Label: DEX-MOXI-KETOR- dexamethasone phosphate - moxifloxacin - ketorolac tromethamine injection, solution
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Contains inactivated NDC Code(s)
NDC Code(s): 71384-513-01 - Packager: Imprimis NJOF, LLC
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
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Drug Label Information
Updated February 10, 2020
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INGREDIENTS AND APPEARANCE
DEX-MOXI-KETOR
dexamethasone phosphate - moxifloxacin - ketorolac tromethamine injection, solutionProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:71384-513 Route of Administration OPHTHALMIC Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DEXAMETHASONE SODIUM PHOSPHATE (UNII: AI9376Y64P) (DEXAMETHASONE - UNII:7S5I7G3JQL) DEXAMETHASONE PHOSPHATE 1 mg in 1 mL MOXIFLOXACIN HYDROCHLORIDE MONOHYDRATE (UNII: B8956S8609) (MOXIFLOXACIN - UNII:U188XYD42P) MOXIFLOXACIN 0.5 mg in 1 mL KETOROLAC TROMETHAMINE (UNII: 4EVE5946BQ) (KETOROLAC - UNII:YZI5105V0L) KETOROLAC 0.4 mg in 1 mL Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:71384-513-01 20 in 1 BOX 01/05/2018 1 1 mL in 1 VIAL, SINGLE-USE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 01/05/2018 Labeler - Imprimis NJOF, LLC (080431967) Registrant - Imprimis NJOF, LLC (080431967)