PRAVASTATIN SODIUM

Product NDC
43063-808
11-digit product format
430630808
Labeler code
43063
Product ID
43063-808_525a22bd-b919-e11a-e063-6394a90aa6a2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PRAVASTATIN SODIUM
Dosage form
TABLET
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
ANDA207068
Marketing category
ANDA
Marketing start
2017-02-16
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
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
43063-808-30PRAVASTATIN SODIUM30 in 1 BOTTLE, PLASTICTABLET3014

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43063-808-30EA - Each43063-808babe8b46-8c79-41ba-9c1b-77a228c3904912018-02-20

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43063-808PRAVASTATIN SODIUM TABLET [PD-RX PHARMACEUTICALS, INC.]12Current NDC, Legacy NDC, 1 package rows20240620_46fdf929-c961-4dd9-8865-8eb4adaa259a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
904475pravastatin sodium 40 MG Oral TabletPSN46fdf929-c961-4dd9-8865-8eb4adaa259a14
904475pravastatin sodium 40 MG Oral TabletSCD46fdf929-c961-4dd9-8865-8eb4adaa259a14

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43063-808-304306308083030 TABLET in 1 BOTTLE, PLASTIC (43063-808-30) 30 tablet2017-12-110000-00-00NoNoCurrent