PRAVASTATIN SODIUM

Product NDC
51655-976
11-digit product format
516550976
Labeler code
51655
Product ID
51655-976_4974c6a5-f17a-71aa-e063-6294a90a81d2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PRAVASTATIN SODIUM
Dosage form
TABLET
Route
ORAL
Labeler
Northwind Health Company, LLC
Application
ANDA076341
Marketing category
ANDA
Marketing start
2022-04-13
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
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 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
51655-976-52PRAVASTATIN SODIUM30 in 1 BOTTLE, PLASTICTABLET304

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51655-976PRAVASTATIN SODIUM TABLET [NORTHWIND PHARMACEUTICALS, LLC]3Current NDC, Legacy NDC, 1 package rows20241228_df75b04e-3e85-9705-e053-2995a90af83f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
904481pravastatin sodium 80 MG Oral TabletPSNdf75b04e-3e85-9705-e053-2995a90af83f4
904481pravastatin sodium 80 MG Oral TabletSCDdf75b04e-3e85-9705-e053-2995a90af83f4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51655-976-525165509765230 TABLET in 1 BOTTLE, PLASTIC (51655-976-52) 30 tablet2022-04-130000-00-00NoNoCurrent