Home NDC 68788-7787 Neomycin and Polymyxin B Sulfates and Hydrocortisone Otic Suspension
Product NDC 68788-7787
11-digit product format 687887787
Labeler code 68788
Product ID 68788-7787_c5bbee8b-5814-48bc-b46c-254fd3852b05
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name neomycin and polymyxin B sulfates and hydrocortisone otic
Dosage form SUSPENSION
Route AURICULAR (OTIC)
Labeler Preferred Pharmaceuticals, Inc.
Application NDA060613
Marketing category NDA AUTHORIZED GENERIC
Marketing start 2020-10-21
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 Otic Suspension
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength HYDROCORTISONE 10 mg/mL NEOMYCIN SULFATE 3.5 mg/mL POLYMYXIN B SULFATE 10000 [USP'U]/mL
Harmonized Identifiers# Field, Values table Field Values Unii WI4X0X7BPJ, 057Y626693, 19371312D4 Rxcui 310687
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 68788-7787-1 Neomycin and Polymyxin B Sulfates and Hydrocortisone Otic Suspension 10 mL in 1 BOTTLE SUSPENSION 10 6 68788-7787-1 Neomycin and Polymyxin B Sulfates and Hydrocortisone Otic Suspension 1 in 1 CARTON SUSPENSION 1 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68788-7787 NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE OTIC SUSPENSION (NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE OTIC) SUSPENSION [PREFERRED PHARMACEUTICALS, INC.] 5 Current NDC, Legacy NDC, 2 package rows 20240724_5f17fae0-c6ea-452e-b84f-066caf2a95fc.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 68788-7787-1 68788778701 1 BOTTLE in 1 CARTON (68788-7787-1) / 10 mL in 1 BOTTLE 1 bottle 2020-10-21 0000-00-00 No No Current