FDA.reportPublic FDA data

Neomycin Polymyxin B Sulfates and Dexamethasone

Product NDC
45865-796
11-digit product format
458650796
Labeler code
45865
Product ID
45865-796_7df0c910-93ce-65a6-e053-2991aa0aeb4c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Neomycin sulfate, Polymyxin B Sulfate and Dexamethasone
Dosage form
SUSPENSION/ DROPS
Route
OPHTHALMIC
Labeler
medsource pharmaceuticals
Application
ANDA064135
Marketing category
ANDA
Marketing start
1995-09-13
Marketing end
0000-00-00
Substance
NEOMYCIN SULFATE; POLYMYXIN B SULFATE; DEXAMETHASONE
Active strength
4 mg/mL; [USP'U]/mL; mg/mL
Pharmacologic classes
Aminoglycoside Antibacterial [EPC],Aminoglycosides [CS],Polymyxin-class Antibacterial [EPC],Polymyxins [CS],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
1ea46721-9071-6b81-fd0a-a82bfbb014ecProduct name720250220
525701df-f985-480d-995a-e0ee70c2bdf4Product name520250128
ea50b939-d92a-4100-84f5-1c1089663837Product name220240705
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
99e684e6-f435-feb8-d2bb-3a546f1cb768Product name220161117
25340b3b-3e4c-4ff8-abf6-3e62ec46bd0cProduct name120160603
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
b045ad64-0f28-9a02-2f9b-b34d94fb2278Product name120140508
b6082387-f592-1148-0844-bd068fd213fbProduct name120140508
d029211e-5e6b-725f-3696-ac6ff77da222Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
45865-796-012025-01-30C16284748780-12cef2736-7473-d83d-e063-dadaa90ab31fNeomycin and Polymyxin B Sulfates and Dexamethasone Ophthalmic Suspension, USP (Sterile)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
45865-796-01Neomycin Polymyxin B Sulfates and Dexamethasone1 in 1 CARTONSUSPENSION/ DROPS11
45865-796-01Neomycin Polymyxin B Sulfates and Dexamethasone5 mL in 1 BOTTLE, DROPPERSUSPENSION/ DROPS51

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
45865-796NEOMYCIN POLYMYXIN B SULFATES AND DEXAMETHASONE (NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND DEXAMETHASONE) SUSPENSION/ DROPS [MEDSOURCE PHARMACEUTICALS]1Legacy NDC, 2 package rows20181227_7df0c910-93cd-65a6-e053-2991aa0aeb4c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309680neomycin sulfate 3.5 MG/ML / polymyxin B sulfate 10,000 UNT/mL / dexAMETHasone 0.1 % Ophthalmic SuspensionPSN7df0c910-93cd-65a6-e053-2991aa0aeb4c1
309680dexamethasone 1 MG/ML / neomycin 3.5 MG/ML / polymyxin B 10000 UNT/ML Ophthalmic SuspensionSCD7df0c910-93cd-65a6-e053-2991aa0aeb4c1
309680dexamethasone 0.1 % / neomycin 0.35 % / polymyxin B 10,000 UNT per ML Ophthalmic SuspensionSY7df0c910-93cd-65a6-e053-2991aa0aeb4c1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
45865-796-01458650796011 BOTTLE, DROPPER in 1 CARTON (45865-796-01) > 5 mL in 1 BOTTLE, DROPPER2018-06-010000-00-00NoNoCurrent