Home NDC 68788-9924 Neomycin and Polymyxin B Sulfates and Hydrocortisone
Product NDC 68788-9924
11-digit product format 687889924
Labeler code 68788
Product ID 68788-9924_cee1c117-8586-4735-aab3-8eeb4ed195ba
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Neomycin sulfate, Polymyxin B Sulfate and Hydrocortisone
Dosage form SUSPENSION/ DROPS
Route AURICULAR (OTIC)
Labeler Preferred Pharmaceuticals, Inc.
Application ANDA064065
Marketing category ANDA
Marketing start 2012-01-18
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# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 68788-9924-1 Neomycin and Polymyxin B Sulfates and Hydrocortisone 10 mL in 1 BOTTLE, DROPPER SUSPENSION/ DROPS 10 11 68788-9924-1 Neomycin and Polymyxin B Sulfates and Hydrocortisone 1 in 1 CARTON SUSPENSION/ DROPS 1 11
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded HYDROCORTISONE ACTIVE INGREDIENT WI4X0X7BPJ NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE (NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND HYDROCORTISONE) SUSPENSION/ DROPS [PREFERRED PHARMACEUTICALS, INC.] 2 NEOMYCIN SULFATE ACTIVE INGREDIENT 057Y626693 NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE (NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND HYDROCORTISONE) SUSPENSION/ DROPS [PREFERRED PHARMACEUTICALS, INC.] 2 POLYMYXIN B SULFATE ACTIVE INGREDIENT 19371312D4 NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE (NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND HYDROCORTISONE) SUSPENSION/ DROPS [PREFERRED PHARMACEUTICALS, INC.] 2 HYDROCORTISONE ACTIVE MOIETY WI4X0X7BPJ NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE (NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND HYDROCORTISONE) SUSPENSION/ DROPS [PREFERRED PHARMACEUTICALS, INC.] 2 NEOMYCIN ACTIVE MOIETY I16QD7X297 NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE (NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND HYDROCORTISONE) SUSPENSION/ DROPS [PREFERRED PHARMACEUTICALS, INC.] 2 POLYMYXIN B ACTIVE MOIETY J2VZ07J96K NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE (NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND HYDROCORTISONE) SUSPENSION/ DROPS [PREFERRED PHARMACEUTICALS, INC.] 2 CETYL ALCOHOL INACTIVE INGREDIENT 936JST6JCN NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE (NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND HYDROCORTISONE) SUSPENSION/ DROPS [PREFERRED PHARMACEUTICALS, INC.] 2 POLYSORBATE 80 INACTIVE INGREDIENT 6OZP39ZG8H NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE (NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND HYDROCORTISONE) SUSPENSION/ DROPS [PREFERRED PHARMACEUTICALS, INC.] 2 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE (NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND HYDROCORTISONE) SUSPENSION/ DROPS [PREFERRED PHARMACEUTICALS, INC.] 2 SULFURIC ACID INACTIVE INGREDIENT O40UQP6WCF NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE (NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND HYDROCORTISONE) SUSPENSION/ DROPS [PREFERRED PHARMACEUTICALS, INC.] 2 THIMEROSAL INACTIVE INGREDIENT 2225PI3MOV NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE (NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND HYDROCORTISONE) SUSPENSION/ DROPS [PREFERRED PHARMACEUTICALS, INC.] 2 WATER INACTIVE INGREDIENT 059QF0KO0R NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE (NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND HYDROCORTISONE) SUSPENSION/ DROPS [PREFERRED PHARMACEUTICALS, INC.] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68788-9924 NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE (NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND HYDROCORTISONE) SUSPENSION/ DROPS [PREFERRED PHARMACEUTICALS, INC.] 10 Current NDC, Legacy NDC, 2 package rows 20240724_f8dc2b6f-daf3-4a3a-b31f-b97e2f152eae.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 68788-9924-1 68788992401 1 BOTTLE, DROPPER in 1 CARTON (68788-9924-1) / 10 mL in 1 BOTTLE, DROPPER 2012-01-18 0000-00-00 No No Current