FDA.reportPublic FDA data

Dex-Moxi

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
Active ingredientDEXAMETHASONE SODIUM PHOSPHATE, MOXIFLOXACIN HYDROCHLORIDE MONOHYDRATE
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)

Vial Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Vial LabelVial Label

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DEXAMETHASONE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
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
ea50b939-d92a-4100-84f5-1c1089663837Product name220240705
2194a6ab-15bb-de49-cced-f09e642b1b64Product name820240313
941f67d9-7f03-56d2-750c-36de24f654dbProduct name320221117
d7d46a10-8766-d3c8-ebf2-2ccd9efdcae8Product name220220506
7b2c58e8-5850-4e3e-82e9-b1593b1de761Product name520220210
81e34474-b0a5-434f-8104-25d689efc99eProduct name120200303
05ab9c01-cd9a-4f59-b2e8-ddcb887cac39Product name120190408
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
725d71bf-f956-5cad-e556-fa39cb060dc8Product 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
71384-512-012022-01-28C16284748780-19d75b9cf-e555-f424-e053-dadaa90a57ce62ff1da3-7998-676a-e053-2991aa0a4a9f
71384-512-012020-02-10C16284748780-19d75b9cf-e555-f424-e053-dadaa90a57ce62ff1da3-7998-676a-e053-2991aa0a4a9f
71384-512-012020-01-31C16284748780-19d75b9cf-e555-f424-e053-dadaa90a57ce62ff1da3-7998-676a-e053-2991aa0a4a9f

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71384-512-01Dex-Moxi1 mL in 1 VIAL, SINGLE-USEINJECTION, SOLUTION14
71384-512-01Dex-Moxi20 in 1 BOXINJECTION, SOLUTION204

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71384-512DEX-MOXI (DEXAMETHASONE PHOSPHATE - MOXIFLOXACIN) INJECTION, SOLUTION [IMPRIMIS NJOF, LLC]4Legacy NDC, 2 package rows20200211_62ff1da3-7998-676a-e053-2991aa0a4a9f.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71384-512-01ML - Milliliter71384-512487c8a89-c160-4ec8-b98e-4b7a0f173daa12018-07-03

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
71384-51271384-512-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
NameUNIIKind
DEXAMETHASONE SODIUM PHOSPHATEAI9376Y64PACTIR
MOXIFLOXACIN HYDROCHLORIDE MONOHYDRATEB8956S8609ACTIB

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
9e3f348b-d46a-6ff1-e053-2995a90a7c1c62ff1da3-7998-676a-e053-2991aa0a4a9f2020-02-10Exact identifier
spl id: 9e3f348b-d46a-6ff1-e053-2995a90a7c1c
spl set id: 62ff1da3-7998-676a-e053-2991aa0a4a9f

Reported adverse events (FAERS/openFDA)#

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