FDA.reportPublic FDA data

Pravastatin sodium

Product NDC
70377-045
11-digit product format
703770045
Labeler code
70377
Product ID
70377-045_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
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
70377-045-11Pravastatin sodium30 in 1 BOTTLETABLET307
70377-045-12Pravastatin sodium90 in 1 BOTTLETABLET907
70377-045-14Pravastatin sodium1000 in 1 BOTTLETABLET10007

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70377-045PRAVASTATIN 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
904458pravastatin sodium 10 MG Oral TabletPSN73633a65-93b9-46dd-8f9f-d4b5c0089040105
904458pravastatin sodium 10 MG Oral TabletSCD73633a65-93b9-46dd-8f9f-d4b5c0089040105
904458pravastatin sodium 10 MG Oral TabletPSN6bb60d07-0787-4d5f-8a8c-1224d5b02b2b104
904458pravastatin sodium 10 MG Oral TabletSCD6bb60d07-0787-4d5f-8a8c-1224d5b02b2b104
904458pravastatin sodium 10 MG Oral TabletPSN489c70a9-e574-4520-a0c0-70b7e0d87838103
904458pravastatin sodium 10 MG Oral TabletSCD489c70a9-e574-4520-a0c0-70b7e0d87838103
904458pravastatin sodium 10 MG Oral TabletPSNa7f75948-2958-44c8-b52f-5e39e80cdd1f101
904458pravastatin sodium 10 MG Oral TabletPSN7b7f5c28-78fa-4625-ad69-4291500e033d101
904458pravastatin sodium 10 MG Oral TabletSCDa7f75948-2958-44c8-b52f-5e39e80cdd1f101
904458pravastatin sodium 10 MG Oral TabletSCD7b7f5c28-78fa-4625-ad69-4291500e033d101
904458pravastatin sodium 10 MG Oral TabletPSN4ed7a4d1-1183-4d95-8311-6d3e58feafa8100
904458pravastatin sodium 10 MG Oral TabletSCD4ed7a4d1-1183-4d95-8311-6d3e58feafa8100
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70377-045-117037700451130 TABLET in 1 BOTTLE (70377-045-11) 30 tablet2021-02-010000-00-00NoNoCurrent
70377-045-127037700451290 TABLET in 1 BOTTLE (70377-045-12) 90 tablet2021-02-010000-00-00NoNoCurrent
70377-045-14703770045141000 TABLET in 1 BOTTLE (70377-045-14) 1000 tablet2021-02-010000-00-00NoNoCurrent