FDA.reportPublic FDA data

ReadyfusOR Ropivacaine

Manufacturer
BioQ Pharma Incorporated | Holopack Verpackungstechnik (DE) | Steris AST (Frmrly Synergy San Diego) | Steris AST (Frmrly Synergy Daventry ) | A&M Stabtest (Mainz, DE) | Pioneer Agro Industries
Effective date
2018-06-22
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 20:25:56

Label at a glance#

ProductReadyfusOR Ropivacaine Fixed Rate Delivery System
Active ingredientROPIVACAINE HYDROCHLORIDE ANHYDROUS
Label structure1 sections

Label contents#

Full prescribing information#

PRINCIPAL DISPLAY PANEL - 250 mL Bottle Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

GALEN
Distributed by:
Galen Limited
Craigavon
BT63 5UA
UK

Ropivacaine
ReadyfusOR™
Infusion pump

Ropivacaine 2 mg/ml Solution for Infusion in Administration System

Ropivacaine Hydrochloride
250 ml
5 ml/hr

PRINCIPAL DISPLAY PANEL - 250 mL Bottle Carton
PRINCIPAL DISPLAY PANEL - 250 mL Bottle Carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1734205ropivacaine hydrochloride 2 MG/ML InjectionSCD1

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
ROPIVACAINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
387afa15-cb51-403a-b2e2-1c9d201e07dcProduct name920230426

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71807-011-012020-01-31C16284748780-19d75b9d0-255a-f424-e053-dadaa90a57ceRopivacaine

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71807-011-01ReadyfusOR RopivacaineFixed Rate Delivery System250 mL in 1 BOTTLE, DISPENSINGINJECTION, SOLUTION2501
71807-011-01ReadyfusOR RopivacaineFixed Rate Delivery System1 in 1 BOXINJECTION, SOLUTION11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71807-011READYFUSOR ROPIVACAINE FIXED RATE DELIVERY SYSTEM (ROPIVACAINE HYDROCHLORIDE ANHYDROUS) INJECTION, SOLUTION [BIOQ PHARMA INCORPORATED]12 package rows20180627_f3981363-109c-4e3a-aed3-3e18e4c13eb6.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71807-01171807-011-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
NameUNIIKind
ROPIVACAINE HYDROCHLORIDE ANHYDROUS35504LBE2TACTIB
SODIUM CHLORIDE451W47IQ8XIACT
WATER059QF0KO0RIACT
HYDROCHLORIC ACIDQTT17582CBIACT
SODIUM HYDROXIDE55X04QC32IIACT

Source Document#

Source XML · Source PDF

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 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
5febbbcb-ef1f-4e6c-b2d3-a7436e4d5b00f3981363-109c-4e3a-aed3-3e18e4c13eb62018-06-22Exact identifier
spl id: 5febbbcb-ef1f-4e6c-b2d3-a7436e4d5b00
spl set id: f3981363-109c-4e3a-aed3-3e18e4c13eb6

Reported adverse events (FAERS/openFDA)#

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