Pravastatin Sodium

Product NDC
62135-849
11-digit product format
621350849
Labeler code
62135
Product ID
62135-849_2cf16f1b-c67f-455e-e063-6394a90adc0a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pravastatin Sodium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Chartwell RX, LLC
Application
ANDA077917
Marketing category
ANDA
Marketing start
2024-09-26
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
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 SODIUM40 mg/1

Harmonized Identifiers#

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

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
62135-849-90Pravastatin Sodium90 in 1 BOTTLETABLET, FILM COATED902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62135-849-90EA - Each62135-84925fe51d5-b271-4ced-ac31-d5f9df23795f12024-11-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62135-849PRAVASTATIN SODIUM TABLET, FILM COATED [CHARTWELL RX, LLC]2Current NDC, 1 package rows20250131_f87016fb-4c01-4279-8cf7-59819971ca15.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
904458pravastatin sodium 10 MG Oral TabletPSNf87016fb-4c01-4279-8cf7-59819971ca152
904467pravastatin sodium 20 MG Oral TabletPSNf87016fb-4c01-4279-8cf7-59819971ca152
904475pravastatin sodium 40 MG Oral TabletPSNf87016fb-4c01-4279-8cf7-59819971ca152
904481pravastatin sodium 80 MG Oral TabletPSNf87016fb-4c01-4279-8cf7-59819971ca152
904458pravastatin sodium 10 MG Oral TabletSCDf87016fb-4c01-4279-8cf7-59819971ca152
904467pravastatin sodium 20 MG Oral TabletSCDf87016fb-4c01-4279-8cf7-59819971ca152
904475pravastatin sodium 40 MG Oral TabletSCDf87016fb-4c01-4279-8cf7-59819971ca152
904481pravastatin sodium 80 MG Oral TabletSCDf87016fb-4c01-4279-8cf7-59819971ca152

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
62135-849-906213508499090 TABLET, FILM COATED in 1 BOTTLE (62135-849-90) 2024-09-26NoNoHistorical