Home NDC 53002-9510 Neomycin Polymyxin B Sulfates and Dexamethasone
Product NDC 53002-9510
11-digit product format 530029510
Labeler code 53002
Product ID 53002-9510_a1cf530d-7946-4712-b4f0-d8e5631a11a5
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Neomycin sulfate, Polymyxin B Sulfate and Dexamethasone
Dosage form SUSPENSION/ DROPS
Route OPHTHALMIC
Labeler RPK Pharmaceuticals, Inc.
Application ANDA064135
Marketing category ANDA
Marketing start 1995-09-13
Marketing end 0000-00-00
Substance NEOMYCIN SULFATE; POLYMYXIN B SULFATE; DEXAMETHASONE
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 53002-9510-1 Neomycin Polymyxin B Sulfates and Dexamethasone 5 mL in 1 BOTTLE, DROPPER SUSPENSION/ DROPS 5 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 53002-9510 NEOMYCIN POLYMYXIN B SULFATES AND DEXAMETHASONE (NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND DEXAMETHASONE) SUSPENSION/ DROPS [RPK PHARMACEUTICALS, INC.] 5 Legacy NDC, 1 package rows 20230609_1a5eb12f-7a07-405b-aa0f-7a2e1a197c4d.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 53002-9510-1 53002951001 5 mL in 1 BOTTLE, DROPPER (53002-9510-1) 5 ml 2018-10-01 0000-00-00 No No Current