FDA.reportPublic FDA data

PRAVASTATIN SODIUM

Product NDC
63629-9165
11-digit product format
636299165
Labeler code
63629
Product ID
63629-9165_89f10602-4be6-4d81-94bd-268f5f5467b8
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
80 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 SODIUM80 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii3M8608UQ61
Rxcui904481

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
63629-9165-1PRAVASTATIN SODIUM30 in 1 BOTTLETABLET30105
63629-9165-2PRAVASTATIN SODIUM60 in 1 BOTTLETABLET60105

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-9165-1EA - Each63629-916535f8ac53-6eea-4e4d-bf9e-e0e96eb3e23912022-03-09
63629-9165-2EA - Each63629-9165297e4f17-936a-4cf5-81e6-49eb44a2f14212022-03-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-9165PRAVASTATIN SODIUM TABLET [BRYANT RANCH PREPACK]105Current NDC, Legacy NDC, 2 package rows20240816_01beb7e2-ba01-4f2f-8554-4a8ec0941c9f.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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-9165-16362991650130 TABLET in 1 BOTTLE (63629-9165-1) 30 tablet2022-02-040000-00-00NoNoCurrent
63629-9165-26362991650260 TABLET in 1 BOTTLE (63629-9165-2) 60 tablet2022-02-040000-00-00NoNoCurrent