FDA.reportPublic FDA data

Bivalirudin

Product NDC
67457-256
11-digit product format
674570256
Labeler code
67457
Product ID
67457-256_664ba93e-5cde-4a01-bc5c-17ed394652e8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
bivalirudin
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Mylan Institutional LLC
Application
ANDA202471
Marketing category
ANDA
Marketing start
2018-06-05
Substance
BIVALIRUDIN
Active strength
250 mg/5mL
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/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiTN9BEX005G
Rxcui308769

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
1c25cd48-e81c-4683-ac07-71f9a642e2bfProduct name920211217
325b79a5-b460-45d7-abfc-c4784f5b0531Product name120191120
c3370853-5a7f-4c73-a273-26ef0162f2f3Product name120180308

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67457-256-00Bivalirudin5 mL in 1 VIAL, SINGLE-DOSEINJECTION, POWDER, LYOPHILIZED,58
67457-256-10Bivalirudin10 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,108

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67457-256-00EA - Each67457-256f26f7621-9e8b-4f0a-a2db-5f2866a0293f12018-07-03
67457-256-10EA - Each67457-256687f6b22-c003-4392-ad01-07e20ac427ea12018-07-03

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67457-256BIVALIRUDIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MYLAN INSTITUTIONAL LLC]7Current NDC, Legacy NDC, 2 package rows20240123_95d150e7-f152-4091-b831-e469c9578a54.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308769bivalirudin 250 MG InjectionPSN95d150e7-f152-4091-b831-e469c9578a548
308769bivalirudin 250 MG InjectionSCD95d150e7-f152-4091-b831-e469c9578a548
308769bivalirudin 250 MG (as bivalirudin trifluoroacetate 275 MG) per 5 ML InjectionSY95d150e7-f152-4091-b831-e469c9578a548
308769bivalirudin 50 MG/ML InjectionSY95d150e7-f152-4091-b831-e469c9578a548

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67457-256-00674570256005 mL in 1 VIAL, SINGLE-DOSE5 mlHistorical
67457-256-106745702561010 VIAL, SINGLE-DOSE in 1 CARTON (67457-256-10) / 5 mL in 1 VIAL, SINGLE-DOSE (67457-256-00) 2018-06-050000-00-00NoNoCurrent