FDA.reportPublic FDA data

NDC 83634-400-41 - 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
83634-400
Requested NDC
83634-400-41
Package NDCs from labels
83634-400-41, 83634-400-10
Manufacturer
Avenacy, LLC
Effective date
2026-08-20
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Bivalirudin - Avenacy, LLCAvenacy, LLC2026-08-20HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83634-400-10Bivalirudin10 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,101
83634-400-41Bivalirudin1 in 1 VIAL, SINGLE-DOSEINJECTION, POWDER, LYOPHILIZED,11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83634-400BIVALIRUDIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [AVENACY, INC.]1Current NDC, 2 package rows20231218_42aa2630-83d6-433d-8277-0f672cf8d71d.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
83634-400-10EA - Each83634-4003bc0676f-cda0-4e46-9e6c-27a8eea070eb12024-03-12

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.