin sodium 20 MG Oral TabletPSN9bd4a493-1f75-e33a-53fb-4e2fbc64a1eb7
904475pravastatin sodium 40 MG Oral TabletPSN9bd4a493-1f75-e33a-53fb-4e2fbc64a1eb7
904481pravastatin sodium 80 MG Oral TabletPSN9bd4a493-1f75-e33a-53fb-4e2fbc64a1eb7
904458pravastatin sodium 10 MG Oral TabletSCD9bd4a493-1f75-e33a-53fb-4e2fbc64a1eb7
904467pravastatin sodium 20 MG Oral TabletSCD9bd4a493-1f75-e33a-53fb-4e2fbc64a1eb7
904475pravastatin sodium 40 MG Oral TabletSCD9bd4a493-1f75-e33a-53fb-4e2fbc64a1eb7
904481pravastatin sodium 80 MG Oral TabletSCD9bd4a493-1f75-e33a-53fb-4e2fbc64a1eb7
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
904467pravastatin sodium 20 MG Oral TabletPSN40aa2d36-57ce-1f48-e063-6294a90affef2
904467pravastatin sodium 20 MG Oral TabletSCD40aa2d36-57ce-1f48-e063-6294a90affef2
904467pravastatin sodium 20 MG Oral TabletPSN3b9fe7c9-791e-49a0-a005-ccf13036c3651
904467pravastatin sodium 20 MG Oral TabletPSN2f658680-939a-4212-8a5e-a44a896dd2211
904467pravastatin sodium 20 MG Oral TabletSCD3b9fe7c9-791e-49a0-a005-ccf13036c3651
904467pravastatin sodium 20 MG Oral TabletSCD2f658680-939a-4212-8a5e-a44a896dd2211

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70377-046-117037700461130 TABLET in 1 BOTTLE (70377-046-11) 30 tablet2021-02-010000-00-00NoNoCurrent
70377-046-127037700461290 TABLET in 1 BOTTLE (70377-046-12) 90 tablet2021-02-010000-00-00NoNoCurrent
70377-046-14703770046141000 TABLET in 1 BOTTLE (70377-046-14) 1000 tablet2021-02-010000-00-00NoNoCurrent