Home NDC 17478-719 Neomycin and Polymyxin B Sulfates, Bacitracin Zinc, and Hydrocortisone
Product NDC 17478-719
11-digit product format 174780719
Labeler code 17478
Product ID 17478-719_4eb947c7-2da9-4ce6-8d13-06a4539a6e96
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Neomycin Sulfate, Polymyxin B Sulfate, Bacitracin Zinc, Hydrocortisone
Dosage form OINTMENT
Route OPHTHALMIC
Labeler Akorn
Application ANDA065213
Marketing category ANDA
Marketing start 2012-07-25
Marketing end 0000-00-00
Substance BACITRACIN ZINC; HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE
Active strength 400 [USP'U]/g; mg/g; mg/g; [USP'U]/g
Pharmacologic classes Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]
NDC exclude flag No
Listing certified through 2023-12-31
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 17478-719-35 Neomycin and Polymyxin B Sulfates, Bacitracin Zinc, and Hydrocortisone 3.5 g in 1 TUBE OINTMENT 3.5 5 17478-719-35 Neomycin and Polymyxin B Sulfates, Bacitracin Zinc, and Hydrocortisone 1 in 1 CARTON OINTMENT 1 5
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Bacitracin Zinc ACTIVE INGREDIENT 89Y4M234ES NEOMYCIN AND POLYMYXIN B SULFATES, BACITRACIN ZINC, AND HYDROCORTISONE (NEOMYCIN SULFATE, POLYMYXIN B SULFATE, BACITRACIN ZINC, HYDROCORTISONE) OINTMENT [AKORN, INC.] 1 Hydrocortisone ACTIVE INGREDIENT WI4X0X7BPJ NEOMYCIN AND POLYMYXIN B SULFATES, BACITRACIN ZINC, AND HYDROCORTISONE (NEOMYCIN SULFATE, POLYMYXIN B SULFATE, BACITRACIN ZINC, HYDROCORTISONE) OINTMENT [AKORN, INC.] 1 Neomycin Sulfate ACTIVE INGREDIENT 057Y626693 NEOMYCIN AND POLYMYXIN B SULFATES, BACITRACIN ZINC, AND HYDROCORTISONE (NEOMYCIN SULFATE, POLYMYXIN B SULFATE, BACITRACIN ZINC, HYDROCORTISONE) OINTMENT [AKORN, INC.] 1 Polymyxin B Sulfate ACTIVE INGREDIENT 19371312D4 NEOMYCIN AND POLYMYXIN B SULFATES, BACITRACIN ZINC, AND HYDROCORTISONE (NEOMYCIN SULFATE, POLYMYXIN B SULFATE, BACITRACIN ZINC, HYDROCORTISONE) OINTMENT [AKORN, INC.] 1 bacitracin ACTIVE MOIETY 58H6RWO52I NEOMYCIN AND POLYMYXIN B SULFATES, BACITRACIN ZINC, AND HYDROCORTISONE (NEOMYCIN SULFATE, POLYMYXIN B SULFATE, BACITRACIN ZINC, HYDROCORTISONE) OINTMENT [AKORN, INC.] 1 Hydrocortisone ACTIVE MOIETY WI4X0X7BPJ NEOMYCIN AND POLYMYXIN B SULFATES, BACITRACIN ZINC, AND HYDROCORTISONE (NEOMYCIN SULFATE, POLYMYXIN B SULFATE, BACITRACIN ZINC, HYDROCORTISONE) OINTMENT [AKORN, INC.] 1 neomycin ACTIVE MOIETY I16QD7X297 NEOMYCIN AND POLYMYXIN B SULFATES, BACITRACIN ZINC, AND HYDROCORTISONE (NEOMYCIN SULFATE, POLYMYXIN B SULFATE, BACITRACIN ZINC, HYDROCORTISONE) OINTMENT [AKORN, INC.] 1 Polymyxin B ACTIVE MOIETY J2VZ07J96K NEOMYCIN AND POLYMYXIN B SULFATES, BACITRACIN ZINC, AND HYDROCORTISONE (NEOMYCIN SULFATE, POLYMYXIN B SULFATE, BACITRACIN ZINC, HYDROCORTISONE) OINTMENT [AKORN, INC.] 1 Petrolatum INACTIVE INGREDIENT 4T6H12BN9U NEOMYCIN AND POLYMYXIN B SULFATES, BACITRACIN ZINC, AND HYDROCORTISONE (NEOMYCIN SULFATE, POLYMYXIN B SULFATE, BACITRACIN ZINC, HYDROCORTISONE) OINTMENT [AKORN, INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 17478-719 NEOMYCIN AND POLYMYXIN B SULFATES, BACITRACIN ZINC, AND HYDROCORTISONE (NEOMYCIN SULFATE, POLYMYXIN B SULFATE, BACITRACIN ZINC, HYDROCORTISONE) OINTMENT [AKORN] 5 Legacy NDC, 2 package rows 20220204_ce7ded34-66ab-4b6d-a9d7-fcf0c8d86eaa.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 17478-719-35 17478071935 1 TUBE in 1 CARTON (17478-719-35) > 3.5 g in 1 TUBE 1 tube 2012-07-25 0000-00-00 No No Current