MKH DOSE PACK- midazolam - ketamine hcl - hydroxyzine hcl troche 
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

MKH DOSE PACK 
midazolam - ketamine hcl - hydroxyzine hcl troche
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:71384-420
Route of AdministrationSUBLINGUALDEA ScheduleCIII    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
KETAMINE HYDROCHLORIDE (UNII: O18YUO0I83) (KETAMINE - UNII:690G0D6V8H) KETAMINE25 mg
MIDAZOLAM (UNII: R60L0SM5BC) (MIDAZOLAM - UNII:R60L0SM5BC) MIDAZOLAM3 mg
HYDROXYZINE HYDROCHLORIDE (UNII: 76755771U3) (HYDROXYZINE - UNII:30S50YM8OG) HYDROXYZINE HYDROCHLORIDE10 mg
Product Characteristics
Colorwhite (Off White) Scoreno score
ShapeROUNDSize8mm
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71384-420-033 in 1 DOSE PACK; Type 0: Not a Combination Product03/04/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other03/04/2019
Labeler - Imprimis NJOF, LLC (080431967)
Registrant - Imprimis NJOF, LLC (080432967)

Revised: 3/2019
Document Id: 835ea393-6861-5875-e053-2a91aa0ac9c2
Set id: 835ea393-6860-5875-e053-2a91aa0ac9c2
Version: 1
Effective Time: 20190305
 
Imprimis NJOF, LLC