Label: READYFUSOR ROPIVACAINE FIXED RATE DELIVERY SYSTEM- ropivacaine hydrochloride anhydrous injection, solution
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Contains inactivated NDC Code(s)
NDC Code(s): 71807-011-01 - Packager: BioQ Pharma Incorporated
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: Export only
Drug Label Information
Updated June 22, 2018
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- PRINCIPAL DISPLAY PANEL - 250 mL Bottle Carton
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INGREDIENTS AND APPEARANCE
READYFUSOR ROPIVACAINE FIXED RATE DELIVERY SYSTEM
ropivacaine hydrochloride anhydrous injection, solutionProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:71807-011 Route of Administration INFILTRATION Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ROPIVACAINE HYDROCHLORIDE ANHYDROUS (UNII: 35504LBE2T) (ROPIVACAINE - UNII:7IO5LYA57N) ROPIVACAINE HYDROCHLORIDE ANHYDROUS 2 mg in 1 mL Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) WATER (UNII: 059QF0KO0R) HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I) Product Characteristics Color ORANGE Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:71807-011-01 1 in 1 BOX 03/05/2018 1 250 mL in 1 BOTTLE, DISPENSING; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.) Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date EXPORT ONLY 03/05/2018 Labeler - BioQ Pharma Incorporated (783975480) Establishment Name Address ID/FEI Business Operations Holopack Verpackungstechnik (DE) 343390324 MANUFACTURE(71807-011) Establishment Name Address ID/FEI Business Operations Steris AST (Frmrly Synergy San Diego) 173008660 STERILIZE(71807-011) Establishment Name Address ID/FEI Business Operations Steris AST (Frmrly Synergy Daventry ) 214479987 STERILIZE(71807-011) Establishment Name Address ID/FEI Business Operations A&M Stabtest (Mainz, DE) 341843679 ANALYSIS(71807-011) Establishment Name Address ID/FEI Business Operations Pioneer Agro Industries 677604359 API MANUFACTURE(71807-011)
