Label: FENTANYL CITRATE, BUPIVACAINE HCL injection, solution
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Contains inactivated NDC Code(s)
NDC Code(s): 52533-080-61 - Packager: Cantrell Drug Company
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: CII
- Marketing Status: unapproved drug other
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Drug Label Information
Updated August 13, 2014
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INGREDIENTS AND APPEARANCE
FENTANYL CITRATE, BUPIVACAINE HCL
fentanyl citrate, bupivacaine hcl injection, solutionProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:52533-080 Route of Administration EPIDURAL DEA Schedule CII Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Fentanyl Citrate (UNII: MUN5LYG46H) (Fentanyl - UNII:UF599785JZ) Fentanyl 2 ug in 1 mL BUPIVACAINE HYDROCHLORIDE (UNII: 7TQO7W3VT8) (BUPIVACAINE - UNII:Y8335394RO) BUPIVACAINE HYDROCHLORIDE ANHYDROUS 1.25 mg in 1 mL Inactive Ingredients Ingredient Name Strength Sodium Chloride (UNII: 451W47IQ8X) 9 mg in 1 mL Water (UNII: 059QF0KO0R) Other Ingredients Ingredient Kind Ingredient Name Quantity May contain HYDROCHLORIC ACID (UNII: QTT17582CB) May contain SODIUM HYDROXIDE (UNII: 55X04QC32I) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:52533-080-61 250 mL in 1 BAG Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 08/16/2012 Labeler - Cantrell Drug Company (035545763)
