Label: PRED PHOS-GATI-BROM- prednisolone phosphate - gatifloxacin - bromfenac solution/ drops

  • NDC Code(s): 71384-550-03, 71384-550-07
  • Packager: Imprimis NJOF, LLC
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated June 7, 2018

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  • STORAGE AND HANDLING

    Store at 20° to 25° C (68° to 77° F)​

  • PRINCIPAL DISPLAY PANEL

    Bottle Label

  • INGREDIENTS AND APPEARANCE
    PRED PHOS-GATI-BROM 
    prednisolone phosphate - gatifloxacin - bromfenac solution/ drops
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:71384-550
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PREDNISOLONE SODIUM PHOSPHATE (UNII: IV021NXA9J) (PREDNISOLONE - UNII:9PHQ9Y1OLM) PREDNISOLONE 21-PHOSPHATE10 mg  in 1 mL
    GATIFLOXACIN (UNII: L4618BD7KJ) (GATIFLOXACIN ANHYDROUS - UNII:81485Y3A9A) GATIFLOXACIN5 mg  in 1 mL
    BROMFENAC (UNII: 864P0921DW) (BROMFENAC - UNII:864P0921DW) BROMFENAC0.75 mg  in 1 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71384-550-033.5 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product07/02/2018
    2NDC:71384-550-077 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product07/02/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other07/02/2018
    Labeler - Imprimis NJOF, LLC (080431967)