Home NDC 52959-084 Neomycin and Polymyxin B Sulfates and Hydrocortisone
Product NDC 52959-084
11-digit product format 529590084
Labeler code 52959
Product ID 52959-084_36912c86-f160-4e1b-8fef-a0552745e1c3
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Neomycin sulfate, Polymyxin B Sulfate and Hydrocortisone
Dosage form SUSPENSION/ DROPS
Route AURICULAR (OTIC)
Labeler H.J. Harkins Company, Inc.
Application ANDA064065
Marketing category ANDA
Marketing start 1996-08-28
Marketing end 0000-00-00
Substance HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE
Active strength 10 mg/mL; mg/mL; [USP'U]/mL
Pharmacologic classes Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA],Aminoglycoside Antibacterial [EPC],Aminoglycosides [CS],Polymyxin-class Antibacterial [EPC],Polymyxins [CS]
NDC exclude flag E
Listing certified through 2017-12-31
Current FDA listing Historical FDA.report record 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 52959-084-00 Neomycin and Polymyxin B Sulfates and Hydrocortisone 10 mL in 1 BOTTLE, DROPPER SUSPENSION/ DROPS 10 5
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 [H.J. HARKINS COMPANY, INC.] 5 NEOMYCIN SULFATE ACTIVE INGREDIENT 057Y626693 NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE (NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND HYDROCORTISONE) SUSPENSION/ DROPS [H.J. HARKINS COMPANY, INC.] 5 POLYMYXIN B SULFATE ACTIVE INGREDIENT 19371312D4 NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE (NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND HYDROCORTISONE) SUSPENSION/ DROPS [H.J. HARKINS COMPANY, INC.] 5 HYDROCORTISONE ACTIVE MOIETY WI4X0X7BPJ NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE (NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND HYDROCORTISONE) SUSPENSION/ DROPS [H.J. HARKINS COMPANY, INC.] 5 NEOMYCIN ACTIVE MOIETY I16QD7X297 NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE (NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND HYDROCORTISONE) SUSPENSION/ DROPS [H.J. HARKINS COMPANY, INC.] 5 POLYMYXIN B ACTIVE MOIETY J2VZ07J96K NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE (NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND HYDROCORTISONE) SUSPENSION/ DROPS [H.J. HARKINS COMPANY, INC.] 5 CETYL ALCOHOL INACTIVE INGREDIENT 936JST6JCN NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE (NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND HYDROCORTISONE) SUSPENSION/ DROPS [H.J. HARKINS COMPANY, INC.] 5 POLYSORBATE 80 INACTIVE INGREDIENT 6OZP39ZG8H NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE (NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND HYDROCORTISONE) SUSPENSION/ DROPS [H.J. HARKINS COMPANY, INC.] 5 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE (NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND HYDROCORTISONE) SUSPENSION/ DROPS [H.J. HARKINS COMPANY, INC.] 5 SULFURIC ACID INACTIVE INGREDIENT O40UQP6WCF NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE (NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND HYDROCORTISONE) SUSPENSION/ DROPS [H.J. HARKINS COMPANY, INC.] 5 THIMEROSAL INACTIVE INGREDIENT 2225PI3MOV NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE (NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND HYDROCORTISONE) SUSPENSION/ DROPS [H.J. HARKINS COMPANY, INC.] 5 WATER INACTIVE INGREDIENT 059QF0KO0R NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE (NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND HYDROCORTISONE) SUSPENSION/ DROPS [H.J. HARKINS COMPANY, INC.] 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 52959-084 NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE (NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND HYDROCORTISONE) SUSPENSION/ DROPS [H.J. HARKINS COMPANY, INC.] 5 Legacy NDC, 1 package rows 20120423_02b16b3c-5276-4c5c-affa-9e08d99667b0.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Status 52959-084-00 52959008400 10 mL in 1 BOTTLE, DROPPER 10 ml Historical