NDC 53002-9061

Neomycin and Polymyxin B Sulfates and Hydrocortisone

Neomycin Sulfate, Polymyxin B Sulfate, Hydrocortisone

Neomycin and Polymyxin B Sulfates and Hydrocortisone is a Auricular (otic) Solution/ Drops in the Human Prescription Drug category. It is labeled and distributed by Rpk Pharmaceuticals, Inc.. The primary component is Neomycin Sulfate; Polymyxin B Sulfate; Hydrocortisone.

• Product ID: 53002-9061_584f9aa4-c3bb-45ae-b48c-f3543026f72e
• NDC: 53002-9061
• Product Type: Human Prescription Drug
• Proprietary Name: Neomycin and Polymyxin B Sulfates and Hydrocortisone
• Generic Name: Neomycin Sulfate, Polymyxin B Sulfate, Hydrocortisone
• Dosage Form: Solution/ Drops
• Route of Administration: AURICULAR (OTIC)
• Marketing Start Date: 1995-12-29
• Marketing Category: ANDA / ANDA
• Application Number: ANDA064053
• Labeler Name: RPK Pharmaceuticals, Inc.
• Substance Name: NEOMYCIN SULFATE; POLYMYXIN B SULFATE; HYDROCORTISONE
• Active Ingredient Strength: 4 mg/mL; [USP'U]/mL; mg/mL
• Pharm Classes: Aminoglycoside Antibacterial [EPC],Aminoglycosides [CS],Polymyxin-class Antibacterial [EPC],Polymyxins [CS],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 53002-9061-1

1 BOTTLE, DROPPER in 1 CARTON (53002-9061-1) > 10 mL in 1 BOTTLE, DROPPER

• Marketing Start Date: 2018-10-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 53002-9061-1 [53002906101]

Neomycin and Polymyxin B Sulfates and Hydrocortisone SOLUTION/ DROPS

• Marketing Category: ANDA
• Application Number: ANDA064053
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2018-10-01
• Inactivation Date: 2020-01-31

Drug Details

Active Ingredients

Ingredient	Strength
NEOMYCIN SULFATE	3.5 mg/mL

OpenFDA Data

• SPL SET ID: 7f616d43-d737-4391-9faa-3f13d3bc96e9
• Manufacturer:
  • RPK Pharmaceuticals, Inc.
• UNII:
  • 19371312D4
  • 057Y626693
  • WI4X0X7BPJ
• RxNorm Concept Unique ID - RxCUI:
  • 204423

Pharmacological Class

• Aminoglycoside Antibacterial [EPC]
• Aminoglycosides [CS]
• Polymyxin-class Antibacterial [EPC]
• Polymyxins [CS]
• Corticosteroid [EPC]
• Corticosteroid Hormone Receptor Agonists [MoA]

NDC Crossover Matching brand name "Neomycin and Polymyxin B Sulfates and Hydrocortisone" or generic name "Neomycin Sulfate, Polymyxin B Sulfate, Hydrocortisone"

