FDA.reportPublic FDA data

bivalirudin

Product NDC
0781-3158
11-digit product format
007813158
Labeler code
0781
Product ID
0781-3158_6260b3ba-2bf2-4196-a9f6-4e7e159be5a6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
bivalirudin
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Sandoz Inc
Application
NDA020873
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2015-06-15
Marketing end
0000-00-00
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
2020-12-31
Current FDA listing
Historical FDA.report record

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0781-3158-952025-07-29C16284748780-13b156c62-261e-fb37-e063-e6dba90a4e07These highlights do not include all the information needed to use BIVALIRUDIN FOR INJECTION safely and effectively. See full prescribing information for BIVALIRUDIN FOR INJECTION. BIVALIRUDIN for injection, for intravenous use Initial U.S. Approval: 2000

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0781-3158-94bivalirudin1 in 1 VIAL, SINGLE-USEINJECTION, POWDER, LYOPHILIZED,14
0781-3158-95bivalirudin10 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,104

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0781-3158-94EA - Each0781-3158d028d52b-d61b-4c8e-9fab-17b50274cf9712015-08-04
0781-3158-95EA - Each0781-3158528c27e3-6b76-4343-97f5-3f2974930f2f12015-08-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BIVALIRUDINACTIVE INGREDIENTTN9BEX005GBIVALIRUDIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [SANDOZ]1
BIVALIRUDINACTIVE MOIETYTN9BEX005GBIVALIRUDIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [SANDOZ]1
MANNITOLINACTIVE INGREDIENT3OWL53L36ABIVALIRUDIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [SANDOZ]1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IBIVALIRUDIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [SANDOZ]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0781-3158BIVALIRUDIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [SANDOZ INC]4Legacy NDC, 2 package rows20191003_ce56f806-7845-429d-a1ce-c2dbf79b22eb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308769bivalirudin 250 MG InjectionPSNce56f806-7845-429d-a1ce-c2dbf79b22eb4
308769bivalirudin 250 MG InjectionSCDce56f806-7845-429d-a1ce-c2dbf79b22eb4
308769bivalirudin 250 MG (as bivalirudin trifluoroacetate 275 MG) per 5 ML InjectionSYce56f806-7845-429d-a1ce-c2dbf79b22eb4
308769bivalirudin 50 MG/ML InjectionSYce56f806-7845-429d-a1ce-c2dbf79b22eb4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0781-3158-94007813158941 in 1 VIAL, SINGLE-USEHistorical
0781-3158-950078131589510 VIAL, SINGLE-USE in 1 CARTON (0781-3158-95) > 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-USE (0781-3158-94) 2015-06-150000-00-00NoNoCurrent