FDA.reportPublic FDA data

PRAVASTATIN SODIUM

Product NDC
68788-7660
11-digit product format
687887660
Labeler code
68788
Product ID
68788-7660_e1e742f9-41dd-484b-acdb-7cabb84b8d6b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PRAVASTATIN SODIUM
Dosage form
TABLET
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc..
Application
ANDA076341
Marketing category
ANDA
Marketing start
2022-09-27
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
68788-7660-0PRAVASTATIN SODIUM100 in 1 BOTTLETABLET1004
68788-7660-2PRAVASTATIN SODIUM20 in 1 BOTTLETABLET204
68788-7660-3PRAVASTATIN SODIUM30 in 1 BOTTLETABLET304
68788-7660-6PRAVASTATIN SODIUM60 in 1 BOTTLETABLET604
68788-7660-8PRAVASTATIN SODIUM120 in 1 BOTTLETABLET1204
68788-7660-9PRAVASTATIN SODIUM90 in 1 BOTTLETABLET904

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-7660-2EA - Each68788-766063eee21a-d605-4482-a601-5d718f31f99912022-10-06
68788-7660-3EA - Each68788-76604e1b9414-3b36-43cb-a035-ba01faa626f812022-10-06
68788-7660-6EA - Each68788-766095e2ad77-f32d-4dc6-9aed-4f410f508fa912022-10-06
68788-7660-8EA - Each68788-7660999ca148-81f8-496d-97a8-f040ff885a4112022-10-06
68788-7660-9EA - Each68788-7660e382dd78-c206-4d13-be30-0d0c002c1fd312022-10-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-7660PRAVASTATIN SODIUM TABLET [PREFERRED PHARMACEUTICALS INC..]3Current NDC, Legacy NDC, 6 package rows20240731_ebd794ba-90c3-4d81-9c45-4aa9d9454359.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
904481pravastatin sodium 80 MG Oral TabletPSNebd794ba-90c3-4d81-9c45-4aa9d94543594
904481pravastatin sodium 80 MG Oral TabletSCDebd794ba-90c3-4d81-9c45-4aa9d94543594

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68788-7660-068788766000100 TABLET in 1 BOTTLE (68788-7660-0) 100 tablet2022-09-270000-00-00NoNoCurrent
68788-7660-26878876600220 TABLET in 1 BOTTLE (68788-7660-2) 20 tablet2022-09-270000-00-00NoNoCurrent
68788-7660-36878876600330 TABLET in 1 BOTTLE (68788-7660-3) 30 tablet2022-09-270000-00-00NoNoCurrent
68788-7660-66878876600660 TABLET in 1 BOTTLE (68788-7660-6) 60 tablet2022-09-270000-00-00NoNoCurrent
68788-7660-868788766008120 TABLET in 1 BOTTLE (68788-7660-8) 120 tablet2022-09-270000-00-00NoNoCurrent
68788-7660-96878876600990 TABLET in 1 BOTTLE (68788-7660-9) 90 tablet2022-09-270000-00-00NoNoCurrent