FDA.reportPublic FDA data

MKH Dose Pack

Manufacturer
Imprimis NJOF, LLC
Effective date
2019-03-05
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 20:27:58

Label at a glance#

ProductMKH Dose Pack
Active ingredientKETAMINE HYDROCHLORIDE, MIDAZOLAM, HYDROXYZINE HYDROCHLORIDE
Label structure2 sections

Storage and handling

Store at 20° to 25° C (68° to 77° F)

Label contents#

Full prescribing information#

STORAGE AND HANDLING SECTION

Store at 20° to 25° C (68° to 77° F)

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Package LabelPackage Label

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
HYDROXYZINE Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813
KETAMINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
MIDAZOLAM Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
1d526338-43ba-4cef-8730-5a757122f8ceProduct name120260218
8118475d-d61b-4326-b353-56e9cf8c8d9fProduct name320260218
57311cfb-679a-da1a-b70c-8757f7fc431aProduct name420250516
f69f3735-bf62-03e6-cc7a-5af4af89ec8aProduct name520250516
bb4bf50b-0475-bcb2-86ff-7b0cc2cc55bcProduct name220240223
4cc03496-da49-494d-b71d-757fe6737fa2Product name120230717
06641162-4d53-492d-8ff2-5951a469060fProduct name120230420
46ca420c-e4d5-4e6c-9b2f-cea269a262e8Product name120230320
b84efe2b-3f4e-4b09-90f9-1d24a61ec30eProduct name120190808
aa1826f4-97c1-4705-bdf0-3bc7d234e618Product name220190618
bb7f99f4-8b2b-42a4-8f5a-fcf7dc204f16Product name120181220
75cb12ee-8eb2-4f1a-a332-5743a5d0da41Product name120151110
31f18c4e-1938-700a-43de-b9e218c36edcProduct name120140508
3ca5f78b-43dc-30fe-8014-55b922af52b3Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71384-420-032021-01-29C16284748780-1ba0f9c33-4d15-a910-e053-dadaa90a0b85835ea393-6860-5875-e053-2a91aa0ac9c2

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71384-420-03MKH Dose Pack3 in 1 DOSE PACKTROCHE31

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71384-420MKH DOSE PACK (MIDAZOLAM - KETAMINE HCL - HYDROXYZINE HCL) TROCHE [IMPRIMIS NJOF, LLC]1Legacy NDC, 1 package rows20190306_835ea393-6860-5875-e053-2a91aa0ac9c2.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71384-42071384-420-03

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Name, UNII, Kind table
NameUNIIKind
KETAMINE HYDROCHLORIDEO18YUO0I83ACTIM
MIDAZOLAMR60L0SM5BCACTIB
HYDROXYZINE HYDROCHLORIDE76755771U3ACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
835ea393-6861-5875-e053-2a91aa0ac9c2835ea393-6860-5875-e053-2a91aa0ac9c22019-03-05Exact identifier
spl id: 835ea393-6861-5875-e053-2a91aa0ac9c2
spl set id: 835ea393-6860-5875-e053-2a91aa0ac9c2

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.