Triple Antibiotic

Product NDC
57319-343
11-digit product format
573190343
Labeler code
57319
Product ID
57319-343_f7504b22-2d9e-4e2c-a308-1469bd5a1bab
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Neomycin sulfate, Polymyxin B Sulfate and Bacitracin Zinc
Dosage form
OINTMENT
Route
OPHTHALMIC
Labeler
Phoenix Pharmaceutical, Inc.
Application
ANDA064064
Marketing category
ANDA
Marketing start
1995-10-30
Marketing end
0000-00-00
Substance
NEOMYCIN SULFATE; POLYMYXIN B SULFATE; BACITRACIN ZINC
Active strength
4 mg/g; [USP'U]/g; [USP'U]/g
Pharmacologic classes
Aminoglycoside Antibacterial [EPC],Aminoglycosides [CS],Polymyxin-class Antibacterial [EPC],Polymyxins [CS],Decreased Cell Wall Synthesis & Repair [PE]
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
99e684e6-f435-feb8-d2bb-3a546f1cb768Product name220161117
25340b3b-3e4c-4ff8-abf6-3e62ec46bd0cProduct name120160603
2d352c73-a357-4193-a4de-dfdf9a2ac8e4Product name120150819
b045ad64-0f28-9a02-2f9b-b34d94fb2278Product name120140508
b6082387-f592-1148-0844-bd068fd213fbProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
57319-343-252019-10-29C16284748780-1960f7f55-c5ab-8e05-e053-dbdaa90a074aNeomycin and Polymyxin B Sulfates and Bacitracin Zinc Ophthalmic Ointment USP (Sterile)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57319-343-25Triple Antibiotic1 in 1 CARTONOINTMENT11
57319-343-25Triple Antibiotic3.5 g in 1 TUBEOINTMENT3.51

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57319-343TRIPLE ANTIBIOTIC (NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND BACITRACIN ZINC) OINTMENT [PHOENIX PHARMACEUTICAL, INC.]1Legacy NDC, 2 package rows20101122_f7504b22-2d9e-4e2c-a308-1469bd5a1bab.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308493bacitracin zinc 400 UNT / neomycin sulfate 3.5 MG / polymyxin B sulfate 10,000 UNT per GM Ophthalmic OintmentPSNf7504b22-2d9e-4e2c-a308-1469bd5a1bab1
308493bacitracin 0.4 UNT/MG / neomycin 0.0035 MG/MG / polymyxin B 10 UNT/MG Ophthalmic OintmentSCDf7504b22-2d9e-4e2c-a308-1469bd5a1bab1
308493bacitracin 0.4 UNT/MG / neomycin 0.35 % / polymyxin B 10 UNT/MG Ophthalmic OintmentSYf7504b22-2d9e-4e2c-a308-1469bd5a1bab1
308493bacitracin 400 UNT / neomycin 3.5 MG / polymyxin B 10,000 UNT per GM Ophthalmic OintmentSYf7504b22-2d9e-4e2c-a308-1469bd5a1bab1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
57319-343-25573190343251 in 1 CARTONHistorical