Home NDC 68788-8130 Neomycin and Polymyxin B Sulfates and Hydrocortisone
Product NDC 68788-8130
11-digit product format 687888130
Labeler code 68788
Product ID 68788-8130_5a5f34a7-29d7-4089-a6eb-0e32a036e953
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name neomycin sulfate, polymyxin b sulfate and hydrocortisone
Dosage form SUSPENSION
Route AURICULAR (OTIC)
Labeler Preferred Pharmaceuticals Inc.
Application ANDA062488
Marketing category ANDA
Marketing start 2022-02-03
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 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 68788-8130-1 Neomycin and Polymyxin B Sulfates and Hydrocortisone 10 mL in 1 BOTTLE, PLASTIC SUSPENSION 10 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68788-8130 NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE (NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND HYDROCORTISONE) SUSPENSION [PREFERRED PHARMACEUTICALS INC.] 3 Current NDC, Legacy NDC, 1 package rows 20240724_e7c7d23c-25f0-41ea-a563-59f46882d9fc.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 68788-8130-1 68788813001 10 mL in 1 BOTTLE, PLASTIC (68788-8130-1) 10 ml 2022-02-03 0000-00-00 No No Current