Neomycin and Polymyxin B Sulfates, and Bacitracin Zinc

Product NDC
13985-607
11-digit product format
139850607
Labeler code
13985
Product ID
13985-607_95de95d4-4393-4a34-a9c7-63169e112f85
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Neomycin Sulfate, Polymyxin B Sulfate and Bacitracin Zinc
Dosage form
OINTMENT
Route
OPHTHALMIC
Labeler
MWI
Application
ANDA065088
Marketing category
ANDA
Marketing start
2015-03-23
Marketing end
0000-00-00
Substance
BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE
Active strength
400 [USP'U]/g; mg/g; [USP'U]/g
Pharmacologic classes
Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]
NDC exclude flag
No
Listing certified through
2023-12-31
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
13985-607-032024-01-30C16284748780-11030e365-463a-111a-e063-dadaa90a10e2apexa™ Neomycin and Polymyxin B Sulfates and Bacitracin Zinc Ophthalmic Ointment, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
13985-607-03Neomycin and Polymyxin B Sulfates, and Bacitracin Zinc3.5 g in 1 TUBEOINTMENT3.54
13985-607-03Neomycin and Polymyxin B Sulfates, and Bacitracin Zinc1 in 1 CARTONOINTMENT14

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
13985-607NEOMYCIN AND POLYMYXIN B SULFATES, AND BACITRACIN ZINC (NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND BACITRACIN ZINC) OINTMENT [MWI]4Legacy NDC, 2 package rows20220203_0f651b47-ef7e-4d07-b3b1-8baade8b9031.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 OintmentPSN0f651b47-ef7e-4d07-b3b1-8baade8b90314
308493bacitracin 0.4 UNT/MG / neomycin 0.0035 MG/MG / polymyxin B 10 UNT/MG Ophthalmic OintmentSCD0f651b47-ef7e-4d07-b3b1-8baade8b90314
308493bacitracin 0.4 UNT/MG / neomycin 0.35 % / polymyxin B 10 UNT/MG Ophthalmic OintmentSY0f651b47-ef7e-4d07-b3b1-8baade8b90314
308493bacitracin 400 UNT / neomycin 3.5 MG / polymyxin B 10,000 UNT per GM Ophthalmic OintmentSY0f651b47-ef7e-4d07-b3b1-8baade8b90314

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
13985-607-03139850607031 TUBE in 1 CARTON (13985-607-03) > 3.5 g in 1 TUBE1 tube2015-03-230000-00-00NoNoCurrent