FDA.reportPublic FDA data

Pravastatin sodium

Product NDC
70377-048
11-digit product format
703770048
Labeler code
70377
Product ID
70377-048_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
80 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 SODIUM80 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
70377-048-11Pravastatin sodium30 in 1 BOTTLETABLET307
70377-048-12Pravastatin sodium90 in 1 BOTTLETABLET907
70377-048-13Pravastatin sodium500 in 1 BOTTLETABLET5007

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70377-048-12EA - Each70377-0488bf09338-7850-42b2-8c5e-8bef2d0d037212021-08-05
70377-048-13EA - Each70377-048fedc4884-5fd5-4671-ae12-18562a8dc39512021-08-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70377-048PRAVASTATIN 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
904481pravastatin sodium 80 MG Oral TabletPSN01beb7e2-ba01-4f2f-8554-4a8ec0941c9f105
904481pravastatin sodium 80 MG Oral TabletSCD01beb7e2-ba01-4f2f-8554-4a8ec0941c9f105
904481pravastatin sodium 80 MG Oral TabletPSN80ddec55-6a18-4b87-8a07-6ae86ad62853103
904481pravastatin sodium 80 MG Oral TabletPSN70920620-37d6-4fe0-9d86-1fdffc2e6a99103
904481pravastatin sodium 80 MG Oral TabletSCD70920620-37d6-4fe0-9d86-1fdffc2e6a99103
904481pravastatin sodium 80 MG Oral TabletSCD80ddec55-6a18-4b87-8a07-6ae86ad62853103
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
70377-048-117037700481130 TABLET in 1 BOTTLE (70377-048-11) 30 tablet2021-02-010000-00-00NoNoCurrent
70377-048-127037700481290 TABLET in 1 BOTTLE (70377-048-12) 90 tablet2021-02-010000-00-00NoNoCurrent
70377-048-1370377004813500 TABLET in 1 BOTTLE (70377-048-13) 500 tablet2021-02-010000-00-00NoNoCurrent