FDA.reportPublic FDA data

Dex-Moxi-Ketor

Manufacturer
Imprimis NJOF, LLC
Effective date
2020-02-10
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-05-31 20:32:16

Label at a glance#

ProductDex-Moxi-Ketor
Active ingredientDEXAMETHASONE SODIUM PHOSPHATE, MOXIFLOXACIN HYDROCHLORIDE MONOHYDRATE, KETOROLAC TROMETHAMINE
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
DEXAMETHASONE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
KETOROLAC Pharmacologic Class Indexing3Indexing - Pharmacologic Class20191108
MOXIFLOXACIN Pharmacologic Class Indexing3Indexing - Pharmacologic Class20230421

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
84b851da-be59-d750-14d1-e4d93cc3b4daProduct name920250630
1ea46721-9071-6b81-fd0a-a82bfbb014ecProduct name720250220
525701df-f985-480d-995a-e0ee70c2bdf4Product name520250128
6a38bd75-79e3-96c0-1204-08a0282902aeProduct name420250128
4d6e22a5-3693-6edf-0179-2ab93aecbadbProduct name920240724
ea50b939-d92a-4100-84f5-1c1089663837Product name220240705
2194a6ab-15bb-de49-cced-f09e642b1b64Product name820240313
03452e68-2506-686e-a908-f2381c778fc6Product name520240307
941f67d9-7f03-56d2-750c-36de24f654dbProduct name320221117
d7d46a10-8766-d3c8-ebf2-2ccd9efdcae8Product name220220506
7b2c58e8-5850-4e3e-82e9-b1593b1de761Product name520220210
81e34474-b0a5-434f-8104-25d689efc99eProduct name120200303
b5abe2e3-39a1-43eb-9bff-f3c1653fe3dfProduct name220190930
05ab9c01-cd9a-4f59-b2e8-ddcb887cac39Product name120190408
bb41bc3a-c643-93c9-055f-a8f48f363af3Product name220190219
0c7dba41-c919-5809-508d-4affe6cfcff2Product name220170817
d7840f4c-f22a-4403-b5da-53ac6ac8fd90Product name120150728
ccc7bb05-654a-45d2-a0d6-09ab96ba531bProduct name220150611
399647c0-db89-02d1-991c-0c17b584482cProduct name120140508
3e9a6377-704f-dff7-b19f-56c98d40c444Product name120140508
4d2e6ff9-14f5-b84f-c39b-373b005712c1Product name120140508
4f6a8082-ae1e-0ff7-4dc0-77f9f0f7b70cProduct name120140508
725d71bf-f956-5cad-e556-fa39cb060dc8Product name120140508
8d3e992f-8ff7-c106-f7eb-1e2d5eb12025Product name120140508
9ea85abb-fa68-5da6-ab60-2c7eef579000Product name120140508
d029211e-5e6b-725f-3696-ac6ff77da222Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71384-513-012022-01-28C16284748780-19d75b9d0-9544-f424-e053-dadaa90a57ce62fff769-95d6-0908-e053-2a91aa0a732d
71384-513-012020-02-10C16284748780-19d75b9d0-9544-f424-e053-dadaa90a57ce62fff769-95d6-0908-e053-2a91aa0a732d
71384-513-012020-01-31C16284748780-19d75b9d0-9544-f424-e053-dadaa90a57ce62fff769-95d6-0908-e053-2a91aa0a732d

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71384-513-01Dex-Moxi-Ketor20 in 1 BOXINJECTION, SOLUTION204
71384-513-01Dex-Moxi-Ketor1 mL in 1 VIAL, SINGLE-USEINJECTION, SOLUTION14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71384-513DEX-MOXI-KETOR (DEXAMETHASONE PHOSPHATE - MOXIFLOXACIN - KETOROLAC TROMETHAMINE) INJECTION, SOLUTION [IMPRIMIS NJOF, LLC]4Legacy NDC, 2 package rows20200211_62fff769-95d6-0908-e053-2a91aa0a732d.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71384-513-01ML - Milliliter71384-513d60a813e-52e2-43bc-8702-2fad2b1543a912018-07-03

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71384-51371384-513-01

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
DEXAMETHASONE SODIUM PHOSPHATEAI9376Y64PACTIR
MOXIFLOXACIN HYDROCHLORIDE MONOHYDRATEB8956S8609ACTIM
KETOROLAC TROMETHAMINE4EVE5946BQACTIM

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
9e3cfa4f-0cb8-728f-e053-2a95a90ab42662fff769-95d6-0908-e053-2a91aa0a732d2020-02-10Exact identifier
spl id: 9e3cfa4f-0cb8-728f-e053-2a95a90ab426
spl set id: 62fff769-95d6-0908-e053-2a91aa0a732d

Reported adverse events (FAERS/openFDA)#

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