Home NDC 21695-438 Neomycin and Polymyxin B Sulfates and Hydrocortisone
Product NDC 21695-438
11-digit product format 216950438
Labeler code 21695
Product ID 21695-438_595ee3ac-2f33-4459-87ff-be002928059c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Neomycin sulfate, Polymyxin B Sulfate and Hydrocortisone
Dosage form SUSPENSION/ DROPS
Route AURICULAR (OTIC)
Labeler Rebel Distributors Corp
Application ANDA064053
Marketing category ANDA
Marketing start 1995-12-29
Marketing end 0000-00-00
Substance HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE
Active strength 10 mg/mL; mg/mL; mg/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 21695-438-10 Neomycin and Polymyxin B Sulfates and Hydrocortisone 10 mL in 1 BOTTLE, DROPPER SUSPENSION/ DROPS 10 1 21695-438-10 Neomycin and Polymyxin B Sulfates and Hydrocortisone 1 in 1 CARTON SUSPENSION/ DROPS 1 1
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 [REBEL DISTRIBUTORS CORP] 1 NEOMYCIN SULFATE ACTIVE INGREDIENT 057Y626693 NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE (NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND HYDROCORTISONE) SUSPENSION/ DROPS [REBEL DISTRIBUTORS CORP] 1 POLYMYXIN B SULFATE ACTIVE INGREDIENT 19371312D4 NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE (NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND HYDROCORTISONE) SUSPENSION/ DROPS [REBEL DISTRIBUTORS CORP] 1 HYDROCORTISONE ACTIVE MOIETY WI4X0X7BPJ NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE (NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND HYDROCORTISONE) SUSPENSION/ DROPS [REBEL DISTRIBUTORS CORP] 1 NEOMYCIN ACTIVE MOIETY I16QD7X297 NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE (NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND HYDROCORTISONE) SUSPENSION/ DROPS [REBEL DISTRIBUTORS CORP] 1 POLYMYXIN B ACTIVE MOIETY J2VZ07J96K NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE (NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND HYDROCORTISONE) SUSPENSION/ DROPS [REBEL DISTRIBUTORS CORP] 1 cetyl alcohol INACTIVE INGREDIENT 936JST6JCN NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE (NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND HYDROCORTISONE) SUSPENSION/ DROPS [REBEL DISTRIBUTORS CORP] 1 POLYSORBATE 80 INACTIVE INGREDIENT 6OZP39ZG8H NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE (NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND HYDROCORTISONE) SUSPENSION/ DROPS [REBEL DISTRIBUTORS CORP] 1 propylene glycol INACTIVE INGREDIENT 6DC9Q167V3 NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE (NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND HYDROCORTISONE) SUSPENSION/ DROPS [REBEL DISTRIBUTORS CORP] 1 sulfuric acid INACTIVE INGREDIENT O40UQP6WCF NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE (NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND HYDROCORTISONE) SUSPENSION/ DROPS [REBEL DISTRIBUTORS CORP] 1 thimerosal INACTIVE INGREDIENT 2225PI3MOV NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE (NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND HYDROCORTISONE) SUSPENSION/ DROPS [REBEL DISTRIBUTORS CORP] 1 water INACTIVE INGREDIENT 059QF0KO0R NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE (NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND HYDROCORTISONE) SUSPENSION/ DROPS [REBEL DISTRIBUTORS CORP] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 21695-438 NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE (NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND HYDROCORTISONE) SUSPENSION/ DROPS [REBEL DISTRIBUTORS CORP] 1 Legacy NDC, 2 package rows 20101123_595ee3ac-2f33-4459-87ff-be002928059c.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Status 21695-438-10 21695043810 10 mL in 1 BOTTLE, DROPPER 10 ml Historical