Pravastatin sodium

Product NDC
50090-7613
11-digit product format
500907613
Labeler code
50090
Product ID
50090-7613_11589eea-0d70-40b2-93fd-62103cbcee9d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pravastatin sodium
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA209869
Marketing category
ANDA
Marketing start
2021-02-01
Substance
PRAVASTATIN SODIUM
Active strength
40 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 SODIUM40 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii3M8608UQ61
Rxcui904475

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
50090-7613-0Pravastatin sodium90 in 1 BOTTLETABLET901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-7613-0EA - Each50090-76132a623789-3c2b-4814-ace1-5b8a083ca7b312025-08-11

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
904475pravastatin sodium 40 MG Oral TabletPSN33c141e9-76dc-4e32-9b2a-4621f32ac4bd1
904475pravastatin sodium 40 MG Oral TabletSCD33c141e9-76dc-4e32-9b2a-4621f32ac4bd1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50090-7613-05009076130090 TABLET in 1 BOTTLE (50090-7613-0) 90 tablet2025-07-22NoNoHistorical