FDA.reportPublic FDA data

PRAVASTATIN SODIUM

Product NDC
69097-791
11-digit product format
690970791
Labeler code
69097
Product ID
69097-791_0233b0be-de76-4a43-b318-70d14d8955aa
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PRAVASTATIN SODIUM
Dosage form
TABLET
Route
ORAL
Labeler
CIPLA USA INC.
Application
ANDA077987
Marketing category
ANDA
Marketing start
2024-06-01
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
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
69097-791-05PRAVASTATIN SODIUM90 in 1 BOTTLETABLET901
69097-791-12PRAVASTATIN SODIUM500 in 1 BOTTLETABLET5001

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69097-791-05EA - Each69097-79160849558-00e7-4b10-bea3-0e5de3179a0d12024-07-12
69097-791-12EA - Each69097-79139dc86f3-18ce-45ce-b7d8-733a755b6b1412024-07-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69097-791PRAVASTATIN SODIUM TABLET [CIPLA USA INC.]1Current NDC, 2 package rows20240601_678dfe58-3200-4c3d-9718-365aa47d070f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
904458pravastatin sodium 10 MG Oral TabletPSN27ba8a69-b5aa-40eb-89f7-6bf2c1fcceae3
904467pravastatin sodium 20 MG Oral TabletPSN27ba8a69-b5aa-40eb-89f7-6bf2c1fcceae3
904475pravastatin sodium 40 MG Oral TabletPSN27ba8a69-b5aa-40eb-89f7-6bf2c1fcceae3
904481pravastatin sodium 80 MG Oral TabletPSN27ba8a69-b5aa-40eb-89f7-6bf2c1fcceae3
904458pravastatin sodium 10 MG Oral TabletSCD27ba8a69-b5aa-40eb-89f7-6bf2c1fcceae3
904467pravastatin sodium 20 MG Oral TabletSCD27ba8a69-b5aa-40eb-89f7-6bf2c1fcceae3
904475pravastatin sodium 40 MG Oral TabletSCD27ba8a69-b5aa-40eb-89f7-6bf2c1fcceae3
904481pravastatin sodium 80 MG Oral TabletSCD27ba8a69-b5aa-40eb-89f7-6bf2c1fcceae3
904458pravastatin sodium 10 MG Oral TabletPSN97f826f0-b5c5-410c-b1f0-523873981e8d2
904467pravastatin sodium 20 MG Oral TabletPSN97f826f0-b5c5-410c-b1f0-523873981e8d2
904475pravastatin sodium 40 MG Oral TabletPSN97f826f0-b5c5-410c-b1f0-523873981e8d2
904458pravastatin sodium 10 MG Oral TabletSCD97f826f0-b5c5-410c-b1f0-523873981e8d2
904467pravastatin sodium 20 MG Oral TabletSCD97f826f0-b5c5-410c-b1f0-523873981e8d2
904475pravastatin sodium 40 MG Oral TabletSCD97f826f0-b5c5-410c-b1f0-523873981e8d2
904458pravastatin sodium 10 MG Oral TabletPSN678dfe58-3200-4c3d-9718-365aa47d070f1
904467pravastatin sodium 20 MG Oral TabletPSN678dfe58-3200-4c3d-9718-365aa47d070f1
904475pravastatin sodium 40 MG Oral TabletPSN678dfe58-3200-4c3d-9718-365aa47d070f1
904481pravastatin sodium 80 MG Oral TabletPSN678dfe58-3200-4c3d-9718-365aa47d070f1
904458pravastatin sodium 10 MG Oral TabletSCD678dfe58-3200-4c3d-9718-365aa47d070f1
904467pravastatin sodium 20 MG Oral TabletSCD678dfe58-3200-4c3d-9718-365aa47d070f1
904475pravastatin sodium 40 MG Oral TabletSCD678dfe58-3200-4c3d-9718-365aa47d070f1
904481pravastatin sodium 80 MG Oral TabletSCD678dfe58-3200-4c3d-9718-365aa47d070f1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
69097-791-056909707910590 TABLET in 1 BOTTLE (69097-791-05) 90 tablet2024-06-01NoNoCurrent
69097-791-1269097079112500 TABLET in 1 BOTTLE (69097-791-12) 500 tablet2024-06-01NoNoCurrent