Neomycin and Polymyxin B Sulfates and Bacitracin Zinc

Product NDC
21695-192
11-digit product format
216950192
Labeler code
21695
Product ID
21695-192_65b71a14-dcb5-4123-b4c5-033c9e16a22a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Neomycin sulfate, Polymyxin B Sulfate and Bacitracin Zinc
Dosage form
OINTMENT
Route
OPHTHALMIC
Labeler
Rebel Distributors Corp
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; mg/g; ug/g
Pharmacologic classes
Polymyxin-class Antibacterial [EPC],Polymyxins [CS],Decreased Cell Wall Synthesis & Repair [PE],Aminoglycoside Antibacterial [EPC],Aminoglycosides [CS]
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
21695-192-352019-09-24C16284748780-1934fe258-4b09-48b1-e053-8cdaa90a720aNeomycin and Polymyxin B Sulfates and Bacitracin Zinc Ophthalmic Ointment USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21695-192-35Neomycin and Polymyxin B Sulfates and Bacitracin Zinc3.5 g in 1 TUBEOINTMENT3.51

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
21695-192-35GM - Gram21695-192a29db007-702b-4d86-9ab7-63b5a0b8fabd12012-07-24

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 [REBEL DISTRIBUTORS CORP]1
Neomycin SulfateACTIVE INGREDIENT057Y626693NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC (NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND BACITRACIN ZINC) OINTMENT [REBEL DISTRIBUTORS CORP]1
Polymyxin B SulfateACTIVE INGREDIENT19371312D4NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC (NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND BACITRACIN ZINC) OINTMENT [REBEL DISTRIBUTORS CORP]1
BacitracinACTIVE MOIETY58H6RWO52INEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC (NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND BACITRACIN ZINC) OINTMENT [REBEL DISTRIBUTORS CORP]1
NeomycinACTIVE MOIETYI16QD7X297NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC (NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND BACITRACIN ZINC) OINTMENT [REBEL DISTRIBUTORS CORP]1
polymyxin BACTIVE MOIETYJ2VZ07J96KNEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC (NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND BACITRACIN ZINC) OINTMENT [REBEL DISTRIBUTORS CORP]1
MINERAL OILINACTIVE INGREDIENTT5L8T28FGPNEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC (NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND BACITRACIN ZINC) OINTMENT [REBEL DISTRIBUTORS CORP]1
PETROLATUMINACTIVE INGREDIENT4T6H12BN9UNEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC (NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND BACITRACIN ZINC) OINTMENT [REBEL DISTRIBUTORS CORP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21695-192NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC (NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND BACITRACIN ZINC) OINTMENT [REBEL DISTRIBUTORS CORP]1Legacy NDC, 1 package rows20110113_65b71a14-dcb5-4123-b4c5-033c9e16a22a.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 OintmentPSN65b71a14-dcb5-4123-b4c5-033c9e16a22a1
308493bacitracin 0.4 UNT/MG / neomycin 0.0035 MG/MG / polymyxin B 10 UNT/MG Ophthalmic OintmentSCD65b71a14-dcb5-4123-b4c5-033c9e16a22a1
308493bacitracin 0.4 UNT/MG / neomycin 0.35 % / polymyxin B 10 UNT/MG Ophthalmic OintmentSY65b71a14-dcb5-4123-b4c5-033c9e16a22a1
308493bacitracin 400 UNT / neomycin 3.5 MG / polymyxin B 10,000 UNT per GM Ophthalmic OintmentSY65b71a14-dcb5-4123-b4c5-033c9e16a22a1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
21695-192-35216950192353.5 g in 1 TUBE3.5 gHistorical