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 8 of 20 · 385 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Walgreens Ultra LubricantPOLYETHYLENE GLYCOL 400, AND PROPYLENE GLYCOLWalgreens21dfe061-4533-2061-e063-6394a90a6e732025-10-17WarningsExact identifier
unii: B697894SGQ
Xpect EyewashEYEWASHCintas Corporation1d69365d-662b-4248-8fa9-1629451b549a2025-09-30WarningsExact identifier
unii: 059QF0KO0R
CheBoho TEA TREE ACNECHEBOHO TEA TREE ACNEOpalshi(Guangzhou)E-commerce Co. Ltd.3fc4cf84-b2da-c593-e063-6394a90abc5c2025-09-27WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERProPharma Distribution3f2ae880-852f-b45d-e063-6394a90aa1cc2025-09-19Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
PerikabivenDEXTROSE, SOYBEAN OIL, ELECTROLYTES, LYSINE, PHENYLALANINE, LEUCINE, VALINE, THREONINE, METHIONINE, ISOLEUCINE, TRYPTOPHAN, ALANINE, ARGININE, GLYCINE, PROLINE, HISTIDINE, GLUTAMIC ACID, SERINE, ASPARTIC ACID AND TYROSINEFresenius Kabi USA, LLCc2eb5522-8572-45f4-869d-42f9fd251bb62025-09-15Warnings, Adverse reactionsExact identifier
unii: 4550K0SC9B
Dry eye reliefPOLYETHYLENE GLYCOL AND PROPYLENE GLYCOLCARDINAL HEALTH 110, LLC. DBA LEADERf8da3af5-9172-4023-be82-0fd5bd8916162025-09-12WarningsExact identifier
unii: B697894SGQ
KabivenDEXTROSE, SOYBEAN OIL, ELECTROLYTES, LYSINE, PHENYLALANINE, LEUCINE, VALINE, THREONINE, METHIONINE, ISOLEUCINE, TRYPTOPHAN, ALANINE, ARGININE, GLYCINE, PROLINE, HISTIDINE, GLUTAMIC ACID, SERINE, ASPARTIC ACID AND TYROSINEFresenius Kabi USA, LLCafeb4837-a759-4484-a76e-e04611c459e72025-09-11Warnings, Adverse reactionsExact identifier
unii: 4550K0SC9B
bivalirudinBIVALIRUDINCivica, Inc.19a4afc5-151d-4d3c-bfef-48aa8797d6952025-09-10Warnings, Adverse reactionsExact identifier
unii: TN9BEX005G
Medi-First First Aid Eye WashPURIFIED WATERUnifirst First Aid Corporationdcd7fe56-ff5c-4c8d-a415-6e363d7e53f42025-09-08WarningsExact identifier
unii: 059QF0KO0R
Green Guard First Aid Eye WashWATERUnifirst First Aid Corporationa4ba5526-b4e2-4bcc-9127-aa22ebf5017f2025-09-08WarningsExact identifier
unii: 059QF0KO0R
Medi-First Plus First Aid Eye WashWATERUnifirst First Aid Corporationd7ea80ca-b4a0-4476-8b50-b3425c6d456a2025-09-08WarningsExact identifier
unii: 059QF0KO0R
ECOLAB Eye WashPURIFIED WATERECOLAB Food Safety Specialties, Inc.4bcfa21a-791e-4d04-e054-00144ff88e882025-09-08WarningsExact identifier
unii: 059QF0KO0R
Physicians Care EyewashEYEWASHAcme United Corporation3e239b12-9a75-339d-e063-6294a90a72ae2025-09-06WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATER INJECTIONHenry Schein, Inc.3501952b-b556-4d5e-b81b-5c35ff87b4752025-08-28Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
BivalirudinBIVALIRUDINFresenius Kabi USA, LLC50975be1-6d1f-497c-b989-1825a0fae1a72025-08-27Warnings, Adverse reactionsExact identifier
unii: TN9BEX005G
Systane UltraPOLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOLAlcon Laboratories, Inc.0537c23a-15f7-be64-1231-a6c93468e9a82025-07-30WarningsExact identifier
unii: B697894SGQ
SystanePOLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOLAlcon Laboratories, Inc.1d679d0f-cec2-a644-79cd-079607254bb92025-07-30WarningsExact identifier
unii: B697894SGQ
Systane Ultra Preservative FreePOLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOLAlcon Laboratories, Inc.751fb85f-6683-4b0a-a650-324d4a74c5de2025-07-30WarningsExact identifier
unii: B697894SGQ
Aller-Chord FACETALDEHYDE, ACETICUM AC, ARG NIT, CAFFEINUM, CALC SULPH, CITRICUM AC, CORTISONE ACETICUM, ECHINACEA PURP, FOLLICULINUM, FRAGARIA, FUMARICUM AC, GALLICUM AC, GLANDULA SUPRARENALIS SUIS, HEPAR SUIS, HISTAMINUM HYDROCHLORICUM, HYDRANGEA, LAC VAC, LECITHIN, LIMULUS, LYCOPERSICUM, LYCOPODIUM, NAT BICARB, NAT MUR, NUX VOM, PARAFFINUM, PHOSPHORICUM AC, SACCHARUM OFF, SILICEA, TARTARICUM AC, TORULA CEREVISIAE.Energetix Corporationff4eb7b2-8272-4bd3-99a9-7e589b30d59a2025-07-15WarningsExact identifier
unii: Q40Q9N063P
DENTAL-CHORDACETICUM ACIDUM, AMMONIUM MURIATICUM, ARGENTUM METALLICUM, AURUM METALLICUM, CALCAREA FLUORICA, CALCAREA PHOSPHORICA, CARBOLICUM ACIDUM, CITRUS LIMONUM, CUPRUM METALLICUM, FERRUM METALLICUM, GLYCYRRHIZA GLABRA, LAPPA MAJOR, MEDULLA OSSIS SUIS, MERCURIUS SOLUBILIS, MYRRHA, NATRUM FLUORATUM, PALLADIUM METALLICUM, PHOSPHORICUM ACIDUM, PHYTOLACCA DECANDRA, SELENIUM METALLICUM, SILICEA, STANNUM METALLICUM, STAPHYSAGRIA, STILLINGIA SYLVATICA, TRIFOLIUM PRATENSE, X-RAY, ZINCUM OXYDATUMEnergetix Corporation6c9ba926-7c35-49fd-94d8-988ca0bb772c2025-07-15WarningsExact identifier
unii: Q40Q9N063P

Reported adverse events (FAERS/openFDA)#

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