NDC 71384-420 Mkh Dose Pack

Midazolam - Ketamine Hcl - Hydroxyzine Hcl

NDC Product Code 71384-420

NDC 71384-420-03

Package Description: 3 TROCHE in 1 DOSE PACK

NDC Product Information

Mkh Dose Pack with NDC 71384-420 is a a human prescription drug product labeled by Imprimis Njof, Llc. The generic name of Mkh Dose Pack is midazolam - ketamine hcl - hydroxyzine hcl. The product's dosage form is troche and is administered via sublingual form.

Labeler Name: Imprimis Njof, Llc

Dosage Form: Troche - A discoid-shaped solid containing the medicinal agent in a suitably flavored base; troches are placed in the mouth where they slowly dissolve, liberating the active ingredients.

Product Type: Human Prescription Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

DEA Schedule: Schedule III (CIII) Substances What is the Drug Enforcement Administration (DEA) CIII Schedule?
The controlled substances in the CIII schedule have an abuse potential and dependence liability less than those in schedules CI and CII, and have an accepted medical use in the United States. Schedule CIII controlled substances include preparations containing limited quantities of certain narcotic drugs, and other nonnarcotic drugs such as: derivatives of barbituric acid, except those that are listed in another schedule, glutethimide (Doriden), methyprylon (Noludar), nalorphine, benzphetamine, chlorphentermine, clortermine, and phendimetrazine.


Mkh Dose Pack Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • KETAMINE HYDROCHLORIDE 25 mg/1
  • MIDAZOLAM 3 mg/1
  • HYDROXYZINE HYDROCHLORIDE 10 mg/1

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Sublingual - Administration beneath the tongue.

Pharmacological Class(es)

What is a Pharmacological Class?
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

  • General Anesthesia - [PE] (Physiologic Effect)
  • General Anesthetic - [EPC] (Established Pharmacologic Class)
  • Benzodiazepine - [EPC] (Established Pharmacologic Class)
  • Benzodiazepines - [CS]
  • Antihistamine - [EPC] (Established Pharmacologic Class)
  • Histamine Receptor Antagonists - [MoA] (Mechanism of Action)

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

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Mkh Dose Pack Product Label Images

Mkh Dose Pack Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Storage And Handling

Store at 20° to 25° C (68° to 77° F)

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