FDA.reportPublic FDA data

Pravastatin sodium

Product NDC
71335-2746
11-digit product format
713352746
Labeler code
71335
Product ID
71335-2746_d59deb97-1fc1-45c8-8356-3a3e6f890390
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pravastatin sodium
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
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
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
Rxcui904475

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
71335-2746-1Pravastatin sodium30 in 1 BOTTLETABLET301
71335-2746-2Pravastatin sodium60 in 1 BOTTLETABLET601
71335-2746-3Pravastatin sodium90 in 1 BOTTLETABLET901
71335-2746-4Pravastatin sodium100 in 1 BOTTLETABLET1001
71335-2746-5Pravastatin sodium10 in 1 BOTTLETABLET101

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
904475pravastatin sodium 40 MG Oral TabletPSN3686a2df-51c4-4f1c-9d1e-d692079151441
904475pravastatin sodium 40 MG Oral TabletSCD3686a2df-51c4-4f1c-9d1e-d692079151441

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71335-2746-17133527460130 TABLET in 1 BOTTLE (71335-2746-1) 30 tablet2025-10-02NoNoCurrent
71335-2746-27133527460260 TABLET in 1 BOTTLE (71335-2746-2) 60 tablet2025-10-02NoNoCurrent
71335-2746-37133527460390 TABLET in 1 BOTTLE (71335-2746-3) 90 tablet2025-10-02NoNoCurrent
71335-2746-471335274604100 TABLET in 1 BOTTLE (71335-2746-4) 100 tablet2025-10-02NoNoCurrent
71335-2746-57133527460510 TABLET in 1 BOTTLE (71335-2746-5) 10 tablet2025-10-02NoNoCurrent