FDA.reportPublic FDA data

PRAVASTATIN SODIUM

Product NDC
16729-008
11-digit product format
167290008
Labeler code
16729
Product ID
16729-008_438f9112-0851-75e1-e063-6294a90a675c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PRAVASTATIN SODIUM
Dosage form
TABLET
Route
ORAL
Labeler
Accord Healthcare Inc.
Application
ANDA207068
Marketing category
ANDA
Marketing start
2017-02-16
Substance
PRAVASTATIN SODIUM
Active strength
10 mg/1
Pharmacologic classes
HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
PRAVASTATIN SODIUM
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PRAVASTATIN SODIUM10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii3M8608UQ61
Rxcui904458, 904467, 904475, 904481

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
16729-008-15PRAVASTATIN SODIUM90 in 1 BOTTLETABLET9010
16729-008-16PRAVASTATIN SODIUM500 in 1 BOTTLETABLET50010
16729-008-17PRAVASTATIN SODIUM1000 in 1 BOTTLETABLET100010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16729-008-15EA - Each16729-008e9a45a59-b3b4-4bc3-abe4-d573bd1d552312017-03-06
16729-008-16EA - Each16729-0089ed940e9-daa9-4502-bc93-e3dfed19e5c912017-03-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16729-008PRAVASTATIN SODIUM TABLET [ACCORD HEALTHCARE INC.]9Current NDC, Legacy NDC, 3 package rows20240103_6c011348-a236-47d3-bbef-3e0b956dd080.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
904458pravastatin sodium 10 MG Oral TabletPSN6c011348-a236-47d3-bbef-3e0b956dd08010
904467pravastatin sodium 20 MG Oral TabletPSN6c011348-a236-47d3-bbef-3e0b956dd08010
904475pravastatin sodium 40 MG Oral TabletPSN6c011348-a236-47d3-bbef-3e0b956dd08010
904481pravastatin sodium 80 MG Oral TabletPSN6c011348-a236-47d3-bbef-3e0b956dd08010
904458pravastatin sodium 10 MG Oral TabletSCD6c011348-a236-47d3-bbef-3e0b956dd08010
904467pravastatin sodium 20 MG Oral TabletSCD6c011348-a236-47d3-bbef-3e0b956dd08010
904475pravastatin sodium 40 MG Oral TabletSCD6c011348-a236-47d3-bbef-3e0b956dd08010
904481pravastatin sodium 80 MG Oral TabletSCD6c011348-a236-47d3-bbef-3e0b956dd08010
904458pravastatin sodium 10 MG Oral TabletPSN7d660b83-99fa-6ef2-e053-2991aa0a9d973
904458pravastatin sodium 10 MG Oral TabletSCD7d660b83-99fa-6ef2-e053-2991aa0a9d973

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
16729-008-151672900081590 TABLET in 1 BOTTLE (16729-008-15) 90 tablet2017-02-160000-00-00NoNoCurrent
16729-008-1616729000816500 TABLET in 1 BOTTLE (16729-008-16) 500 tablet2017-02-160000-00-00NoNoCurrent
16729-008-17167290008171000 in 1 BOTTLEHistorical