FDA.reportPublic FDA data

Bivalirudin

Product NDC
63323-562
11-digit product format
633230562
Labeler code
63323
Product ID
63323-562_2f51e657-4541-4458-8020-5063efc51eb7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Bivalirudin
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Fresenius Kabi USA, LLC
Application
ANDA090189
Marketing category
ANDA
Marketing start
2016-10-28
Substance
BIVALIRUDIN
Active strength
250 mg/1
Pharmacologic classes
Anti-coagulant [EPC], Direct Thrombin Inhibitor [EPC], Thrombin 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
Bivalirudin
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BIVALIRUDIN250 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiTN9BEX005G
Rxcui308769

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
1c25cd48-e81c-4683-ac07-71f9a642e2bfProduct name920211217
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
325b79a5-b460-45d7-abfc-c4784f5b0531Product name120191120
c3370853-5a7f-4c73-a273-26ef0162f2f3Product name120180308
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63323-562-10Bivalirudin1 in 1 VIAL, SINGLE-USEINJECTION, POWDER, LYOPHILIZED,15
63323-562-10Bivalirudin10 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,105
63323-562-15Bivalirudin10 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,104
63323-562-41Bivalirudin1 in 1 VIAL, SINGLE-USEINJECTION, POWDER, LYOPHILIZED,14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63323-562-10EA - Each63323-56211895a43-546a-476a-9a2f-dbbd05c6703112016-11-08
63323-562-15EA - Each63323-562430d6d8d-936f-4775-a879-52ebbe87a83e12018-01-12
63323-562-41EA - Each63323-56246d173a0-2449-4296-b8c6-4f9ca6b95bf612018-01-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63323-562BIVALIRUDIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC ]4Current NDC, Legacy NDC, 2 package rows20210123_af943fa0-ab0f-4b62-9ff0-54ee24cdb772.zip
63323-562BIVALIRUDIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC ]3Current NDC, Legacy NDC, 2 package rows20210616_50975be1-6d1f-497c-b989-1825a0fae1a7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308769bivalirudin 250 MG InjectionPSNaf943fa0-ab0f-4b62-9ff0-54ee24cdb7725
308769bivalirudin 250 MG InjectionSCDaf943fa0-ab0f-4b62-9ff0-54ee24cdb7725
308769bivalirudin 250 MG (as bivalirudin trifluoroacetate 275 MG) per 5 ML InjectionSYaf943fa0-ab0f-4b62-9ff0-54ee24cdb7725
308769bivalirudin 50 MG/ML InjectionSYaf943fa0-ab0f-4b62-9ff0-54ee24cdb7725
308769bivalirudin 250 MG InjectionPSN50975be1-6d1f-497c-b989-1825a0fae1a74
308769bivalirudin 250 MG InjectionSCD50975be1-6d1f-497c-b989-1825a0fae1a74
308769bivalirudin 250 MG (as bivalirudin trifluoroacetate 275 MG) per 5 ML InjectionSY50975be1-6d1f-497c-b989-1825a0fae1a74
308769bivalirudin 50 MG/ML InjectionSY50975be1-6d1f-497c-b989-1825a0fae1a74

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63323-562-106332305621010 VIAL, SINGLE-USE in 1 CARTON (63323-562-10) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-USE2016-10-280000-00-00NoNoCurrent
63323-562-156332305621510 VIAL, SINGLE-USE in 1 CARTON (63323-562-15) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-USE (63323-562-41) 2017-10-300000-00-00NoNoCurrent
63323-562-41633230562411 in 1 VIAL, SINGLE-USEHistorical