NDC 71384-630

MKO Melt

Midazolaam - Ketamine Hcl - Ondansetron

MKO Melt is a Sublingual Troche in the Human Prescription Drug category. It is labeled and distributed by Imprimis Njof, Llc. The primary component is Midazolam; Ketamine Hydrochloride; Ondansetron Hydrochloride.

• Product ID: 71384-630_7cdebcbc-03dc-1669-e053-2991aa0a3cd6
• NDC: 71384-630
• Product Type: Human Prescription Drug
• Proprietary Name: MKO Melt
• Generic Name: Midazolaam - Ketamine Hcl - Ondansetron
• Dosage Form: Troche
• Route of Administration: SUBLINGUAL
• Marketing Start Date: 2018-12-01
• Marketing Category: UNAPPROVED DRUG OTHER / UNAPPROVED DRUG OTHER
• Labeler Name: Imprimis NJOF, LLC
• Substance Name: MIDAZOLAM; KETAMINE HYDROCHLORIDE; ONDANSETRON HYDROCHLORIDE
• Active Ingredient Strength: 3 mg/1; mg/1; mg/1
• Pharm Classes: Benzodiazepine [EPC],Benzodiazepines [CS],General Anesthesia [PE],General Anesthetic [EPC],Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC]
• DEA Schedule: CIII
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 71384-630-21

21 TROCHE in 1 BLISTER PACK (71384-630-21)

• Marketing Start Date: 2018-12-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 71384-630-21 [71384063021]

MKO Melt TROCHE

• Marketing Category: unapproved drug other
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2018-12-01
• Marketing End Date: 2019-03-04
• Inactivation Date: 2020-01-31
• Reactivation Date: 2020-02-10

Drug Details

Active Ingredients

Ingredient	Strength
MIDAZOLAM	3 mg/1

OpenFDA Data

• SPL SET ID: 7cdebcbc-03db-1669-e053-2991aa0a3cd6
• Manufacturer:
  • Imprimis NJOF, LLC
• UNII:
  • O18YUO0I83
  • NMH84OZK2B
  • R60L0SM5BC

Pharmacological Class

• Benzodiazepine [EPC]
• Benzodiazepines [CS]
• General Anesthesia [PE]
• General Anesthetic [EPC]
• Serotonin 3 Receptor Antagonists [MoA]
• Serotonin-3 Receptor Antagonist [EPC]