FDA.reportPublic FDA data

NDC 55111-652-07 - 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
55111-652
Requested NDC
55111-652-07
Package NDCs from labels
55111-652-07, 55111-652-37
Manufacturer
Dr. Reddy's Laboratories Limited | Gland Pharma Limited
Effective date
2019-07-16
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Bivalirudin - Dr. Reddy's Laboratories Limited | Gland Pharma LimitedDr. Reddy's Laboratories Limited | Gland Pharma Limited2019-07-16HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55111-652-07Bivalirudin1 in 1 VIAL, SINGLE-DOSEINJECTION110
55111-652-37Bivalirudin10 in 1 CARTONINJECTION1010

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55111-652BIVALIRUDIN INJECTION [DR. REDDY'S LABORATORIES LIMITED]10Current NDC, Legacy NDC, 2 package rows20240627_19beb2ae-6064-3c24-fe50-0cee86896979.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55111-652-07EA - Each55111-652e5d2ff6f-ccb8-420c-97e0-a3131355bcc912017-06-15
55111-652-37EA - Each55111-652c0cc8f72-d88c-487a-bbcb-c72636d666c212017-06-15

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
application number: ANDA201577
ndc (package): 55111-652-37
ndc (package): 55111-652-07
ndc (product): 55111-652
ndc11 (package): 55111065207
rxcui: 308769
spl id: 2c95d0ae-12a5-4981-d4cf-99e26a7f5a69
spl set id: 19beb2ae-6064-3c24-fe50-0cee86896979
unii: TN9BEX005G

Reported adverse events (FAERS/openFDA)#

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