FDA.reportPublic FDA data

PRAVASTATIN SODIUM

Product NDC
63629-7508
11-digit product format
636297508
Labeler code
63629
Product ID
63629-7508_027eb780-1ddd-4ba5-9226-cb88bbb4f45d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PRAVASTATIN SODIUM
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA076341
Marketing category
ANDA
Marketing start
2011-07-18
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
36361c23-a766-1581-d616-2080c781a50cProduct name520190314

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63629-7508-1PRAVASTATIN SODIUM30 in 1 BOTTLETABLET3013
63629-7508-2PRAVASTATIN SODIUM90 in 1 BOTTLETABLET9013
63629-7508-3PRAVASTATIN SODIUM58 in 1 BOTTLETABLET5813
63629-7508-4PRAVASTATIN SODIUM88 in 1 BOTTLETABLET8813
63629-7508-5PRAVASTATIN SODIUM10 in 1 BOTTLETABLET1013

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-7508-1EA - Each63629-750878ff405a-08aa-4d78-bba6-91b55ae6853a12020-09-14
63629-7508-2EA - Each63629-750836eb84fd-9d06-4eca-a4c9-dff86d04ccd412020-09-14
63629-7508-3EA - Each63629-7508b61fe47b-db8a-4fe3-ae98-31209b039f1912020-09-14
63629-7508-4EA - Each63629-750836f9ff98-1e2d-4025-9fb6-f88455b3f95c12020-09-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-7508PRAVASTATIN SODIUM TABLET [BRYANT RANCH PREPACK]12Current NDC, Legacy NDC, 5 package rows20250221_abcfc343-7ac9-4fce-b368-fd05cf14b0e2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
904481pravastatin sodium 80 MG Oral TabletPSNabcfc343-7ac9-4fce-b368-fd05cf14b0e213
904481pravastatin sodium 80 MG Oral TabletSCDabcfc343-7ac9-4fce-b368-fd05cf14b0e213

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-7508-16362975080130 TABLET in 1 BOTTLE (63629-7508-1) 30 tablet2019-01-080000-00-00NoNoCurrent
63629-7508-26362975080290 TABLET in 1 BOTTLE (63629-7508-2) 90 tablet2018-01-190000-00-00NoNoCurrent
63629-7508-36362975080358 TABLET in 1 BOTTLE (63629-7508-3) 58 tablet2021-03-190000-00-00NoNoCurrent
63629-7508-46362975080488 TABLET in 1 BOTTLE (63629-7508-4) 88 tablet2021-03-260000-00-00NoNoCurrent
63629-7508-56362975080510 TABLET in 1 BOTTLE (63629-7508-5) 10 tablet2025-01-240000-00-00NoNoCurrent