NDC | 71384-420-03 |
Set ID | 835ea393-6860-5875-e053-2a91aa0ac9c2 |
Category | HUMAN PRESCRIPTION DRUG LABEL |
Packager | Imprimis NJOF, LLC |
Generic Name | |
Product Class | Antihistamine, Benzodiazepine |
Product Number | |
Application Number |
- STORAGE AND HANDLING
- Package Label
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INGREDIENTS AND APPEARANCE
MKH DOSE PACK
midazolam - ketamine hcl - hydroxyzine hcl trocheProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:71384-420 Route of Administration SUBLINGUAL DEA Schedule CIII Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength KETAMINE HYDROCHLORIDE (UNII: O18YUO0I83) (KETAMINE - UNII:690G0D6V8H) KETAMINE 25 mg MIDAZOLAM (UNII: R60L0SM5BC) (MIDAZOLAM - UNII:R60L0SM5BC) MIDAZOLAM 3 mg HYDROXYZINE HYDROCHLORIDE (UNII: 76755771U3) (HYDROXYZINE - UNII:30S50YM8OG) HYDROXYZINE HYDROCHLORIDE 10 mg Product Characteristics Color white (Off White) Score no score Shape ROUND Size 8mm Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:71384-420-03 3 in 1 DOSE PACK; Type 0: Not a Combination Product 03/04/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 03/04/2019 Labeler - Imprimis NJOF, LLC (080431967) Registrant - Imprimis NJOF, LLC (080432967)