FDA.reportPublic FDA data

Neomycin and Polymyxin B Sulfates, and Bacitracin Zinc

Product NDC
17478-235
11-digit product format
174780235
Labeler code
17478
Product ID
17478-235_a9914212-eac0-4504-8efa-7cfc2a1379b6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Neomycin Sulfate, Polymyxin B Sulfate and Bacitracin Zinc
Dosage form
OINTMENT
Route
OPHTHALMIC
Labeler
Akorn
Application
ANDA065088
Marketing category
ANDA
Marketing start
1990-09-30
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
17478-235-352024-01-30C16284748780-11030e365-6388-111a-e063-dadaa90a10e2Neomycin and Polymyxin B Sulfates and Bacitracin Zinc Ophthalmic Ointment, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
17478-235-35Neomycin and Polymyxin B Sulfates, and Bacitracin Zinc1 in 1 CARTONOINTMENT16
17478-235-35Neomycin and Polymyxin B Sulfates, and Bacitracin Zinc3.5 g in 1 TUBEOINTMENT3.56

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
17478-235-35GM - Gram17478-235d93722ff-f8f8-4b0f-b21f-e07aae36b47a12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Bacitracin ZincACTIVE INGREDIENT89Y4M234ESNEOMYCIN AND POLYMYXIN B SULFATES, AND BACITRACIN ZINC (NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND BACITRACIN ZINC) OINTMENT [AKORN, INC.]2
Neomycin SulfateACTIVE INGREDIENT057Y626693NEOMYCIN AND POLYMYXIN B SULFATES, AND BACITRACIN ZINC (NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND BACITRACIN ZINC) OINTMENT [AKORN, INC.]2
Polymyxin B SulfateACTIVE INGREDIENT19371312D4NEOMYCIN AND POLYMYXIN B SULFATES, AND BACITRACIN ZINC (NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND BACITRACIN ZINC) OINTMENT [AKORN, INC.]2
BacitracinACTIVE MOIETY58H6RWO52INEOMYCIN AND POLYMYXIN B SULFATES, AND BACITRACIN ZINC (NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND BACITRACIN ZINC) OINTMENT [AKORN, INC.]2
NeomycinACTIVE MOIETYI16QD7X297NEOMYCIN AND POLYMYXIN B SULFATES, AND BACITRACIN ZINC (NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND BACITRACIN ZINC) OINTMENT [AKORN, INC.]2
Polymyxin BACTIVE MOIETYJ2VZ07J96KNEOMYCIN AND POLYMYXIN B SULFATES, AND BACITRACIN ZINC (NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND BACITRACIN ZINC) OINTMENT [AKORN, INC.]2
PetrolatumINACTIVE INGREDIENT4T6H12BN9UNEOMYCIN AND POLYMYXIN B SULFATES, AND BACITRACIN ZINC (NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND BACITRACIN ZINC) OINTMENT [AKORN, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
17478-235NEOMYCIN AND POLYMYXIN B SULFATES, AND BACITRACIN ZINC (NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND BACITRACIN ZINC) OINTMENT [AKORN]6Legacy NDC, 2 package rows20220202_3cac80c3-0798-4f8a-9756-d5b05d3d2dca.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 OintmentPSN3cac80c3-0798-4f8a-9756-d5b05d3d2dca6
308493bacitracin 0.4 UNT/MG / neomycin 0.0035 MG/MG / polymyxin B 10 UNT/MG Ophthalmic OintmentSCD3cac80c3-0798-4f8a-9756-d5b05d3d2dca6
308493bacitracin 0.4 UNT/MG / neomycin 0.35 % / polymyxin B 10 UNT/MG Ophthalmic OintmentSY3cac80c3-0798-4f8a-9756-d5b05d3d2dca6
308493bacitracin 400 UNT / neomycin 3.5 MG / polymyxin B 10,000 UNT per GM Ophthalmic OintmentSY3cac80c3-0798-4f8a-9756-d5b05d3d2dca6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
17478-235-35174780235351 TUBE in 1 CARTON (17478-235-35) > 3.5 g in 1 TUBE1 tube1990-09-300000-00-00NoNoCurrent