PRAVASTATIN SODIUM

Product NDC
43063-807
11-digit product format
430630807
Labeler code
43063
Product ID
43063-807_525a0f5a-0780-3089-e063-6294a90a3f1f
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
20 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 SODIUM20 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii3M8608UQ61
Rxcui904467

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
43063-807-30PRAVASTATIN SODIUM30 in 1 BOTTLE, PLASTICTABLET3014

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43063-807-30EA - Each43063-807738212a8-2130-4740-8279-cdbf7f365cb112018-02-20

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43063-807PRAVASTATIN SODIUM TABLET [PD-RX PHARMACEUTICALS, INC.]12Current NDC, Legacy NDC, 1 package rows20240620_2ded7e5e-c377-4495-a045-f1c57b90c5db.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
904467pravastatin sodium 20 MG Oral TabletPSN2ded7e5e-c377-4495-a045-f1c57b90c5db14
904467pravastatin sodium 20 MG Oral TabletSCD2ded7e5e-c377-4495-a045-f1c57b90c5db14

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43063-807-304306308073030 TABLET in 1 BOTTLE, PLASTIC (43063-807-30) 30 tablet2017-02-160000-00-00NoNoCurrent