Pravastatin Sodium

Product NDC
51655-594
11-digit product format
516550594
Labeler code
51655
Product ID
51655-594_494f01b2-8512-f5a5-e063-6294a90ab408
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pravastatin Sodium
Dosage form
TABLET
Route
ORAL
Labeler
Northwind Health Company, LLC
Application
ANDA077987
Marketing category
ANDA
Marketing start
2021-02-03
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
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 SODIUM40 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii3M8608UQ61
Rxcui904475

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
51655-594-52Pravastatin Sodium30 in 1 BOTTLE, PLASTICTABLET304

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51655-594PRAVASTATIN SODIUM TABLET [NORTHWIND PHARMACEUTICALS, LLC]3Current NDC, 1 package rows20241225_db0e9c21-dc25-629a-e053-2a95a90a5ac3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
904475pravastatin sodium 40 MG Oral TabletPSNdb0e9c21-dc25-629a-e053-2a95a90a5ac34
904475pravastatin sodium 40 MG Oral TabletSCDdb0e9c21-dc25-629a-e053-2a95a90a5ac34

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
51655-594-525165505945230 TABLET in 1 BOTTLE, PLASTIC (51655-594-52) 30 tablet2021-02-03NoNoCurrent