Pravastatin sodium

Product NDC
68788-4049
11-digit product format
687884049
Labeler code
68788
Product ID
68788-4049_e6a3d99c-c9cc-49d9-b0f9-503770307b70
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pravastatin sodium
Dosage form
TABLET
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA076056
Marketing category
ANDA
Marketing start
2025-10-31
Substance
PRAVASTATIN SODIUM
Active strength
20 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 SODIUM20 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii3M8608UQ61
Rxcui904467

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
68788-4049-3Pravastatin sodium30 in 1 BOTTLETABLET301
68788-4049-6Pravastatin sodium60 in 1 BOTTLETABLET601
68788-4049-9Pravastatin sodium90 in 1 BOTTLETABLET901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-4049-3EA - Each68788-4049df23a11b-22e6-4984-b8af-d4957479d4c012026-03-17
68788-4049-6EA - Each68788-404950f9ebfc-144e-43e1-83ca-c795f75fc1c212026-03-17
68788-4049-9EA - Each68788-4049534254e1-751a-472f-b2b1-506ac088e3c612026-03-17

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
904467pravastatin sodium 20 MG Oral TabletPSNe6a3d99c-c9cc-49d9-b0f9-503770307b701
904467pravastatin sodium 20 MG Oral TabletSCDe6a3d99c-c9cc-49d9-b0f9-503770307b701

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68788-4049-36878840490330 TABLET in 1 BOTTLE (68788-4049-3) 30 tablet2025-10-31NoNoCurrent
68788-4049-66878840490660 TABLET in 1 BOTTLE (68788-4049-6) 60 tablet2025-10-31NoNoCurrent
68788-4049-96878840490990 TABLET in 1 BOTTLE (68788-4049-9) 90 tablet2025-10-31NoNoCurrent