FDA.reportPublic FDA data

BIVALIRUDIN

Product NDC
71288-427
11-digit product format
712880427
Labeler code
71288
Product ID
71288-427_2b20b742-4bab-4e5b-9d1b-9a7ca9e0daf7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
BIVALIRUDIN
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Meitheal Pharmaceuticals Inc.
Application
ANDA091602
Marketing category
ANDA
Marketing start
2018-07-16
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
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
71288-427-10BIVALIRUDIN5 mL in 1 VIAL, SINGLE-DOSEINJECTION, POWDER, LYOPHILIZED,52
71288-427-11BIVALIRUDIN10 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,102
71288-427-91BIVALIRUDIN5 mL in 1 VIAL, SINGLE-DOSEINJECTION, POWDER, LYOPHILIZED,51
71288-427-92BIVALIRUDIN10 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,101

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71288-427-10EA - Each71288-4272c2eb2b4-98e5-48ed-9ed9-c79940ba753e12021-12-08
71288-427-11EA - Each71288-42714e1f3c4-dd93-4b33-b000-272c9f47810b12021-12-08
71288-427-91EA - Each71288-42769cf98ed-2542-4c19-89ca-9732d144a98a12024-07-12
71288-427-92EA - Each71288-427fe0be6b1-59fc-401c-b3ba-42d26b01b3a312024-07-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71288-427BIVALIRUDIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MEITHEAL PHARMACEUTICALS INC.]2Current NDC, Legacy NDC, 2 package rows20210610_4119b710-ef30-4e3e-b99a-38e42b4b3fca.zip
71288-427BIVALIRUDIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MEITHEAL PHARMACEUTICALS INC.]1Current NDC, Legacy NDC, 2 package rows20240405_26fb46f6-0088-42b8-b6f2-c67224776803.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308769bivalirudin 250 MG InjectionPSN4119b710-ef30-4e3e-b99a-38e42b4b3fca2
308769bivalirudin 250 MG InjectionSCD4119b710-ef30-4e3e-b99a-38e42b4b3fca2
308769bivalirudin 250 MG (as bivalirudin trifluoroacetate 275 MG) per 5 ML InjectionSY4119b710-ef30-4e3e-b99a-38e42b4b3fca2
308769bivalirudin 50 MG/ML InjectionSY4119b710-ef30-4e3e-b99a-38e42b4b3fca2
308769bivalirudin 250 MG InjectionPSN26fb46f6-0088-42b8-b6f2-c672247768031
308769bivalirudin 250 MG InjectionSCD26fb46f6-0088-42b8-b6f2-c672247768031
308769bivalirudin 250 MG (as bivalirudin trifluoroacetate 275 MG) per 5 ML InjectionSY26fb46f6-0088-42b8-b6f2-c672247768031
308769bivalirudin 50 MG/ML InjectionSY26fb46f6-0088-42b8-b6f2-c672247768031

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71288-427-10712880427105 mL in 1 VIAL, SINGLE-DOSE5 mlHistorical
71288-427-117128804271110 VIAL, SINGLE-DOSE in 1 CARTON (71288-427-11) / 5 mL in 1 VIAL, SINGLE-DOSE (71288-427-10) 2018-07-160000-00-00NoNoCurrent
71288-427-91712880427915 mL in 1 VIAL, SINGLE-DOSE5 mlHistorical
71288-427-927128804279210 VIAL, SINGLE-DOSE in 1 CARTON (71288-427-92) / 5 mL in 1 VIAL, SINGLE-DOSE (71288-427-91) 2018-07-16NoNoHistorical