Home NDC 53002-9061 Neomycin and Polymyxin B Sulfates and Hydrocortisone
Product NDC 53002-9061
11-digit product format 530029061
Labeler code 53002
Product ID 53002-9061_f800c7e8-a7f5-4be3-ad8b-3a5d2fa35e99
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Neomycin Sulfate, Polymyxin B Sulfate, Hydrocortisone
Dosage form SOLUTION/ DROPS
Route AURICULAR (OTIC)
Labeler RPK Pharmaceuticals, Inc.
Application ANDA064053
Marketing category ANDA
Marketing start 1995-12-29
Marketing end 0000-00-00
Substance NEOMYCIN SULFATE; POLYMYXIN B SULFATE; HYDROCORTISONE
Active strength 4 mg/mL; [USP'U]/mL; mg/mL
Pharmacologic classes Aminoglycoside Antibacterial [EPC],Aminoglycosides [CS],Polymyxin-class Antibacterial [EPC],Polymyxins [CS],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC exclude flag No
Listing certified through 2021-12-31
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 53002-9061-1 Neomycin and Polymyxin B Sulfates and Hydrocortisone 10 mL in 1 BOTTLE, DROPPER SOLUTION/ DROPS 10 5 53002-9061-1 Neomycin and Polymyxin B Sulfates and Hydrocortisone 1 in 1 CARTON SOLUTION/ DROPS 1 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 53002-9061 NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE (NEOMYCIN SULFATE, POLYMYXIN B SULFATE, HYDROCORTISONE) SOLUTION/ DROPS [RPK PHARMACEUTICALS, INC.] 5 Legacy NDC, 2 package rows 20230609_7f616d43-d737-4391-9faa-3f13d3bc96e9.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 53002-9061-1 53002906101 1 BOTTLE, DROPPER in 1 CARTON (53002-9061-1) > 10 mL in 1 BOTTLE, DROPPER 2018-10-01 0000-00-00 No No Current