Pravastatin sodium

Product NDC
55111-231
11-digit product format
551110231
Labeler code
55111
Product ID
55111-231_5f4e21ff-4bcc-df0d-a629-ba190d95edc0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pravastatin sodium
Dosage form
TABLET
Route
ORAL
Labeler
Dr.Reddy's Laboratories Limited
Application
ANDA076714
Marketing category
ANDA
Marketing start
2009-12-31
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
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 SODIUM40 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii3M8608UQ61
Rxcui904458, 904467, 904475, 904481

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
55111-231-01Pravastatin sodium100 in 1 BOTTLETABLET1007
55111-231-05Pravastatin sodium500 in 1 BOTTLETABLET5007
55111-231-30Pravastatin sodium30 in 1 BOTTLETABLET307
55111-231-90Pravastatin sodium90 in 1 BOTTLETABLET907

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55111-231-05EA - Each55111-231f60c0c69-9d06-462c-9d2b-670a092f4ca412012-07-24
55111-231-90EA - Each55111-231a79ed0a4-333f-4286-a38a-5d27ea846fea12012-07-24

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55111-231PRAVASTATIN SODIUM TABLET [DR.REDDY'S LABORATORIES LIMITED]7Current NDC, Legacy NDC, 4 package rows20190103_99cc0546-bb2d-751e-edfd-1c15a1182e0c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
904458pravastatin sodium 10 MG Oral TabletPSN99cc0546-bb2d-751e-edfd-1c15a1182e0c7
904467pravastatin sodium 20 MG Oral TabletPSN99cc0546-bb2d-751e-edfd-1c15a1182e0c7
904475pravastatin sodium 40 MG Oral TabletPSN99cc0546-bb2d-751e-edfd-1c15a1182e0c7
904481pravastatin sodium 80 MG Oral TabletPSN99cc0546-bb2d-751e-edfd-1c15a1182e0c7
904458pravastatin sodium 10 MG Oral TabletSCD99cc0546-bb2d-751e-edfd-1c15a1182e0c7
904467pravastatin sodium 20 MG Oral TabletSCD99cc0546-bb2d-751e-edfd-1c15a1182e0c7
904475pravastatin sodium 40 MG Oral TabletSCD99cc0546-bb2d-751e-edfd-1c15a1182e0c7
904481pravastatin sodium 80 MG Oral TabletSCD99cc0546-bb2d-751e-edfd-1c15a1182e0c7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55111-231-0155111023101100 TABLET in 1 BOTTLE (55111-231-01) 100 tablet2009-12-310000-00-00NoNoCurrent
55111-231-0555111023105500 TABLET in 1 BOTTLE (55111-231-05) 500 tablet2009-12-310000-00-00NoNoCurrent
55111-231-305511102313030 TABLET in 1 BOTTLE (55111-231-30) 30 tablet2009-12-310000-00-00NoNoCurrent
55111-231-905511102319090 TABLET in 1 BOTTLE (55111-231-90) 90 tablet2009-12-310000-00-00NoNoCurrent