FDA.reportPublic FDA data

MKO Melt Dose Pack

Manufacturer
Imprimis NJOF, LLC
Effective date
2019-03-04
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 20:27:57

Label at a glance#

ProductMKO Melt Dose Pack
Active ingredientMIDAZOLAM, KETAMINE HYDROCHLORIDE, ONDANSETRON HYDROCHLORIDE ANHYDROUS
Label structure2 sections

Storage and handling

Store at 20° to 25° C (68° to 77° F)

Label contents#

Full prescribing information#

Storage and Handling

STORAGE AND HANDLING SECTION

Store at 20° to 25° C (68° to 77° F)

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Product LabelProduct Label

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
KETAMINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
MIDAZOLAM Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
ONDANSETRON 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
d9bd4853-037c-6968-f4d4-9bb9a0efd1eaProduct name220250722
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
32e23bc9-ce14-4555-bb6d-bcb654d7d296Product name120201015
e459f50a-1553-4aab-b6bd-1e5f0c211c49Product name120201015
b84efe2b-3f4e-4b09-90f9-1d24a61ec30eProduct name120190808
bb7f99f4-8b2b-42a4-8f5a-fcf7dc204f16Product name120181220
909480fe-0d18-c1c1-a658-0bd9a7131822Product name520170829
31f18c4e-1938-700a-43de-b9e218c36edcProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71384-410-032021-01-29C16284748780-1ba0f9c33-57cf-a910-e053-dadaa90a0b8583491310-f848-ce3d-e053-2a91aa0aa906

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71384-410-03MKO Melt Dose Pack3 in 1 DOSE PACKTROCHE31

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71384-410MKO MELT DOSE PACK (MIDAZOLAM - KETAMINE HCL - ONDANSETRON) TROCHE [IMPRIMIS NJOF, LLC]1Legacy NDC, 1 package rows20190306_83491310-f848-ce3d-e053-2a91aa0aa906.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71384-410-03EA - Each71384-4105bc54775-c70f-49a4-9438-754e9c27bf6712019-11-12

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
71384-41071384-410-03

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
MIDAZOLAMR60L0SM5BCACTIB
KETAMINE HYDROCHLORIDEO18YUO0I83ACTIM
ONDANSETRON HYDROCHLORIDE ANHYDROUS2999F27MADACTIM

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
83491310-f849-ce3d-e053-2a91aa0aa90683491310-f848-ce3d-e053-2a91aa0aa9062019-03-04Exact identifier
spl id: 83491310-f849-ce3d-e053-2a91aa0aa906
spl set id: 83491310-f848-ce3d-e053-2a91aa0aa906

Reported adverse events (FAERS/openFDA)#

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