Pravastatin sodium

Product NDC
48433-148
11-digit product format
484330148
Labeler code
48433
Product ID
48433-148_49ef1f35-49ba-be39-e063-6394a90a9c8d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pravastatin sodium
Dosage form
TABLET
Route
ORAL
Labeler
Safecor Health LLC
Application
ANDA076056
Marketing category
ANDA
Marketing start
2026-01-28
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Pravastatin sodium
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PRAVASTATIN SODIUM20 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii3M8608UQ61
Rxcui904467, 904475

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
48433-148-01Pravastatin sodium1 in 1 BLISTER PACKTABLET14
48433-148-20Pravastatin sodium100 in 1 CARTONTABLET1004

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
48433-148-20EA - Each48433-148bb0214b8-1402-42bc-b7d0-680a1bc69fbe12026-05-22

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
904467pravastatin sodium 20 MG Oral TabletPSN0ae196a4-be3d-4cd8-9ff2-68aeb91b86784
904475pravastatin sodium 40 MG Oral TabletPSN0ae196a4-be3d-4cd8-9ff2-68aeb91b86784
904467pravastatin sodium 20 MG Oral TabletSCD0ae196a4-be3d-4cd8-9ff2-68aeb91b86784
904475pravastatin sodium 40 MG Oral TabletSCD0ae196a4-be3d-4cd8-9ff2-68aeb91b86784

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
48433-148-01484330148011 in 1 BLISTER PACKHistorical
48433-148-2048433014820100 BLISTER PACK in 1 CARTON (48433-148-20) / 1 TABLET in 1 BLISTER PACK (48433-148-01) 100 blister pack2026-01-28NoNoHistorical