FDA.reportPublic FDA data

Neomycin and Polymyxin B Sulfates and Hydrocortisone

Product NDC
61314-645
11-digit product format
613140645
Labeler code
61314
Product ID
61314-645_99d0c7c1-3bf0-4491-b093-551555f7e80c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
neomycin sulfate, polymyxin b sulfate and hydrocortisone
Dosage form
SUSPENSION
Route
AURICULAR (OTIC)
Labeler
Sandoz Inc.
Application
ANDA062488
Marketing category
ANDA
Marketing start
2003-03-17
Substance
HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE
Active strength
10; 3.5; 10000 mg/mL; mg/mL; [USP'U]/mL
Pharmacologic classes
Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Neomycin and Polymyxin B Sulfates and Hydrocortisone
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HYDROCORTISONE10 mg/mL
NEOMYCIN SULFATE3.5 mg/mL
POLYMYXIN B SULFATE10000 [USP'U]/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiWI4X0X7BPJ, 057Y626693, 19371312D4
Rxcui310687

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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4d56e8eb-d741-d4a5-de3f-2bab1af75a60Product name720220608
626d7260-31b5-4412-84fd-579746adb6b3Product name120210513
8a011600-5e61-4c59-ab7b-54ab658a3b71Product name220181127
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48747306-602a-42cc-957b-5b0c69158eeeProduct name120180604
fcce390d-6460-4701-87cf-940d8800a1c3Product name220180212
99e684e6-f435-feb8-d2bb-3a546f1cb768Product name220161117
25340b3b-3e4c-4ff8-abf6-3e62ec46bd0cProduct name120160603
bf065fa6-1e3b-e4c3-0bde-2dc842ceeea1Product name220150218
02657a3f-1489-66ea-f740-5ab9524e57d7Product name120140508
26f3d783-2cc1-4327-e77d-71804cf675a2Product name120140508
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58f3f9b7-3b9b-a9c1-1c9f-18ac777192b8Product name120140508
61e59a42-186b-9f4b-aec3-fb49a6debc31Product name120140508
705740e1-dee5-2610-c5a3-4c59cd9d62afProduct name120140508
7bdc4804-3832-c0df-e519-72b6d47c9792Product name120140508
a7051cba-790b-a699-81f8-dbbbdbd9b5acProduct name120140508
abaf203f-619e-f265-559f-8c81af5cb1c2Product name120140508
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b6082387-f592-1148-0844-bd068fd213fbProduct name120140508
bfd28ffb-d550-3fe9-f65b-10bcb7f971fdProduct name120140508
da108d9e-edc8-17a3-8c28-3251c6a8acccProduct name120140508
db5ebcdb-b6ae-21cd-4dc5-76cd84b5578bProduct name120140508
fe21f3fd-a378-0654-1972-db3c3b64470eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61314-645-11Neomycin and Polymyxin B Sulfates and Hydrocortisone10 mL in 1 BOTTLE, PLASTICSUSPENSION109

