FDA.reportPublic FDA data

NDC 70860-403-50 - Bivalirudin RTU

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
70860-403
Requested NDC
70860-403-50
Package NDCs from labels
70860-403-50, 70860-403-51
Manufacturer
Athenex Pharmaceutical Division, LLC.
Effective date
2024-03-02
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Bivalirudin RTU - Athenex Pharmaceutical Division, LLC.Athenex Pharmaceutical Division, LLC.2024-03-02HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70860-403-512024-03-02C16284748780-11030e365-5946-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use BIVALIRUDIN RTU INJECTION safely and effectively. See full prescribing information for BIVALIRUDIN RTU INJECTION. BIVALIRUDIN RTU (bivalirudin) injection, for intravenous use Initial U.S. Approval: 2000
70860-403-512024-01-30C16284748780-11030e365-5946-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use BIVALIRUDIN RTU INJECTION safely and effectively. See full prescribing information for BIVALIRUDIN RTU INJECTION. BIVALIRUDIN RTU (bivalirudin) injection, for intravenous use Initial U.S. Approval: 2000

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70860-403-50ML - Milliliter70860-4036b458038-5c20-427d-9e96-893b2c7c354712020-03-10
70860-403-51ML - Milliliter70860-403311de9e9-6aaf-4720-aadc-2eeec21a9f0612020-03-10

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 9 of 20 · 385 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sterile WaterSTERILE WATERNephron Pharmaceuticals Corporationbc04a883-babc-87a6-e053-2995a90a3dfd2025-07-11Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Hydrocortisone and Acetic AcidHYDROCORTISONE AND ACETIC ACIDSun Pharmaceutical Industries, Inc.6383c722-84e2-4719-a13d-19c54e3eefff2025-07-07Warnings, Adverse reactionsExact identifier
unii: Q40Q9N063P
InterSolPLATELET ADDITIVE 3Fenwal, Inc.17dec820-1b57-4ac9-82a8-419cab664a2f2025-06-27Warnings, Adverse reactionsExact identifier
unii: 4550K0SC9B
Plaque identifyingPLAQUE IDENTIFYINGShenzhen Yagao Technology Co., Ltd.37eeb656-22f1-7372-e063-6394a90ad0412025-06-19WarningsExact identifier
unii: 059QF0KO0R
Visine Red Eye Hydrating Comfort Eye DropsTETRAHYDROZOLINE HYDROCHLORIDE AND POLYETHYLENE GLYCOL 400Morning Star OTCdcd4164c-aa1e-4f07-ab2c-b439275629db2025-06-16WarningsExact identifier
unii: B697894SGQ
Sterile WaterWATERHenry Schein, Inc.88403fcf-a276-42c0-88b6-bd84a720b5642025-05-29Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Eyesaline Emergency EyewashSTERILE EYESALINE EYEWASHHoneywell Safety Products USA, Inc.2d567518-4c54-7448-e063-6294a90a3e642025-05-14WarningsExact identifier
unii: 059QF0KO0R
BivalirudinBIVALIRUDINFresenius Kabi USA, LLCaf943fa0-ab0f-4b62-9ff0-54ee24cdb7722025-05-08Warnings, Adverse reactionsExact identifier
unii: TN9BEX005G
hydrocortisone and acetic acidHYDROCORTISONE AND ACETIC ACID OTICSaptalis Pharmaceuticals, LLCd9a3597c-2c9d-46cc-818b-8bb3aa5c4f322025-04-25Warnings, Adverse reactionsExact identifier
unii: Q40Q9N063P
Eye WashWATERCMC Group Inc.6158a1f5-a6bc-4a3e-9d1d-0a310d9dc5612025-04-02WarningsExact identifier
unii: 059QF0KO0R
BivalirudinBIVALIRUDINMylan Institutional LLC95d150e7-f152-4091-b831-e469c9578a542025-03-24Warnings, Adverse reactionsExact identifier
unii: TN9BEX005G
Bestmade Natural Products Field of Flowers FormulaAESCULUS CAR, AESCULUS HIP, AGRIMONIA EUP, BROMUS RAM, CALLUNA VULG, CARPINUS BET, CASTANEA SAT, CENTAURIUM UMB, CERATOSTIGMA WILLM, CICHORIUM INT, CLEMATIS VIT, FAGUS SYLV, GENTIANELLA AMARELLA, HELIANTHEMUM NUMMULARIUM, ILEX AQUIFOLIUM, IMPATIENS GLAND, LARIX DECIDUA, LONICERA CAPRIFOLIUM, MALUS, MIMULUS GUT, OLEA EUROP, ORNITHOGALUM UMB, PINUS SYL, POPULUS TREM, PRUNUS CERA, QUERCUS ROB, ROCK WATER, ROSA CAN, SALIX VIT, SCLERANTHUS ANNNUS, SINAPIS ARV, ULEX EURO, ULMUS PROC, VERBENA, VITIS VINBestmade Natural Products2fbf9b7c-e54f-589d-e063-6394a90a14a72025-03-07WarningsExact identifier
unii: 059QF0KO0R
AeroWash EyewashEYEWASH SOLUTIONAero Healthcare US LLCa477de08-4301-0ee5-e053-2995a90af79d2025-02-26WarningsExact identifier
unii: 059QF0KO0R
Advanced Eye Relief Eye WashWATER SOLUTIONBausch & Lomb Incorporated9caccce1-4530-441d-bf76-244edeb9dedc2025-02-17WarningsExact identifier
unii: 059QF0KO0R
Acetic AcidACETIC ACIDNuCare Pharmaceuticals,Inc.f9b4d18b-25f3-604f-e053-6394a90a55312025-02-10Warnings, Adverse reactionsExact identifier
unii: Q40Q9N063P
Eyesaline Eyewash ConcentratePURIFIED WATERHoneywell Safety Products, Inc.2d90c8e8-f479-3535-e063-6394a90af1222025-02-07WarningsExact identifier
unii: 059QF0KO0R
Code Red Eye Drops Redness ReliefPOLYETHYLENE GLYCOL 400, TETRAHYDROZOLINE HCL4 Trees, LLC0aa08018-cc2d-d947-e063-6394a90a914a2025-02-07WarningsExact identifier
unii: B697894SGQ
Bestmade Natural Products BM63CEANOTHUS, KALI MUR, KALI ARS, OOPHRINUM, SELENIUM, THALLIUM, WEISBADENBestmade Natural Products2cea4552-3700-3da3-e063-6294a90a14b52025-01-30WarningsExact identifier
unii: 059QF0KO0R
Endopan HPACETICUM ACIDUM, ALPHA-LIPOICUM ACIDUM, BRYONIA (ALBA), CHROMIUM, COLCHICUM AUTUMNALE, LACTICUM ACIDUM, LYCOPODIUM CLAVATUM, PHOSPHORICUM ACIDUM, PHOSPHORUS, SULPHUR, SYZYGIUM JAMBOLANUM, THUJA OCCIDENTALIS, URANIUM NITRICUMEnergique, Inc.2bc69a24-c24c-4d12-92bb-7c073edf90dc2025-01-24WarningsExact identifier
unii: Q40Q9N063P
Medics Choice Soothing Eye WashPURIFIED WATERKC Pharmaceuticals, Inc.10e49808-161e-f4ec-e063-6294a90a17752025-01-19WarningsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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