NDC 71384-420

MKH Dose Pack

Midazolam - Ketamine Hcl - Hydroxyzine Hcl

MKH Dose Pack is a Sublingual Troche in the Human Prescription Drug category. It is labeled and distributed by Imprimis Njof, Llc. The primary component is Ketamine Hydrochloride; Midazolam; Hydroxyzine Hydrochloride.

• Product ID: 71384-420_835ea393-6861-5875-e053-2a91aa0ac9c2
• NDC: 71384-420
• Product Type: Human Prescription Drug
• Proprietary Name: MKH Dose Pack
• Generic Name: Midazolam - Ketamine Hcl - Hydroxyzine Hcl
• Dosage Form: Troche
• Route of Administration: SUBLINGUAL
• Marketing Start Date: 2019-03-04
• Marketing Category: UNAPPROVED DRUG OTHER / UNAPPROVED DRUG OTHER
• Labeler Name: Imprimis NJOF, LLC
• Substance Name: KETAMINE HYDROCHLORIDE; MIDAZOLAM; HYDROXYZINE HYDROCHLORIDE
• Active Ingredient Strength: 25 mg/1; mg/1; mg/1
• Pharm Classes: General Anesthesia [PE],General Anesthetic [EPC],Benzodiazepine [EPC],Benzodiazepines [CS],Antihistamine [EPC],Histamine Receptor Antagonists [MoA]
• DEA Schedule: CIII
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 71384-420-03

3 TROCHE in 1 DOSE PACK (71384-420-03)

• Marketing Start Date: 2019-03-04
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 71384-420-03 [71384042003]

MKH Dose Pack TROCHE

• Marketing Category: unapproved drug other
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2019-03-04

Drug Details

Active Ingredients

Ingredient	Strength
KETAMINE HYDROCHLORIDE	25 mg/1

OpenFDA Data

• SPL SET ID: 835ea393-6860-5875-e053-2a91aa0ac9c2
• Manufacturer:
  • Imprimis NJOF, LLC
• UNII:
  • O18YUO0I83
  • R60L0SM5BC
  • 76755771U3

Pharmacological Class

• General Anesthesia [PE]
• General Anesthetic [EPC]
• Benzodiazepine [EPC]
• Benzodiazepines [CS]
• Antihistamine [EPC]
• Histamine Receptor Antagonists [MoA]
• General Anesthesia [PE]
• General Anesthetic [EPC]
• Benzodiazepine [EPC]
• Benzodiazepines [CS]
• Antihistamine [EPC]
• Histamine Receptor Antagonists [MoA]