Neomycin and Polymyxin B Sulfates and Hydrocortisone

Product NDC
68071-2735
11-digit product format
680712735
Labeler code
68071
Product ID
68071-2735_2a7fb18d-ef2a-2218-e063-6394a90af89f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
neomycin sulfate, polymyxin b sulfate and hydrocortisone
Dosage form
SOLUTION
Route
AURICULAR (OTIC)
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA062423
Marketing category
ANDA
Marketing start
2003-03-18
Substance
HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE
Active strength
10; 3.5; 10000 mg/mL; mg/mL; [iU]/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

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
WI4X0X7BPJHYDROCORTISONE50-23-7HYDROCORTISONE
057Y626693NEOMYCIN SULFATE1405-10-3NEOMYCIN SULFATE
19371312D4POLYMYXIN B SULFATE1405-20-5POLYMYXIN B SULFATE

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68071-2735-16807127350110 mL in 1 BOTTLE (68071-2735-1) 10 ml2022-05-26NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Neomycin and Polymyxin B Sulfates and Hydrocortisone OTIC Solution, USP SterileNuCare Pharmaceuticals,Inc.2024-12-30HUMAN PRESCRIPTION DRUG LABEL2