FDA.reportPublic FDA data

PRAVASTATIN SODIUM

Product NDC
63629-9162
11-digit product format
636299162
Labeler code
63629
Product ID
63629-9162_1d58e035-58ec-4729-80f8-fb47f544da8c
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
10 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 SODIUM10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii3M8608UQ61
Rxcui904458

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
63629-9162-1PRAVASTATIN SODIUM30 in 1 BOTTLETABLET30104
63629-9162-2PRAVASTATIN SODIUM60 in 1 BOTTLETABLET60104

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-9162-1EA - Each63629-9162457ee6db-9af1-4915-afea-a2a00c55aa0812022-03-09
63629-9162-2EA - Each63629-916272e3389f-34b9-4e2b-bbf9-1d4a2fddc2a812022-03-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-9162PRAVASTATIN SODIUM TABLET [BRYANT RANCH PREPACK]104Current NDC, Legacy NDC, 2 package rows20240901_6bb60d07-0787-4d5f-8a8c-1224d5b02b2b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
904458pravastatin sodium 10 MG Oral TabletPSN6bb60d07-0787-4d5f-8a8c-1224d5b02b2b104
904458pravastatin sodium 10 MG Oral TabletSCD6bb60d07-0787-4d5f-8a8c-1224d5b02b2b104

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-9162-16362991620130 TABLET in 1 BOTTLE (63629-9162-1) 30 tablet2022-02-040000-00-00NoNoCurrent
63629-9162-26362991620260 TABLET in 1 BOTTLE (63629-9162-2) 60 tablet2022-02-040000-00-00NoNoCurrent