NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE

Product NDC
61919-662
11-digit product format
619190662
Labeler code
61919
Product ID
61919-662_9caacf41-212b-b2f3-e053-2a95a90aee1b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE
Dosage form
SUSPENSION/ DROPS
Route
AURICULAR (OTIC)
Labeler
DIRECT RX
Application
ANDA064065
Marketing category
ANDA
Marketing start
2014-01-01
Marketing end
0000-00-00
Substance
HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE
Active strength
10 mg/mL; mg/mL; [USP'U]/mL
Pharmacologic classes
Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA],Aminoglycoside Antibacterial [EPC],Aminoglycosides [CS],Polymyxin-class Antibacterial [EPC],Polymyxins [CS]
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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626d7260-31b5-4412-84fd-579746adb6b3Product name120210513
8a011600-5e61-4c59-ab7b-54ab658a3b71Product name220181127
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fcce390d-6460-4701-87cf-940d8800a1c3Product name220180212
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705740e1-dee5-2610-c5a3-4c59cd9d62afProduct name120140508
7bdc4804-3832-c0df-e519-72b6d47c9792Product name120140508
a7051cba-790b-a699-81f8-dbbbdbd9b5acProduct name120140508
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bfd28ffb-d550-3fe9-f65b-10bcb7f971fdProduct name120140508
da108d9e-edc8-17a3-8c28-3251c6a8acccProduct name120140508
fe21f3fd-a378-0654-1972-db3c3b64470eProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61919-662-102023-01-30C16284748780-1f386c649-f897-0266-e053-dadaa90a7c1aNEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-662-10NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE10 mL in 1 BOTTLE, DROPPERSUSPENSION/ DROPS103

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-662-10ML - Milliliter61919-6625c9d3c14-a02c-4859-ba54-4abb5e2300c312015-04-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
HYDROCORTISONEACTIVE INGREDIENTWI4X0X7BPJNEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE SUSPENSION/ DROPS [DIRECT RX]1
NEOMYCIN SULFATEACTIVE INGREDIENT057Y626693NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE SUSPENSION/ DROPS [DIRECT RX]1
POLYMYXIN B SULFATEACTIVE INGREDIENT19371312D4NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE SUSPENSION/ DROPS [DIRECT RX]1
HYDROCORTISONEACTIVE MOIETYWI4X0X7BPJNEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE SUSPENSION/ DROPS [DIRECT RX]1
NEOMYCINACTIVE MOIETYI16QD7X297NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE SUSPENSION/ DROPS [DIRECT RX]1
POLYMYXIN BACTIVE MOIETYJ2VZ07J96KNEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE SUSPENSION/ DROPS [DIRECT RX]1
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCNNEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE SUSPENSION/ DROPS [DIRECT RX]1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HNEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE SUSPENSION/ DROPS [DIRECT RX]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE SUSPENSION/ DROPS [DIRECT RX]1
SULFURIC ACIDINACTIVE INGREDIENTO40UQP6WCFNEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE SUSPENSION/ DROPS [DIRECT RX]1
THIMEROSALINACTIVE INGREDIENT2225PI3MOVNEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE SUSPENSION/ DROPS [DIRECT RX]1
WATERINACTIVE INGREDIENT059QF0KO0RNEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE SUSPENSION/ DROPS [DIRECT RX]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-662NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE SUSPENSION/ DROPS [DIRECT RX]3Legacy NDC, 1 package rows20200130_cb105db7-ab14-4b10-8a19-58bcb5eb27cd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310687hydrocortisone 10 MG (1 % ) / neomycin sulfate 3.5 MG / polymyxin B sulfate 10,000 UNT per mL Otic SuspensionPSNcb105db7-ab14-4b10-8a19-58bcb5eb27cd3
310687hydrocortisone 10 MG/ML / neomycin 3.5 MG/ML / polymyxin B 10000 UNT/ML Otic SuspensionSCDcb105db7-ab14-4b10-8a19-58bcb5eb27cd3
310687hydrocortisone 10 MG / neomycin 3.5 MG / polymyxin B 10,000 UNT per 1 ML Otic SuspensionSYcb105db7-ab14-4b10-8a19-58bcb5eb27cd3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61919-662-106191906621010 mL in 1 BOTTLE, DROPPER (61919-662-10) 10 ml2014-01-010000-00-00NoNoCurrent