FDA.reportPublic FDA data

NEO-POLYCIN

Product NDC
42254-302
11-digit product format
422540302
Labeler code
42254
Product ID
42254-302_23764466-adbe-4c9c-be60-3b09458d634e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC
Dosage form
OINTMENT
Route
OPHTHALMIC
Labeler
Rebel Distributors Corp
Application
ANDA060764
Marketing category
ANDA
Marketing start
2011-07-15
Marketing end
0000-00-00
Substance
NEOMYCIN SULFATE; POLYMYXIN B SULFATE; BACITRACIN ZINC
Active strength
4 mg/g; U/g; 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
42254-302-352019-09-24C16284748780-19350213a-3d04-c013-e053-90daa90a1393NEO-POLYCIN

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42254-302-35NEO-POLYCIN3.5 g in 1 TUBEOINTMENT3.51
42254-302-35NEO-POLYCIN1 in 1 CARTONOINTMENT11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42254-302-35GM - Gram42254-3026bafd475-c31c-4904-b1e7-5e6484c920f112013-04-01

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BACITRACIN ZINCACTIVE INGREDIENT89Y4M234ESNEO-POLYCIN (NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC) OINTMENT [REBEL DISTRIBUTORS CORP]1
NEOMYCIN SULFATEACTIVE INGREDIENT057Y626693NEO-POLYCIN (NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC) OINTMENT [REBEL DISTRIBUTORS CORP]1
POLYMYXIN B SULFATEACTIVE INGREDIENT19371312D4NEO-POLYCIN (NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC) OINTMENT [REBEL DISTRIBUTORS CORP]1
BACITRACINACTIVE MOIETY58H6RWO52INEO-POLYCIN (NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC) OINTMENT [REBEL DISTRIBUTORS CORP]1
NEOMYCINACTIVE MOIETYI16QD7X297NEO-POLYCIN (NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC) OINTMENT [REBEL DISTRIBUTORS CORP]1
POLYMYXIN BACTIVE MOIETYJ2VZ07J96KNEO-POLYCIN (NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC) OINTMENT [REBEL DISTRIBUTORS CORP]1
MINERAL OILINACTIVE INGREDIENTT5L8T28FGPNEO-POLYCIN (NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC) OINTMENT [REBEL DISTRIBUTORS CORP]1
PETROLATUMINACTIVE INGREDIENT4T6H12BN9UNEO-POLYCIN (NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC) OINTMENT [REBEL DISTRIBUTORS CORP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42254-302NEO-POLYCIN (NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC) OINTMENT [REBEL DISTRIBUTORS CORP]1Legacy NDC, 2 package rows20130329_23764466-adbe-4c9c-be60-3b09458d634e.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 OintmentPSN23764466-adbe-4c9c-be60-3b09458d634e1
1117090Neo-Polycin 400 UNT / 3.5 MG / 10,000 UNT per GM Ophthalmic OintmentPSN23764466-adbe-4c9c-be60-3b09458d634e1
1117090bacitracin 0.4 UNT/MG / neomycin 0.0035 MG/MG / polymyxin B 10 UNT/MG Ophthalmic Ointment [Neo-Polycin]SBD23764466-adbe-4c9c-be60-3b09458d634e1
308493bacitracin 0.4 UNT/MG / neomycin 0.0035 MG/MG / polymyxin B 10 UNT/MG Ophthalmic OintmentSCD23764466-adbe-4c9c-be60-3b09458d634e1
308493bacitracin 0.4 UNT/MG / neomycin 0.35 % / polymyxin B 10 UNT/MG Ophthalmic OintmentSY23764466-adbe-4c9c-be60-3b09458d634e1
308493bacitracin 400 UNT / neomycin 3.5 MG / polymyxin B 10,000 UNT per GM Ophthalmic OintmentSY23764466-adbe-4c9c-be60-3b09458d634e1
1117090Neo-Polycin (bacitracin 400 UNT / neomycin 3.5 MG / polymyxin B 10,000 UNT per GM) Ophthalmic OintmentSY23764466-adbe-4c9c-be60-3b09458d634e1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
42254-302-35422540302353.5 g in 1 TUBE3.5 gHistorical