FDA.reportPublic FDA data

bivalirudin

Product NDC
70436-025
11-digit product format
704360025
Labeler code
70436
Product ID
70436-025_c44f8757-1a09-ab1e-e053-2a95a90a44e1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
bivalirudin
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION
Route
INTRAVENOUS
Labeler
Slate Run Pharmaceuticals, LLC
Application
ANDA213078
Marketing category
ANDA
Marketing start
2021-06-30
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
325b79a5-b460-45d7-abfc-c4784f5b0531Product name120191120
c3370853-5a7f-4c73-a273-26ef0162f2f3Product name120180308

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70436-025-80bivalirudin1 in 1 VIAL, SINGLE-DOSEINJECTION, POWDER, LYOPHILIZED,11
70436-025-82bivalirudin10 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,101

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70436-025-80EA - Each70436-0258ccea3a8-ebf1-4aaf-9164-01eadc61219b12022-01-06
70436-025-82EA - Each70436-025eeb260fd-7933-47e8-b569-91f6c19276f912022-01-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70436-025BIVALIRUDIN INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION [SLATE RUN PHARMACEUTICALS, LLC]1Current NDC, Legacy NDC, 2 package rows20210630_5d9a45c6-e234-4d56-9132-5e24e65852e6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308769bivalirudin 250 MG InjectionPSN5d9a45c6-e234-4d56-9132-5e24e65852e61
308769bivalirudin 250 MG InjectionSCD5d9a45c6-e234-4d56-9132-5e24e65852e61
308769bivalirudin 250 MG (as bivalirudin trifluoroacetate 275 MG) per 5 ML InjectionSY5d9a45c6-e234-4d56-9132-5e24e65852e61
308769bivalirudin 50 MG/ML InjectionSY5d9a45c6-e234-4d56-9132-5e24e65852e61

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70436-025-80704360025801 INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION in 1 VIAL, SINGLE-DOSE (70436-025-80) 2021-06-300000-00-00NoNoCurrent
70436-025-827043600258210 INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION in 1 CARTON (70436-025-82) 2021-06-300000-00-00NoNoCurrent