NDC	Brand Name	Generic Name
10544-912	Neomycin and Polymyxin B Sulfates and Hydrocortisone	Neomycin Sulfate, Polymyxin B Sulfate, Hydrocortisone
21695-437	Neomycin and Polymyxin B Sulfates and Hydrocortisone	Neomycin Sulfate, Polymyxin B Sulfate, Hydrocortisone
21695-438	Neomycin and Polymyxin B Sulfates and Hydrocortisone	Neomycin sulfate, Polymyxin B Sulfate and Hydrocortisone
24208-631	Neomycin and Polymyxin B Sulfates and Hydrocortisone	Neomycin Sulfate, Polymyxin B Sulfate, Hydrocortisone
24208-635	Neomycin and Polymyxin B Sulfates and Hydrocortisone	Neomycin sulfate, Polymyxin B Sulfate and Hydrocortisone
49999-254	Neomycin and Polymyxin B Sulfates and Hydrocortisone	Neomycin Sulfate, Polymyxin B Sulfate, Hydrocortisone
49999-439	Neomycin and Polymyxin B Sulfates and Hydrocortisone	Neomycin and Polymyxin B Sulfates and Hydrocortisone
50090-0431	Neomycin and Polymyxin B Sulfates and Hydrocortisone	Neomycin sulfate, Polymyxin B Sulfate and Hydrocortisone
50090-0433	Neomycin and Polymyxin B Sulfates and Hydrocortisone	Neomycin Sulfate, Polymyxin B Sulfate, Hydrocortisone
50090-2365	Neomycin and Polymyxin B Sulfates and Hydrocortisone	neomycin sulfate, polymyxin b sulfate and hydrocortisone
50090-2426	Neomycin and Polymyxin B Sulfates and Hydrocortisone	neomycin sulfate, polymyxin b sulfate and hydrocortisone
50436-0737	Neomycin and Polymyxin B Sulfates and Hydrocortisone	Neomycin sulfate, Polymyxin B Sulfate and Hydrocortisone
52959-084	Neomycin and Polymyxin B Sulfates and Hydrocortisone	Neomycin sulfate, Polymyxin B Sulfate and Hydrocortisone
53002-9000	Neomycin and Polymyxin B Sulfates and Hydrocortisone	Neomycin sulfate, Polymyxin B Sulfate and Hydrocortisone
53002-9060	Neomycin and Polymyxin B Sulfates and Hydrocortisone	neomycin sulfate, polymyxin b sulfate and hydrocortisone
53002-9061	Neomycin and Polymyxin B Sulfates and Hydrocortisone	Neomycin Sulfate, Polymyxin B Sulfate, Hydrocortisone
55700-282	Neomycin and Polymyxin B Sulfates and Hydrocortisone	neomycin sulfate, polymyxin b sulfate and hydrocortisone
61314-641	Neomycin and Polymyxin B Sulfates and Hydrocortisone	neomycin sulfate, polymyxin b sulfate and hydrocortisone
61314-645	Neomycin and Polymyxin B Sulfates and Hydrocortisone	neomycin sulfate, polymyxin b sulfate and hydrocortisone
61314-646	Neomycin and Polymyxin B Sulfates and Hydrocortisone	neomycin sulfate, polymyxin b sulfate and hydrocortisone
61919-662	NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE	NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE
63187-270	Neomycin and Polymyxin B Sulfates and Hydrocortisone	Neomycin Sulfate, Polymyxin B Sulfate, Hydrocortisone
63187-308	Neomycin and Polymyxin B Sulfates and Hydrocortisone	Neomycin sulfate, Polymyxin B Sulfate and Hydrocortisone
63187-568	Neomycin and Polymyxin B Sulfates and Hydrocortisone	neomycin sulfate, polymyxin b sulfate and hydrocortisone
63187-648	Neomycin and Polymyxin B Sulfates and Hydrocortisone	neomycin sulfate, polymyxin b sulfate and hydrocortisone
68071-4174	Neomycin and Polymyxin B Sulfates and Hydrocortisone	Neomycin and Polymyxin B Sulfates and Hydrocortisone
68071-4577	Neomycin and Polymyxin B Sulfates and Hydrocortisone	Neomycin and Polymyxin B Sulfates and Hydrocortisone
68071-4229	Neomycin and Polymyxin B Sulfates and Hydrocortisone	Neomycin and Polymyxin B Sulfates and Hydrocortisone
68788-9415	Neomycin and Polymyxin B Sulfates and Hydrocortisone	Neomycin and Polymyxin B Sulfates and Hydrocortisone
68788-9924	Neomycin and Polymyxin B Sulfates and Hydrocortisone	Neomycin and Polymyxin B Sulfates and Hydrocortisone
70518-0763	Neomycin and Polymyxin B Sulfates and Hydrocortisone	Neomycin and Polymyxin B Sulfates and Hydrocortisone
70518-0864	Neomycin and Polymyxin B Sulfates and Hydrocortisone	Neomycin and Polymyxin B Sulfates and Hydrocortisone
76413-117	Neomycin and Polymyxin B Sulfates and Hydrocortisone	Neomycin and Polymyxin B Sulfates and Hydrocortisone
66267-957	Neomycin and Polymyxin B Sulfates and Hydrocortisone	Neomycin and Polymyxin B Sulfates and Hydrocortisone
66267-954	Neomycin and Polymyxin B Sulfates and Hydrocortisone	Neomycin and Polymyxin B Sulfates and Hydrocortisone
68788-7684	Neomycin and Polymyxin B Sulfates and Hydrocortisone	Neomycin and Polymyxin B Sulfates and Hydrocortisone