Home NDC 13985-016 Neomycin and Polymyxin B Sulfates, Bacitracin Zinc and Hydrocortisone
Product NDC 13985-016
11-digit product format 139850016
Labeler code 13985
Product ID 13985-016_10195234-e8c4-455a-9e27-0333f454ea3f
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Neomycin sulfate and Polymyxin B Sulfate, Bacitracin Zinc and Hydrocortisone
Dosage form OINTMENT
Route OPHTHALMIC
Labeler MWI/VetOne
Application ANDA064068
Marketing category ANDA
Marketing start 1995-10-30
Marketing end 0000-00-00
Substance NEOMYCIN SULFATE; POLYMYXIN B SULFATE; BACITRACIN ZINC; HYDROCORTISONE
Active strength 4 mg/g; [USP'U]/g; [USP'U]/g; mg/g
Pharmacologic classes Aminoglycoside Antibacterial [EPC],Aminoglycosides [CS],Polymyxin-class Antibacterial [EPC],Polymyxins [CS],Decreased Cell Wall Synthesis & Repair [PE],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
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 13985-016-55 Neomycin and Polymyxin B Sulfates, Bacitracin Zinc and Hydrocortisone 3.5 g in 1 TUBE OINTMENT 3.5 1 13985-016-55 Neomycin and Polymyxin B Sulfates, Bacitracin Zinc and Hydrocortisone 1 in 1 CARTON OINTMENT 1 1
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 AND POLYMYXIN B SULFATE, BACITRACIN ZINC AND HYDROCORTISONE) OINTMENT [MWI/VETONE] 1 HYDROCORTISONE ACTIVE INGREDIENT WI4X0X7BPJ NEOMYCIN AND POLYMYXIN B SULFATES, BACITRACIN ZINC AND HYDROCORTISONE (NEOMYCIN SULFATE AND POLYMYXIN B SULFATE, BACITRACIN ZINC AND HYDROCORTISONE) OINTMENT [MWI/VETONE] 1 NEOMYCIN SULFATE ACTIVE INGREDIENT 057Y626693 NEOMYCIN AND POLYMYXIN B SULFATES, BACITRACIN ZINC AND HYDROCORTISONE (NEOMYCIN SULFATE AND POLYMYXIN B SULFATE, BACITRACIN ZINC AND HYDROCORTISONE) OINTMENT [MWI/VETONE] 1 POLYMYXIN B SULFATE ACTIVE INGREDIENT 19371312D4 NEOMYCIN AND POLYMYXIN B SULFATES, BACITRACIN ZINC AND HYDROCORTISONE (NEOMYCIN SULFATE AND POLYMYXIN B SULFATE, BACITRACIN ZINC AND HYDROCORTISONE) OINTMENT [MWI/VETONE] 1 BACITRACIN ACTIVE MOIETY 58H6RWO52I NEOMYCIN AND POLYMYXIN B SULFATES, BACITRACIN ZINC AND HYDROCORTISONE (NEOMYCIN SULFATE AND POLYMYXIN B SULFATE, BACITRACIN ZINC AND HYDROCORTISONE) OINTMENT [MWI/VETONE] 1 HYDROCORTISONE ACTIVE MOIETY WI4X0X7BPJ NEOMYCIN AND POLYMYXIN B SULFATES, BACITRACIN ZINC AND HYDROCORTISONE (NEOMYCIN SULFATE AND POLYMYXIN B SULFATE, BACITRACIN ZINC AND HYDROCORTISONE) OINTMENT [MWI/VETONE] 1 NEOMYCIN ACTIVE MOIETY I16QD7X297 NEOMYCIN AND POLYMYXIN B SULFATES, BACITRACIN ZINC AND HYDROCORTISONE (NEOMYCIN SULFATE AND POLYMYXIN B SULFATE, BACITRACIN ZINC AND HYDROCORTISONE) OINTMENT [MWI/VETONE] 1 POLYMYXIN B ACTIVE MOIETY J2VZ07J96K NEOMYCIN AND POLYMYXIN B SULFATES, BACITRACIN ZINC AND HYDROCORTISONE (NEOMYCIN SULFATE AND POLYMYXIN B SULFATE, BACITRACIN ZINC AND HYDROCORTISONE) OINTMENT [MWI/VETONE] 1 MINERAL OIL INACTIVE INGREDIENT T5L8T28FGP NEOMYCIN AND POLYMYXIN B SULFATES, BACITRACIN ZINC AND HYDROCORTISONE (NEOMYCIN SULFATE AND POLYMYXIN B SULFATE, BACITRACIN ZINC AND HYDROCORTISONE) OINTMENT [MWI/VETONE] 1 PETROLATUM INACTIVE INGREDIENT 4T6H12BN9U NEOMYCIN AND POLYMYXIN B SULFATES, BACITRACIN ZINC AND HYDROCORTISONE (NEOMYCIN SULFATE AND POLYMYXIN B SULFATE, BACITRACIN ZINC AND HYDROCORTISONE) OINTMENT [MWI/VETONE] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 13985-016 NEOMYCIN AND POLYMYXIN B SULFATES, BACITRACIN ZINC AND HYDROCORTISONE (NEOMYCIN SULFATE AND POLYMYXIN B SULFATE, BACITRACIN ZINC AND HYDROCORTISONE) OINTMENT [MWI/VETONE] 1 Legacy NDC, 2 package rows 20101202_10195234-e8c4-455a-9e27-0333f454ea3f.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Status 13985-016-55 13985001655 3.5 g in 1 TUBE 3.5 g Historical