Neomycin and Polymyxin B Sulfates and Dexamethasone

Product NDC
21695-595
11-digit product format
216950595
Labeler code
21695
Product ID
21695-595_8060a686-f1e1-4171-9b99-28791e502bdb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
neomycin sulfate, polymyxin B sulfate and dexamethasone
Dosage form
SUSPENSION
Route
OPHTHALMIC
Labeler
Rebel Distributors Corp
Application
ANDA062721
Marketing category
ANDA
Marketing start
1986-11-17
Marketing end
0000-00-00
Substance
NEOMYCIN SULFATE; POLYMYXIN B SULFATE; DEXAMETHASONE
Active strength
4 mg/mL; mg/mL; mg/mL
Pharmacologic classes
Aminoglycoside Antibacterial [EPC],Aminoglycosides [CS],Polymyxin-class Antibacterial [EPC],Polymyxins [CS],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
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
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81e34474-b0a5-434f-8104-25d689efc99eProduct name120200303
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9ea85abb-fa68-5da6-ab60-2c7eef579000Product name120140508
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b6082387-f592-1148-0844-bd068fd213fbProduct name120140508
d029211e-5e6b-725f-3696-ac6ff77da222Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
21695-595-052019-09-24C16284748780-1934fe258-4965-48b1-e053-8cdaa90a720aNeomycin and Polymyxin B Sulfates and Dexamethasone Ophthalmic Suspension Sterile

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21695-595-05Neomycin and Polymyxin B Sulfates and Dexamethasone5 mL in 1 BOTTLE, PLASTICSUSPENSION51

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
21695-595-05ML - Milliliter21695-595a74d321b-ec4a-4b81-8006-32ccb7c56b8412012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
dexamethasoneACTIVE INGREDIENT7S5I7G3JQLNEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE (NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND DEXAMETHASONE) SUSPENSION [REBEL DISTRIBUTORS CORP]1
neomycin sulfateACTIVE INGREDIENT057Y626693NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE (NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND DEXAMETHASONE) SUSPENSION [REBEL DISTRIBUTORS CORP]1
polymyxin B sulfateACTIVE INGREDIENT19371312D4NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE (NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND DEXAMETHASONE) SUSPENSION [REBEL DISTRIBUTORS CORP]1
dexamethasoneACTIVE MOIETY7S5I7G3JQLNEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE (NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND DEXAMETHASONE) SUSPENSION [REBEL DISTRIBUTORS CORP]1
neomycinACTIVE MOIETYI16QD7X297NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE (NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND DEXAMETHASONE) SUSPENSION [REBEL DISTRIBUTORS CORP]1
polymyxin BACTIVE MOIETYJ2VZ07J96KNEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE (NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND DEXAMETHASONE) SUSPENSION [REBEL DISTRIBUTORS CORP]1
BENZALKONIUM CHLORIDEINACTIVE INGREDIENTF5UM2KM3W7NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE (NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND DEXAMETHASONE) SUSPENSION [REBEL DISTRIBUTORS CORP]1
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBNEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE (NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND DEXAMETHASONE) SUSPENSION [REBEL DISTRIBUTORS CORP]1
HYPROMELLOSE 2910 (15 MPA.S)INACTIVE INGREDIENT36SFW2JZ0WNEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE (NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND DEXAMETHASONE) SUSPENSION [REBEL DISTRIBUTORS CORP]1
POLYSORBATE 20INACTIVE INGREDIENT7T1F30V5YHNEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE (NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND DEXAMETHASONE) SUSPENSION [REBEL DISTRIBUTORS CORP]1
sodium chlorideINACTIVE INGREDIENT451W47IQ8XNEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE (NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND DEXAMETHASONE) SUSPENSION [REBEL DISTRIBUTORS CORP]1
waterINACTIVE INGREDIENT059QF0KO0RNEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE (NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND DEXAMETHASONE) SUSPENSION [REBEL DISTRIBUTORS CORP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21695-595NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE (NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND DEXAMETHASONE) SUSPENSION [REBEL DISTRIBUTORS CORP]1Legacy NDC, 1 package rows20101123_8060a686-f1e1-4171-9b99-28791e502bdb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309680neomycin sulfate 3.5 MG/ML / polymyxin B sulfate 10,000 UNT/mL / dexAMETHasone 0.1 % Ophthalmic SuspensionPSN8060a686-f1e1-4171-9b99-28791e502bdb1
309680dexamethasone 1 MG/ML / neomycin 3.5 MG/ML / polymyxin B 10000 UNT/ML Ophthalmic SuspensionSCD8060a686-f1e1-4171-9b99-28791e502bdb1
309680dexamethasone 0.1 % / neomycin 0.35 % / polymyxin B 10,000 UNT per ML Ophthalmic SuspensionSY8060a686-f1e1-4171-9b99-28791e502bdb1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
21695-595-05216950595055 mL in 1 BOTTLE, PLASTIC5 mlHistorical