FDA.reportPublic FDA data

PRAVASTATIN SODIUM

Product NDC
50268-668
11-digit product format
502680668
Labeler code
50268
Product ID
50268-668_47fb4c90-456b-508c-e063-6394a90a5da5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PRAVASTATIN SODIUM
Dosage form
TABLET
Route
ORAL
Labeler
AvPAK
Application
ANDA076341
Marketing category
ANDA
Marketing start
2021-02-01
Substance
PRAVASTATIN SODIUM
Active strength
80 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 SODIUM80 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
50268-668-11PRAVASTATIN SODIUM1 in 1 BLISTER PACKTABLET16
50268-668-12PRAVASTATIN SODIUM20 in 1 BOXTABLET206

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50268-668-11EA - Each50268-6688893961b-8f06-445e-bc3e-d85b452cb43812021-03-02
50268-668-12EA - Each50268-668b93d29d6-05df-4033-9074-5621ab5e254612021-06-02
50268-668-15EA - Each50268-66855e8b103-8edc-41ab-bc41-7c35fb6c4d6f12021-03-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50268-668PRAVASTATIN SODIUM TABLET [AVPAK]5Current NDC, Legacy NDC, 2 package rows20240110_ba4ac602-46fa-8386-e053-2995a90a9764.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
904458pravastatin sodium 10 MG Oral TabletPSNba4ac602-46fa-8386-e053-2995a90a97646
904467pravastatin sodium 20 MG Oral TabletPSNba4ac602-46fa-8386-e053-2995a90a97646
904475pravastatin sodium 40 MG Oral TabletPSNba4ac602-46fa-8386-e053-2995a90a97646
904481pravastatin sodium 80 MG Oral TabletPSNba4ac602-46fa-8386-e053-2995a90a97646
904458pravastatin sodium 10 MG Oral TabletSCDba4ac602-46fa-8386-e053-2995a90a97646
904467pravastatin sodium 20 MG Oral TabletSCDba4ac602-46fa-8386-e053-2995a90a97646
904475pravastatin sodium 40 MG Oral TabletSCDba4ac602-46fa-8386-e053-2995a90a97646
904481pravastatin sodium 80 MG Oral TabletSCDba4ac602-46fa-8386-e053-2995a90a97646

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50268-668-11502680668111 in 1 BLISTER PACKHistorical
50268-668-125026806681220 BLISTER PACK in 1 BOX (50268-668-12) / 1 TABLET in 1 BLISTER PACK (50268-668-11) 20 blister pack2021-02-010000-00-00NoNoCurrent
50268-668-155026806681550 BLISTER PACK in 1 BOX (50268-668-15) > 1 TABLET in 1 BLISTER PACK (50268-668-11) 50 blister pack2021-02-010000-00-00NoNoCurrent