Home NDC 68071-4229 Neomycin and Polymyxin B Sulfates and Hydrocortisone
Product NDC 68071-4229
11-digit product format 680714229
Labeler code 68071
Product ID 68071-4229_27d87c0b-26a3-1aa2-e063-6394a90a027b
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Neomycin sulfate, Polymyxin B Sulfate and Hydrocortisone
Dosage form SUSPENSION/ DROPS
Route AURICULAR (OTIC)
Labeler NuCare Pharmaceuticals,Inc.
Application ANDA064065
Marketing category ANDA
Marketing start 1996-08-28
Substance HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE
Active strength 10; 3.5; 10000 mg/mL; mg/mL; [USP'U]/mL
Pharmacologic classes Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Additional Listing Data#
Finished product Yes
Brand name base Neomycin and Polymyxin B Sulfates and Hydrocortisone
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength HYDROCORTISONE 10 mg/mL NEOMYCIN SULFATE 3.5 mg/mL POLYMYXIN B SULFATE 10000 [USP'U]/mL
Harmonized Identifiers# Field, Values table Field Values Unii WI4X0X7BPJ, 057Y626693, 19371312D4 Rxcui 310687
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 68071-4229-1 Neomycin and Polymyxin B Sulfates and Hydrocortisone 10 mL in 1 BOX SUSPENSION/ DROPS 10 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68071-4229 NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE (NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND HYDROCORTISONE) SUSPENSION/ DROPS [NUCARE PHARMACEUTICALS,INC.] 7 Current NDC, Legacy NDC, 1 package rows 20241127_6296e2ed-336b-b9af-e053-2991aa0aae0c.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 68071-4229-1 68071422901 10 mL in 1 BOX (68071-4229-1) 10 ml 2018-01-12 0000-00-00 No No Current