FDA.reportPublic FDA data

NDC 72572-035-01 - 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
72572-035
Requested NDC
72572-035-01
Package NDCs from labels
72572-035-01, 72572-035-10
Manufacturer
Civica, Inc.
Effective date
2025-09-10
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
bivalirudin - Civica, Inc.Civica, Inc.2025-09-10HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
72572-035-102025-09-11C16284748780-13b156c62-26ee-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
72572-035-102025-07-29C16284748780-13b156c62-26ee-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
72572-035-01bivalirudin1 in 1 VIAL, SINGLE-USEINJECTION, POWDER, LYOPHILIZED,12
72572-035-10bivalirudin10 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,102

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72572-035BIVALIRUDIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [CIVICA, INC.]1Current NDC, Legacy NDC, 2 package rows20201221_19a4afc5-151d-4d3c-bfef-48aa8797d695.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72572-035-01EA - Each72572-0357c2971d0-3f34-4732-8722-d0be4aef66ac12021-01-08
72572-035-10EA - Each72572-035ac27ca37-d27c-4784-8180-056baa0d016d12021-01-08

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 1 of 2 · 26 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BivalirudinBIVALIRUDINAvenacy, LLC42aa2630-83d6-433d-8277-0f672cf8d71d2026-08-20Warnings, Adverse reactionsExact identifier
rxcui: 308769
unii: TN9BEX005G
BIVALIRUDINBIVALIRUDINEugia US LLCe574d04f-67b4-4a84-9d66-8c2d54f951202026-07-10Warnings, Adverse reactionsExact identifier
rxcui: 308769
unii: TN9BEX005G
MannitolMANNITOLHospira, Inc.8ad3145e-00e7-4412-b9a5-06f00f264f302026-04-21Warnings, Adverse reactionsExact identifier
unii: 3OWL53L36A
QR PAINANALGESICMARYHELENE ENTERPRISES INC8f8f53e3-fe31-e7b5-e053-2995a90a710d2025-11-14WarningsExact identifier
unii: 3OWL53L36A
QR PAINANALGESICMARYHELENE ENTERPRISES INC9984a510-30be-4013-e053-2995a90a841e2025-11-14WarningsExact identifier
unii: 3OWL53L36A
MannitolMANNITOLProPharma Distribution430669d7-9ad1-9a04-e063-6394a90ababb2025-11-07Warnings, Adverse reactionsExact identifier
unii: 3OWL53L36A
Sorbitol-MannitolSORBITOL AND MANNITOLICU Medical Inc.5b44e248-4b7b-4777-954a-921c7b3099442025-10-30Warnings, Adverse reactionsExact identifier
unii: 3OWL53L36A
MannitolMANNITOLICU Medical Inc.ba7bf864-8a4d-4262-8fd1-00174fa2f9d12025-10-24Warnings, Adverse reactionsExact identifier
unii: 3OWL53L36A
bivalirudinBIVALIRUDINCivica, Inc.19a4afc5-151d-4d3c-bfef-48aa8797d6952025-09-10Warnings, Adverse reactionsExact identifier
application number: NDA020873
ndc (package): 72572-035-01
ndc (package): 72572-035-10
ndc (product): 72572-035
ndc11 (package): 72572003501
rxcui: 308769
spl id: 53431803-dc0b-42dc-8766-e17c3dbdf4ea
spl set id: 19a4afc5-151d-4d3c-bfef-48aa8797d695
unii: TN9BEX005G
BivalirudinBIVALIRUDINFresenius Kabi USA, LLC50975be1-6d1f-497c-b989-1825a0fae1a72025-08-27Warnings, Adverse reactionsExact identifier
rxcui: 308769
unii: TN9BEX005G
OsmitrolMANNITOLBaxter Healthcare Company0d914965-7001-45cb-ba51-d7c5964b05bc2025-08-26Warnings, Adverse reactionsExact identifier
unii: 3OWL53L36A
MannitolMANNITOLHenry Schein, Inc.e2444db1-9dfe-451f-a33c-9b00786464d22025-05-20Warnings, Adverse reactionsExact identifier
unii: 3OWL53L36A
BivalirudinBIVALIRUDINFresenius Kabi USA, LLCaf943fa0-ab0f-4b62-9ff0-54ee24cdb7722025-05-08Warnings, Adverse reactionsExact identifier
rxcui: 308769
unii: TN9BEX005G
BivalirudinBIVALIRUDINMylan Institutional LLC95d150e7-f152-4091-b831-e469c9578a542025-03-24Warnings, Adverse reactionsExact identifier
rxcui: 308769
unii: TN9BEX005G
BivalirudinBIVALIRUDINHainan Shuangcheng Pharmaceuticals Co., Ltd.61de12ff-e280-4bab-9804-43869ec45fa72024-12-23Warnings, Adverse reactionsExact identifier
rxcui: 308769
unii: TN9BEX005G
BivalirudinBIVALIRUDINAccord Healthcare, Inc.c20969cb-72d4-469b-9bd8-332250d896c32024-08-15Warnings, Adverse reactionsExact identifier
rxcui: 308769
unii: TN9BEX005G
BivalirudinBIVALIRUDINMAIA Pharmaceuticals, Inc.c727199d-f4cd-4658-8fdf-568590beface2024-05-27Warnings, Adverse reactionsExact identifier
unii: TN9BEX005G
BIVALIRUDINBIVALIRUDINMeitheal Pharmaceuticals Inc.26fb46f6-0088-42b8-b6f2-c672247768032024-04-04Warnings, Adverse reactionsExact identifier
rxcui: 308769
unii: TN9BEX005G
BivalirudinBIVALIRUDINPar Health USA, LLC91cf9d00-29e0-4357-a184-f70026c47edb2024-03-01Warnings, Adverse reactionsExact identifier
unii: TN9BEX005G
MANNITOLMANNITOLHF Acquisition Co LLC, DBA HealthFirst999ce711-2d5b-0d7d-e053-2995a90a26892024-01-27Warnings, Adverse reactionsExact identifier
unii: 3OWL53L36A

Reported adverse events (FAERS/openFDA)#

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