Home NDC 53002-9000 Neomycin and Polymyxin B Sulfates and Hydrocortisone
Product NDC 53002-9000
11-digit product format 530029000
Labeler code 53002
Product ID 53002-9000_c56fe71a-1b27-40af-b27a-ab518842f78d
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Neomycin sulfate, Polymyxin B Sulfate and Hydrocortisone
Dosage form SUSPENSION/ DROPS
Route AURICULAR (OTIC)
Labeler RPK Pharmaceuticals, 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 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 53002-9000-1 Neomycin and Polymyxin B Sulfates and Hydrocortisone 1 in 1 CARTON SUSPENSION/ DROPS 1 5 53002-9000-1 Neomycin and Polymyxin B Sulfates and Hydrocortisone 10 mL in 1 BOTTLE, DROPPER SUSPENSION/ DROPS 10 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 53002-9000 NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE (NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND HYDROCORTISONE) SUSPENSION/ DROPS [RPK PHARMACEUTICALS, INC.] 5 Legacy NDC, 2 package rows 20230609_5f0ea0c7-e064-4b54-83bc-a9f8f8d6ec5a.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 53002-9000-1 53002900001 1 BOTTLE, DROPPER in 1 CARTON (53002-9000-1) > 10 mL in 1 BOTTLE, DROPPER 2017-10-01 0000-00-00 No No Current