FDA.reportPublic FDA data

NDC 67457-256-00 - Bivalirudin

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
67457-256
Requested NDC
67457-256-00
Package NDCs from labels
67457-256-00, 67457-256-10
Manufacturer
Mylan Institutional LLC
Effective date
2025-03-24
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Bivalirudin - Mylan Institutional LLCMylan Institutional LLC2025-03-24HUMAN PRESCRIPTION DRUG LABEL

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 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 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

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 2 of 2 · 26 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MannitolMANNITOLB. Braun Medical Inc.d12cc802-b538-4065-a264-f474ff3b30432023-08-15Warnings, Adverse reactionsExact identifier
unii: 3OWL53L36A
MannitolMANNITOLFresenius Kabi USA, LLCc395e13d-6ea1-4104-8b37-669cfb982f042023-03-16Warnings, Adverse reactionsExact identifier
unii: 3OWL53L36A
bivalirudinBIVALIRUDINSlate Run Pharmaceuticals, LLC5d9a45c6-e234-4d56-9132-5e24e65852e62021-06-09Warnings, Adverse reactionsExact identifier
rxcui: 308769
unii: TN9BEX005G
BIVALIRUDINBIVALIRUDINMeitheal Pharmaceuticals Inc.4119b710-ef30-4e3e-b99a-38e42b4b3fca2021-06-08Warnings, Adverse reactionsExact identifier
rxcui: 308769
unii: TN9BEX005G
bivalirudinBIVALIRUDINSandoz Incce56f806-7845-429d-a1ce-c2dbf79b22eb2019-09-30Warnings, Adverse reactionsExact identifier
rxcui: 308769
unii: TN9BEX005G
BivalirudinBIVALIRUDINDr. Reddy's Laboratories Limited19beb2ae-6064-3c24-fe50-0cee868969792019-07-16Warnings, Adverse reactionsExact identifier
rxcui: 308769
unii: TN9BEX005G

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.