FDA.reportPublic FDA data

Bivalirudin

Product NDC
83634-400
11-digit product format
836340400
Labeler code
83634
Product ID
83634-400_f893cc33-8b26-4b98-848d-61daf2e93a2c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
bivalirudin
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Avenacy, Inc.
Application
ANDA210031
Marketing category
ANDA
Marketing start
2023-12-18
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
83634-400-10Bivalirudin10 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,101
83634-400-41Bivalirudin1 in 1 VIAL, SINGLE-DOSEINJECTION, POWDER, LYOPHILIZED,11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83634-400BIVALIRUDIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [AVENACY, INC.]1Current NDC, 2 package rows20231218_42aa2630-83d6-433d-8277-0f672cf8d71d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308769bivalirudin 250 MG InjectionPSN42aa2630-83d6-433d-8277-0f672cf8d71d1
308769bivalirudin 250 MG InjectionSCD42aa2630-83d6-433d-8277-0f672cf8d71d1
308769bivalirudin 250 MG (as bivalirudin trifluoroacetate 275 MG) per 5 ML InjectionSY42aa2630-83d6-433d-8277-0f672cf8d71d1
308769bivalirudin 50 MG/ML InjectionSY42aa2630-83d6-433d-8277-0f672cf8d71d1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
83634-400-108363404001010 VIAL, SINGLE-DOSE in 1 CARTON (83634-400-10) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (83634-400-41) 2023-12-18NoNoCurrent
83634-400-41836340400411 in 1 VIAL, SINGLE-DOSEHistorical