PRED-BROM- prednisolone acetate-bromfenac suspension/ drops 
Imprimis NJOF, LLC

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.

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Store at 20° to 25° C (68° to 77° F)

Package Label

Package Label

PRED-BROM 
prednisolone acetate-bromfenac suspension/ drops
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:71384-505
Route of AdministrationOPHTHALMIC
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PREDNISOLONE ACETATE (UNII: 8B2807733D) (PREDNISOLONE - UNII:9PHQ9Y1OLM) PREDNISOLONE ACETATE10 mg  in 1 mL
BROMFENAC SODIUM (UNII: 8ECV571Y37) (BROMFENAC - UNII:864P0921DW) BROMFENAC0.75 mg  in 1 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71384-505-0320 in 1 BOX01/05/2018
13.5 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other01/05/2018
Labeler - Imprimis NJOF, LLC (080431967)

Revised: 1/2018
Document Id: 632b3f47-ae7c-3e64-e053-2991aa0a59f9
Set id: 63254869-67d5-0900-e053-2a91aa0af95c
Version: 2
Effective Time: 20180119
 
Imprimis NJOF, LLC