Neomycin and Polymyxin B Sulfates and Dexamethasone

Product NDC
33261-551
11-digit product format
332610551
Labeler code
33261
Product ID
33261-551_4a99000d-0a00-47dd-a82e-9a20f89b60af
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
neomycin sulfate, polymyxin b sulfate and dexamethasone
Dosage form
SUSPENSION
Route
OPHTHALMIC
Labeler
Aidarex Pharmaceuticals LLC
Application
ANDA062341
Marketing category
ANDA
Marketing start
2017-11-13
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
2019-12-31
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
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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
33261-551-012020-01-31C16284748780-19d75b9d0-3634-f424-e053-dadaa90a57ceNeomycin and Polymyxin B Sulfates and Dexamethasone Ophthalmic Suspension Sterile

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
33261-551-01Neomycin and Polymyxin B Sulfates and Dexamethasone5 mL in 1 BOTTLE, PLASTICSUSPENSION51

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
33261-551NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE (NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND DEXAMETHASONE) SUSPENSION [AIDAREX PHARMACEUTICALS LLC]1Legacy NDC, 1 package rows20180814_7b18587e-2d50-453c-8521-fb0c4fe51611.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 SuspensionPSN7b18587e-2d50-453c-8521-fb0c4fe516111
309680dexamethasone 1 MG/ML / neomycin 3.5 MG/ML / polymyxin B 10000 UNT/ML Ophthalmic SuspensionSCD7b18587e-2d50-453c-8521-fb0c4fe516111
309680dexamethasone 0.1 % / neomycin 0.35 % / polymyxin B 10,000 UNT per ML Ophthalmic SuspensionSY7b18587e-2d50-453c-8521-fb0c4fe516111

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
33261-551-01332610551015 mL in 1 BOTTLE, PLASTIC5 mlHistorical