FDA.reportPublic FDA data

bivalirudin

Product NDC
72572-035
11-digit product format
725720035
Labeler code
72572
Product ID
72572-035_53431803-dc0b-42dc-8766-e17c3dbdf4ea
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
bivalirudin
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Civica, Inc.
Application
NDA020873
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2020-12-21
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
72572-035-102025-09-11C16284748780-13b156c62-26ee-fb37-e063-e6dba90a4e07These highlights do not include all the information needed to use BIVALIRUDIN FOR INJECTION safely and effectively. See full prescribing information for BIVALIRUDIN FOR INJECTION. BIVALIRUDIN for injection, for intravenous use Initial U.S. Approval: 2000
72572-035-102025-07-29C16284748780-13b156c62-26ee-fb37-e063-e6dba90a4e07These highlights do not include all the information needed to use BIVALIRUDIN FOR INJECTION safely and effectively. See full prescribing information for BIVALIRUDIN FOR INJECTION. BIVALIRUDIN for injection, for intravenous use Initial U.S. Approval: 2000

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72572-035-01bivalirudin1 in 1 VIAL, SINGLE-USEINJECTION, POWDER, LYOPHILIZED,12
72572-035-10bivalirudin10 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,102

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72572-035-01EA - Each72572-0357c2971d0-3f34-4732-8722-d0be4aef66ac12021-01-08
72572-035-10EA - Each72572-035ac27ca37-d27c-4784-8180-056baa0d016d12021-01-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72572-035BIVALIRUDIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [CIVICA, INC.]1Current NDC, Legacy NDC, 2 package rows20201221_19a4afc5-151d-4d3c-bfef-48aa8797d695.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308769bivalirudin 250 MG InjectionPSN19a4afc5-151d-4d3c-bfef-48aa8797d6952
308769bivalirudin 250 MG InjectionSCD19a4afc5-151d-4d3c-bfef-48aa8797d6952
308769bivalirudin 250 MG (as bivalirudin trifluoroacetate 275 MG) per 5 ML InjectionSY19a4afc5-151d-4d3c-bfef-48aa8797d6952
308769bivalirudin 50 MG/ML InjectionSY19a4afc5-151d-4d3c-bfef-48aa8797d6952

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
72572-035-01725720035011 in 1 VIAL, SINGLE-USEHistorical
72572-035-107257200351010 VIAL, SINGLE-USE in 1 CARTON (72572-035-10) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-USE (72572-035-01) 2020-12-210000-00-00NoNoCurrent