FDA.reportPublic FDA data

Bivalirudin

Product NDC
55111-652
11-digit product format
551110652
Labeler code
55111
Product ID
55111-652_2c95d0ae-12a5-4981-d4cf-99e26a7f5a69
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Bivalirudin
Dosage form
INJECTION
Route
INTRACAVERNOUS
Labeler
Dr. Reddy's Laboratories Limited
Application
ANDA201577
Marketing category
ANDA
Marketing start
2017-05-31
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
55111-652-07Bivalirudin1 in 1 VIAL, SINGLE-DOSEINJECTION110
55111-652-37Bivalirudin10 in 1 CARTONINJECTION1010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55111-652-07EA - Each55111-652e5d2ff6f-ccb8-420c-97e0-a3131355bcc912017-06-15
55111-652-37EA - Each55111-652c0cc8f72-d88c-487a-bbcb-c72636d666c212017-06-15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55111-652BIVALIRUDIN INJECTION [DR. REDDY'S LABORATORIES LIMITED]10Current NDC, Legacy NDC, 2 package rows20240627_19beb2ae-6064-3c24-fe50-0cee86896979.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308769bivalirudin 250 MG InjectionPSN19beb2ae-6064-3c24-fe50-0cee8689697910
308769bivalirudin 250 MG InjectionSCD19beb2ae-6064-3c24-fe50-0cee8689697910
308769bivalirudin 250 MG (as bivalirudin trifluoroacetate 275 MG) per 5 ML InjectionSY19beb2ae-6064-3c24-fe50-0cee8689697910
308769bivalirudin 50 MG/ML InjectionSY19beb2ae-6064-3c24-fe50-0cee8689697910

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
55111-652-07551110652071 in 1 VIAL, SINGLE-DOSEHistorical
55111-652-375511106523710 VIAL, SINGLE-DOSE in 1 CARTON (55111-652-37) / 1 INJECTION in 1 VIAL, SINGLE-DOSE (55111-652-07) 2017-05-310000-00-00NoNoCurrent