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61314-645-11ML - Milliliter61314-6452f567db3-948d-4371-af1b-8fcb2a86ebc112012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
HYDROCORTISONEACTIVE INGREDIENTWI4X0X7BPJNEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE (NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND HYDROCORTISONE) SUSPENSION [FALCON PHARMACEUTICALS, LTD.]4
NEOMYCIN SULFATEACTIVE INGREDIENT057Y626693NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE (NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND HYDROCORTISONE) SUSPENSION [FALCON PHARMACEUTICALS, LTD.]4
POLYMYXIN B SULFATEACTIVE INGREDIENT19371312D4NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE (NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND HYDROCORTISONE) SUSPENSION [FALCON PHARMACEUTICALS, LTD.]4
HYDROCORTISONEACTIVE MOIETYWI4X0X7BPJNEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE (NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND HYDROCORTISONE) SUSPENSION [FALCON PHARMACEUTICALS, LTD.]4
NEOMYCINACTIVE MOIETYI16QD7X297NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE (NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND HYDROCORTISONE) SUSPENSION [FALCON PHARMACEUTICALS, LTD.]4
POLYMYXIN BACTIVE MOIETYJ2VZ07J96KNEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE (NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND HYDROCORTISONE) SUSPENSION [FALCON PHARMACEUTICALS, LTD.]4
ACETIC ACIDINACTIVE INGREDIENTQ40Q9N063PNEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE (NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND HYDROCORTISONE) SUSPENSION [FALCON PHARMACEUTICALS, LTD.]4
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCNNEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE (NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND HYDROCORTISONE) SUSPENSION [FALCON PHARMACEUTICALS, LTD.]4
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HNEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE (NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND HYDROCORTISONE) SUSPENSION [FALCON PHARMACEUTICALS, LTD.]4
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE (NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND HYDROCORTISONE) SUSPENSION [FALCON PHARMACEUTICALS, LTD.]4
THIMEROSALINACTIVE INGREDIENT2225PI3MOVNEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE (NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND HYDROCORTISONE) SUSPENSION [FALCON PHARMACEUTICALS, LTD.]4
WATERINACTIVE INGREDIENT059QF0KO0RNEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE (NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND HYDROCORTISONE) SUSPENSION [FALCON PHARMACEUTICALS, LTD.]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61314-645NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE (NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND HYDROCORTISONE) SUSPENSION [SANDOZ INC.]9Current NDC, Legacy NDC, 1 package rows20220216_99d9030f-9118-412c-a377-d1df1c8fa723.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 SuspensionPSN7a8e4f05-60f3-4492-a204-f26a251d8f65102
310687hydrocortisone 10 MG/ML / neomycin 3.5 MG/ML / polymyxin B 10000 UNT/ML Otic SuspensionSCD7a8e4f05-60f3-4492-a204-f26a251d8f65102
310687hydrocortisone 10 MG / neomycin 3.5 MG / polymyxin B 10,000 UNT per 1 ML Otic SuspensionSY7a8e4f05-60f3-4492-a204-f26a251d8f65102
310687hydrocortisone 10 MG (1 % ) / neomycin sulfate 3.5 MG / polymyxin B sulfate 10,000 UNT per mL Otic SuspensionPSN84d32193-c2cc-4837-88d1-c7d7dc2c70429
310687hydrocortisone 10 MG (1 % ) / neomycin sulfate 3.5 MG / polymyxin B sulfate 10,000 UNT per mL Otic SuspensionPSN99d9030f-9118-412c-a377-d1df1c8fa7239
310687hydrocortisone 10 MG/ML / neomycin 3.5 MG/ML / polymyxin B 10000 UNT/ML Otic SuspensionSCD84d32193-c2cc-4837-88d1-c7d7dc2c70429
310687hydrocortisone 10 MG/ML / neomycin 3.5 MG/ML / polymyxin B 10000 UNT/ML Otic SuspensionSCD99d9030f-9118-412c-a377-d1df1c8fa7239
310687hydrocortisone 10 MG / neomycin 3.5 MG / polymyxin B 10,000 UNT per 1 ML Otic SuspensionSY84d32193-c2cc-4837-88d1-c7d7dc2c70429
310687hydrocortisone 10 MG / neomycin 3.5 MG / polymyxin B 10,000 UNT per 1 ML Otic SuspensionSY99d9030f-9118-412c-a377-d1df1c8fa7239
310687hydrocortisone 10 MG (1 % ) / neomycin sulfate 3.5 MG / polymyxin B sulfate 10,000 UNT per mL Otic SuspensionPSN601cab21-c211-4c34-be7b-f4fdd97a921a5
310687hydrocortisone 10 MG/ML / neomycin 3.5 MG/ML / polymyxin B 10000 UNT/ML Otic SuspensionSCD601cab21-c211-4c34-be7b-f4fdd97a921a5
310687hydrocortisone 10 MG / neomycin 3.5 MG / polymyxin B 10,000 UNT per 1 ML Otic SuspensionSY601cab21-c211-4c34-be7b-f4fdd97a921a5
310687hydrocortisone 10 MG (1 % ) / neomycin sulfate 3.5 MG / polymyxin B sulfate 10,000 UNT per mL Otic SuspensionPSNe7c7d23c-25f0-41ea-a563-59f46882d9fc4
310687hydrocortisone 10 MG/ML / neomycin 3.5 MG/ML / polymyxin B 10000 UNT/ML Otic SuspensionSCDe7c7d23c-25f0-41ea-a563-59f46882d9fc4
310687hydrocortisone 10 MG / neomycin 3.5 MG / polymyxin B 10,000 UNT per 1 ML Otic SuspensionSYe7c7d23c-25f0-41ea-a563-59f46882d9fc4
310687hydrocortisone 10 MG (1 % ) / neomycin sulfate 3.5 MG / polymyxin B sulfate 10,000 UNT per mL Otic SuspensionPSN2e386c9f-2f43-4c5f-b958-81da5b4250bb1
310687hydrocortisone 10 MG/ML / neomycin 3.5 MG/ML / polymyxin B 10000 UNT/ML Otic SuspensionSCD2e386c9f-2f43-4c5f-b958-81da5b4250bb1
310687hydrocortisone 10 MG / neomycin 3.5 MG / polymyxin B 10,000 UNT per 1 ML Otic SuspensionSY2e386c9f-2f43-4c5f-b958-81da5b4250bb1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61314-645-116131406451110 mL in 1 BOTTLE, PLASTIC (61314-645-11) 10 ml2003-03-170000-00-00NoNoCurrent