NDC 13985-608

Neomycin and Polymyxin B Sulfates, Bacitracin Zinc, and Hydrocortisone

Neomycin Sulfate, Polymyxin B Sulfate, Bacitracin Zinc And Hydrocortisone

Neomycin and Polymyxin B Sulfates, Bacitracin Zinc, and Hydrocortisone is a Ophthalmic Ointment in the Human Prescription Drug category. It is labeled and distributed by Mwi. The primary component is Neomycin Sulfate; Polymyxin B Sulfate; Bacitracin Zinc; Hydrocortisone.

• Product ID: 13985-608_21eff6b1-77fb-41e3-bebe-f128df73860e
• NDC: 13985-608
• Product Type: Human Prescription Drug
• Proprietary Name: Neomycin and Polymyxin B Sulfates, Bacitracin Zinc, and Hydrocortisone
• Generic Name: Neomycin Sulfate, Polymyxin B Sulfate, Bacitracin Zinc And Hydrocortisone
• Dosage Form: Ointment
• Route of Administration: OPHTHALMIC
• Marketing Start Date: 2015-03-23
• Marketing Category: ANDA / ANDA
• Application Number: ANDA065213
• Labeler Name: MWI
• Substance Name: NEOMYCIN SULFATE; POLYMYXIN B SULFATE; BACITRACIN ZINC; HYDROCORTISONE
• Active Ingredient Strength: 4 mg/g; [USP'U]/g; [USP'U]/g; mg/g
• Pharm 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: N
• Listing Certified Through: 2021-12-31

Packaging

NDC 13985-608-03

1 TUBE in 1 CARTON (13985-608-03) > 3.5 g in 1 TUBE

• Marketing Start Date: 2015-03-23
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 13985-608-03 [13985060803]

Neomycin and Polymyxin B Sulfates, Bacitracin Zinc, and Hydrocortisone OINTMENT

• Marketing Category: ANDA
• Application Number: ANDA065213
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2015-03-23

Drug Details

Active Ingredients

Ingredient	Strength
NEOMYCIN SULFATE	3.5 mg/g

OpenFDA Data

• SPL SET ID: f914f577-32aa-4b7a-9996-ca24b34f022d
• Manufacturer:
  • MWI
• UNII:
  • 89Y4M234ES
  • 19371312D4
  • 057Y626693
  • WI4X0X7BPJ
• RxNorm Concept Unique ID - RxCUI:
  • 1116150
• UPC Code:
  • 0313985012570

Pharmacological Class

• Aminoglycoside Antibacterial [EPC]
• Aminoglycosides [CS]
• Polymyxin-class Antibacterial [EPC]
• Polymyxins [CS]
• Decreased Cell Wall Synthesis & Repair [PE]
• Corticosteroid [EPC]
• Corticosteroid Hormone Receptor Agonists [MoA]
• 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 Crossover Matching brand name "Neomycin and Polymyxin B Sulfates, Bacitracin Zinc, and Hydrocortisone" or generic name "Neomycin Sulfate, Polymyxin B Sulfate, Bacitracin Zinc And Hydrocortisone"

NDC	Brand Name	Generic Name
0404-7195	Neomycin and Polymyxin B Sulfates, Bacitracin Zinc, and Hydrocortisone	Neomycin Sulfate, Polymyxin B Sulfate, Bacitracin Zinc and Hydrocortisone
13985-608	Neomycin and Polymyxin B Sulfates, Bacitracin Zinc, and Hydrocortisone	Neomycin Sulfate, Polymyxin B Sulfate, Bacitracin Zinc and Hydrocortisone
17478-719	Neomycin and Polymyxin B Sulfates, Bacitracin Zinc, and Hydrocortisone	Neomycin Sulfate, Polymyxin B Sulfate, Bacitracin Zinc, Hydrocortisone
61570-031	CORTISPORIN	neomycin and polymyxin B sulfates, bacitracin zinc, and hydrocortisone