FDA.reportPublic FDA data

NDC 0409-8300-25 - 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
0409-8300
Requested NDC
0409-8300-25
Package NDCs from labels
0409-8300-20, 0409-8300-10, 0409-8300-25, 0409-8300-15
Manufacturer
Hospira, Inc.
Effective date
2024-04-02
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Bivalirudin - Hospira, Inc.Hospira, Inc.2024-04-02HUMAN PRESCRIPTION DRUG LABEL
Bivalirudin - Hospira, Inc.Hospira, Inc.2022-12-07HUMAN PRESCRIPTION DRUG LABEL

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0409-8300-10EA - Each0409-83008b09b14a-0165-406e-978c-43d78ec2e14d12015-08-04
0409-8300-15EA - Each0409-8300f33bd043-de9e-41fe-9d30-729c44b927b912015-10-02
0409-8300-20EA - Each0409-83001f64717f-be8c-4a13-8431-e9041fc55d0b12015-08-04
0409-8300-25EA - Each0409-83002d251398-d695-4df9-8004-bd690dd7606212015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BIVALIRUDINACTIVE INGREDIENTTN9BEX005GBIVALIRUDIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [HOSPIRA, INC.]2
BIVALIRUDINACTIVE MOIETYTN9BEX005GBIVALIRUDIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [HOSPIRA, INC.]2
MANNITOLINACTIVE INGREDIENT3OWL53L36ABIVALIRUDIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [HOSPIRA, INC.]2
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IBIVALIRUDIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [HOSPIRA, INC.]2
BIVALIRUDINACTIVE INGREDIENTTN9BEX005GBIVALIRUDIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [HOSPIRA, INC.]1
BIVALIRUDINACTIVE MOIETYTN9BEX005GBIVALIRUDIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [HOSPIRA, INC.]1
MANNITOLINACTIVE INGREDIENT3OWL53L36ABIVALIRUDIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [HOSPIRA, INC.]1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IBIVALIRUDIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [HOSPIRA, INC.]1

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 · 28 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BivalirudinBIVALIRUDINAvenacy, LLC42aa2630-83d6-433d-8277-0f672cf8d71d2026-08-20Warnings, Adverse reactionsExact identifier
unii: TN9BEX005G
BIVALIRUDINBIVALIRUDINEugia US LLCe574d04f-67b4-4a84-9d66-8c2d54f951202026-07-10Warnings, Adverse reactionsExact identifier
unii: TN9BEX005G
MannitolMANNITOLHospira, Inc.8ad3145e-00e7-4412-b9a5-06f00f264f302026-04-21Warnings, Adverse reactionsExact identifier
unii: 3OWL53L36A
e23c5361-366a-4496-b4ca-06efa79a50e39f8f693d-e3bd-449f-0db2-4bb77d6c993c2025-12-05Warnings, Adverse reactionsExact identifier
spl set id: 9f8f693d-e3bd-449f-0db2-4bb77d6c993c
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
unii: TN9BEX005G
BivalirudinBIVALIRUDINFresenius Kabi USA, LLC50975be1-6d1f-497c-b989-1825a0fae1a72025-08-27Warnings, Adverse reactionsExact identifier
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
unii: TN9BEX005G
BivalirudinBIVALIRUDINMylan Institutional LLC95d150e7-f152-4091-b831-e469c9578a542025-03-24Warnings, Adverse reactionsExact identifier
unii: TN9BEX005G
BivalirudinBIVALIRUDINHainan Shuangcheng Pharmaceuticals Co., Ltd.61de12ff-e280-4bab-9804-43869ec45fa72024-12-23Warnings, Adverse reactionsExact identifier
unii: TN9BEX005G
BivalirudinBIVALIRUDINAccord Healthcare, Inc.c20969cb-72d4-469b-9bd8-332250d896c32024-08-15Warnings, Adverse reactionsExact identifier
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
unii: TN9BEX005G
624f6555-6c11-4991-9f02-4c094fdde4b77f3b2717-056e-4edb-a9b0-a63efa008d2b2024-04-02Warnings, Adverse reactionsExact identifier
spl id: 624f6555-6c11-4991-9f02-4c094fdde4b7
spl set id: 7f3b2717-056e-4edb-a9b0-a63efa008d2b

Reported adverse events (FAERS/openFDA)#

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