Pravastatin Sodium

Product NDC
55700-994
11-digit product format
557000994
Labeler code
55700
Product ID
55700-994_35c33ffc-663f-4380-b297-3cedea958b85
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pravastatin Sodium
Dosage form
TABLET
Route
ORAL
Labeler
Quality Care Products, LLC
Application
ANDA077987
Marketing category
ANDA
Marketing start
2023-01-11
Marketing end
2026-10-31
Substance
PRAVASTATIN SODIUM
Active strength
40 mg/1
Pharmacologic classes
HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Pravastatin Sodium

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
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
36361c23-a766-1581-d616-2080c781a50cProduct name520190314
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55700-994-30Pravastatin Sodium30 in 1 BOTTLETABLET302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55700-994PRAVASTATIN SODIUM TABLET [QUALITY CARE PRODUCTS, LLC]2Current NDC, 1 package rows20241222_465dc828-966e-4bb4-b935-ef26583dd4e6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
904475pravastatin sodium 40 MG Oral TabletPSN465dc828-966e-4bb4-b935-ef26583dd4e62
904475pravastatin sodium 40 MG Oral TabletSCD465dc828-966e-4bb4-b935-ef26583dd4e62

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55700-994-305570009943030 TABLET in 1 BOTTLE (55700-994-30) 30 tablet2023-01-112026-10-31NoNoHistorical