NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN

Product NDC
55045-1194
11-digit product format
550451194
Labeler code
55045
Product ID
55045-1194_07080003-b495-447a-bb9d-0efbe866e37a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
neomycin sulfate, polymyxin b sulfate and gramicidin
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
Dispensing Solutions, Inc.
Application
ANDA064047
Marketing category
ANDA
Marketing start
1996-01-31
Marketing end
0000-00-00
Substance
NEOMYCIN SULFATE; POLYMYXIN B SULFATE; GRAMICIDIN
Active strength
2 mg/mL; [USP'U]/mL; mg/mL
Pharmacologic classes
Aminoglycoside Antibacterial [EPC],Aminoglycosides [CS],Polymyxin-class Antibacterial [EPC],Polymyxins [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
b045ad64-0f28-9a02-2f9b-b34d94fb2278Product name120140508
b6082387-f592-1148-0844-bd068fd213fbProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
55045-1194-22019-11-13C16284748780-197449f38-be73-f6ea-e053-dbdaa90aa703Neomycin and Polymyxin B Sulfates and Gramicidin Ophthalmic Solution USP (Sterile)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55045-1194-2NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN10 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS103
55045-1194-2NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN1 in 1 CARTONSOLUTION/ DROPS13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
GRAMICIDINACTIVE INGREDIENT5IE62321P4NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN (NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND GRAMICIDIN) SOLUTION/ DROPS [DISPENSING SOLUTIONS, INC.]3
NEOMYCIN SULFATEACTIVE INGREDIENT057Y626693NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN (NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND GRAMICIDIN) SOLUTION/ DROPS [DISPENSING SOLUTIONS, INC.]3
POLYMYXIN B SULFATEACTIVE INGREDIENT19371312D4NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN (NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND GRAMICIDIN) SOLUTION/ DROPS [DISPENSING SOLUTIONS, INC.]3
GRAMICIDINACTIVE MOIETY5IE62321P4NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN (NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND GRAMICIDIN) SOLUTION/ DROPS [DISPENSING SOLUTIONS, INC.]3
NEOMYCINACTIVE MOIETYI16QD7X297NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN (NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND GRAMICIDIN) SOLUTION/ DROPS [DISPENSING SOLUTIONS, INC.]3
POLYMYXIN BACTIVE MOIETYJ2VZ07J96KNEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN (NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND GRAMICIDIN) SOLUTION/ DROPS [DISPENSING SOLUTIONS, INC.]3
AlcoholINACTIVE INGREDIENT3K9958V90MNEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN (NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND GRAMICIDIN) SOLUTION/ DROPS [DISPENSING SOLUTIONS, INC.]3
AMMONIAINACTIVE INGREDIENT5138Q19F1XNEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN (NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND GRAMICIDIN) SOLUTION/ DROPS [DISPENSING SOLUTIONS, INC.]3
Hydrochloric AcidINACTIVE INGREDIENTQTT17582CBNEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN (NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND GRAMICIDIN) SOLUTION/ DROPS [DISPENSING SOLUTIONS, INC.]3
Poloxamer 188INACTIVE INGREDIENTLQA7B6G8JGNEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN (NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND GRAMICIDIN) SOLUTION/ DROPS [DISPENSING SOLUTIONS, INC.]3
Propylene GlycolINACTIVE INGREDIENT6DC9Q167V3NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN (NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND GRAMICIDIN) SOLUTION/ DROPS [DISPENSING SOLUTIONS, INC.]3
Sodium ChlorideINACTIVE INGREDIENT451W47IQ8XNEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN (NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND GRAMICIDIN) SOLUTION/ DROPS [DISPENSING SOLUTIONS, INC.]3
WaterINACTIVE INGREDIENT059QF0KO0RNEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN (NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND GRAMICIDIN) SOLUTION/ DROPS [DISPENSING SOLUTIONS, INC.]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55045-1194NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN (NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND GRAMICIDIN) SOLUTION/ DROPS [DISPENSING SOLUTIONS, INC.]3Legacy NDC, 2 package rows20111110_94e3b620-f9b2-4c8b-9ee8-8b27207a2cab.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310594gramicidin 0.025 MG / neomycin sulfate 1.75 MG / polymyxin B sulfate 10,000 UNT per ML Ophthalmic SolutionPSN94e3b620-f9b2-4c8b-9ee8-8b27207a2cab3
310594gramicidin 0.025 MG/ML / neomycin 1.75 MG/ML / polymyxin B 10000 UNT/ML Ophthalmic SolutionSCD94e3b620-f9b2-4c8b-9ee8-8b27207a2cab3
310594gramicidin 0.025 MG / neomycin (as neomycin sulfate) 1.75 MG / polymyxin B (as polymyxin B sulfate) 10,000 UNT per ML Ophthalmic SolutionSY94e3b620-f9b2-4c8b-9ee8-8b27207a2cab3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
55045-1194-25504511940210 mL in 1 BOTTLE, DROPPER10 mlHistorical