NEOMYCIN POLYMYXIN B SULFATES AND DEXAMETHASONE

Product NDC
61919-167
11-digit product format
619190167
Labeler code
61919
Product ID
61919-167_27067d35-4e4c-4961-beaf-28e631b37349
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
NEOMYCIN POLYMYXIN B SULFATES AND DEXAMETHASONE
Dosage form
SUSPENSION/ DROPS
Route
OPHTHALMIC
Labeler
DIRECT RX
Application
ANDA064135
Marketing category
ANDA
Marketing start
2015-01-01
Marketing end
0000-00-00
Substance
NEOMYCIN SULFATE; POLYMYXIN B SULFATE; DEXAMETHASONE
Active strength
4 mg/mL; [USP'U]/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
05ab9c01-cd9a-4f59-b2e8-ddcb887cac39Product name120190408
0c7dba41-c919-5809-508d-4affe6cfcff2Product name220170817
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725d71bf-f956-5cad-e556-fa39cb060dc8Product name120140508
9ea85abb-fa68-5da6-ab60-2c7eef579000Product name120140508
b045ad64-0f28-9a02-2f9b-b34d94fb2278Product name120140508
b6082387-f592-1148-0844-bd068fd213fbProduct name120140508
d029211e-5e6b-725f-3696-ac6ff77da222Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61919-167-052020-01-31C16284748780-19d75b9d1-285f-f424-e053-dadaa90a57ceNEOMYCIN POLYMYXIN B SULFATES AND DEXAMETHASONE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-167-05NEOMYCIN POLYMYXIN B SULFATES AND DEXAMETHASONE5 mL in 1 BOTTLE, DROPPERSUSPENSION/ DROPS54

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-167-05ML - Milliliter61919-167363ae4e4-8400-4c22-9034-51d9759079ac12015-04-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DEXAMETHASONEACTIVE INGREDIENT7S5I7G3JQLNEOMYCIN POLYMYXIN B SULFATES AND DEXAMETHASONE SUSPENSION/ DROPS [DIRECT RX]4
NEOMYCIN SULFATEACTIVE INGREDIENT057Y626693NEOMYCIN POLYMYXIN B SULFATES AND DEXAMETHASONE SUSPENSION/ DROPS [DIRECT RX]4
POLYMYXIN B SULFATEACTIVE INGREDIENT19371312D4NEOMYCIN POLYMYXIN B SULFATES AND DEXAMETHASONE SUSPENSION/ DROPS [DIRECT RX]4
DEXAMETHASONEACTIVE MOIETY7S5I7G3JQLNEOMYCIN POLYMYXIN B SULFATES AND DEXAMETHASONE SUSPENSION/ DROPS [DIRECT RX]4
NEOMYCINACTIVE MOIETYI16QD7X297NEOMYCIN POLYMYXIN B SULFATES AND DEXAMETHASONE SUSPENSION/ DROPS [DIRECT RX]4
POLYMYXIN BACTIVE MOIETYJ2VZ07J96KNEOMYCIN POLYMYXIN B SULFATES AND DEXAMETHASONE SUSPENSION/ DROPS [DIRECT RX]4
BENZALKONIUM CHLORIDEINACTIVE INGREDIENTF5UM2KM3W7NEOMYCIN POLYMYXIN B SULFATES AND DEXAMETHASONE SUSPENSION/ DROPS [DIRECT RX]4
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBNEOMYCIN POLYMYXIN B SULFATES AND DEXAMETHASONE SUSPENSION/ DROPS [DIRECT RX]4
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WONEOMYCIN POLYMYXIN B SULFATES AND DEXAMETHASONE SUSPENSION/ DROPS [DIRECT RX]4
POLYSORBATE 20INACTIVE INGREDIENT7T1F30V5YHNEOMYCIN POLYMYXIN B SULFATES AND DEXAMETHASONE SUSPENSION/ DROPS [DIRECT RX]4
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XNEOMYCIN POLYMYXIN B SULFATES AND DEXAMETHASONE SUSPENSION/ DROPS [DIRECT RX]4
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32INEOMYCIN POLYMYXIN B SULFATES AND DEXAMETHASONE SUSPENSION/ DROPS [DIRECT RX]4
WATERINACTIVE INGREDIENT059QF0KO0RNEOMYCIN POLYMYXIN B SULFATES AND DEXAMETHASONE SUSPENSION/ DROPS [DIRECT RX]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-167NEOMYCIN POLYMYXIN B SULFATES AND DEXAMETHASONE SUSPENSION/ DROPS [DIRECT RX]4Legacy NDC, 1 package rows20150812_e4df24bb-c4ed-497f-bf06-9cd6837ea90f.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 SuspensionPSNe4df24bb-c4ed-497f-bf06-9cd6837ea90f4
309680dexamethasone 1 MG/ML / neomycin 3.5 MG/ML / polymyxin B 10000 UNT/ML Ophthalmic SuspensionSCDe4df24bb-c4ed-497f-bf06-9cd6837ea90f4
309680dexamethasone 0.1 % / neomycin 0.35 % / polymyxin B 10,000 UNT per ML Ophthalmic SuspensionSYe4df24bb-c4ed-497f-bf06-9cd6837ea90f4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
61919-167-05619190167055 mL in 1 BOTTLE, DROPPER5 mlHistorical