FDA.reportPublic FDA data

Pravastatin sodium

Product NDC
70377-047
11-digit product format
703770047
Labeler code
70377
Product ID
70377-047_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
40 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 SODIUM40 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
70377-047-11Pravastatin sodium30 in 1 BOTTLETABLET307
70377-047-12Pravastatin sodium90 in 1 BOTTLETABLET907
70377-047-14Pravastatin sodium1000 in 1 BOTTLETABLET10007

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70377-047PRAVASTATIN 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
904475pravastatin sodium 40 MG Oral TabletPSNe358f314-9cbe-46a4-9564-6bedc7ef9d59105
904475pravastatin sodium 40 MG Oral TabletSCDe358f314-9cbe-46a4-9564-6bedc7ef9d59105
904475pravastatin sodium 40 MG Oral TabletPSN06d85243-f9df-4984-b3d3-fcd8a7c554e9104
904475pravastatin sodium 40 MG Oral TabletPSNdcf46d0c-87da-4009-b238-eb5cf287c3ed104
904475pravastatin sodium 40 MG Oral TabletSCD06d85243-f9df-4984-b3d3-fcd8a7c554e9104
904475pravastatin sodium 40 MG Oral TabletSCDdcf46d0c-87da-4009-b238-eb5cf287c3ed104
904475pravastatin sodium 40 MG Oral TabletPSN51800012-406b-4389-817f-88dd21e338d1101
904475pravastatin sodium 40 MG Oral TabletSCD51800012-406b-4389-817f-88dd21e338d1101
904475pravastatin sodium 40 MG Oral TabletPSNf074240e-ef6b-45f2-8c4d-cb5c0dbc81f1100
904475pravastatin sodium 40 MG Oral TabletPSN91c5b5c8-3379-4b84-aff7-ef6cfc65fe9f100
904475pravastatin sodium 40 MG Oral TabletSCDf074240e-ef6b-45f2-8c4d-cb5c0dbc81f1100
904475pravastatin sodium 40 MG Oral TabletSCD91c5b5c8-3379-4b84-aff7-ef6cfc65fe9f100
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
904475pravastatin sodium 40 MG Oral TabletPSN47207487-0c6d-8da3-e063-6294a90a8aee2
904475pravastatin sodium 40 MG Oral TabletSCD47207487-0c6d-8da3-e063-6294a90a8aee2
904475pravastatin sodium 40 MG Oral TabletPSN72693449-01ee-42b0-9902-5662523245791
904475pravastatin sodium 40 MG Oral TabletPSN33c141e9-76dc-4e32-9b2a-4621f32ac4bd1
904475pravastatin sodium 40 MG Oral TabletPSN3686a2df-51c4-4f1c-9d1e-d692079151441
904475pravastatin sodium 40 MG Oral TabletSCD72693449-01ee-42b0-9902-5662523245791
904475pravastatin sodium 40 MG Oral TabletSCD33c141e9-76dc-4e32-9b2a-4621f32ac4bd1
904475pravastatin sodium 40 MG Oral TabletSCD3686a2df-51c4-4f1c-9d1e-d692079151441

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70377-047-117037700471130 TABLET in 1 BOTTLE (70377-047-11) 30 tablet2021-02-010000-00-00NoNoCurrent
70377-047-127037700471290 TABLET in 1 BOTTLE (70377-047-12) 90 tablet2021-02-010000-00-00NoNoCurrent
70377-047-14703770047141000 TABLET in 1 BOTTLE (70377-047-14) 1000 tablet2021-02-010000-00-00NoNoCurrent