NDC 53002-9510

Neomycin Polymyxin B Sulfates and Dexamethasone

Neomycin Sulfate, Polymyxin B Sulfate And Dexamethasone

Neomycin Polymyxin B Sulfates and Dexamethasone is a Ophthalmic Suspension/ 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; Dexamethasone.

• Product ID: 53002-9510_a1cf530d-7946-4712-b4f0-d8e5631a11a5
• NDC: 53002-9510
• Product Type: Human Prescription Drug
• Proprietary Name: Neomycin Polymyxin B Sulfates and Dexamethasone
• Generic Name: Neomycin Sulfate, Polymyxin B Sulfate And Dexamethasone
• Dosage Form: Suspension/ Drops
• Route of Administration: OPHTHALMIC
• Marketing Start Date: 1995-09-13
• Marketing Category: ANDA / ANDA
• Application Number: ANDA064135
• Labeler Name: RPK Pharmaceuticals, Inc.
• Substance Name: NEOMYCIN SULFATE; POLYMYXIN B SULFATE; DEXAMETHASONE
• 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: 2021-12-31

Packaging

NDC 53002-9510-1

5 mL in 1 BOTTLE, DROPPER (53002-9510-1)

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

NDC SPL Data Element Entries

NDC 53002-9510-1 [53002951001]

Neomycin Polymyxin B Sulfates and Dexamethasone SUSPENSION/ DROPS

• Marketing Category: ANDA
• Application Number: ANDA064135
• 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: 1a5eb12f-7a07-405b-aa0f-7a2e1a197c4d
• Manufacturer:
  • RPK Pharmaceuticals, Inc.
• UNII:
  • 7S5I7G3JQL
  • 19371312D4
  • 057Y626693
• RxNorm Concept Unique ID - RxCUI:
  • 309680

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 Polymyxin B Sulfates and Dexamethasone" or generic name "Neomycin Sulfate, Polymyxin B Sulfate And Dexamethasone"

NDC	Brand Name	Generic Name
13985-028	Neomycin Polymyxin B Sulfates and Dexamethasone	Neomycin sulfate, Polymyxin B Sulfate and Dexamethasone
24208-830	Neomycin Polymyxin B Sulfates and Dexamethasone	Neomycin sulfate, Polymyxin B Sulfate and Dexamethasone
45865-796	Neomycin Polymyxin B Sulfates and Dexamethasone	Neomycin sulfate, Polymyxin B Sulfate and Dexamethasone
50090-0570	Neomycin Polymyxin B Sulfates and Dexamethasone	Neomycin sulfate, Polymyxin B Sulfate and Dexamethasone
52959-085	Neomycin Polymyxin B Sulfates and Dexamethasone	Neomycin sulfate, Polymyxin B Sulfate and Dexamethasone
53002-9510	Neomycin Polymyxin B Sulfates and Dexamethasone	Neomycin sulfate, Polymyxin B Sulfate and Dexamethasone
57319-347	Neomycin Polymyxin B Sulfates and Dexamethasone	Neomycin sulfate, Polymyxin B Sulfate and Dexamethasone
61919-167	NEOMYCIN POLYMYXIN B SULFATES AND DEXAMETHASONE	NEOMYCIN POLYMYXIN B SULFATES AND DEXAMETHASONE
63187-498	Neomycin Polymyxin B Sulfates and Dexamethasone	Neomycin sulfate, Polymyxin B Sulfate and Dexamethasone
66267-958	Neomycin Polymyxin B Sulfates and Dexamethasone	Neomycin sulfate, Polymyxin B Sulfate and Dexamethasone
68071-4375	Neomycin Polymyxin B Sulfates and Dexamethasone	Neomycin sulfate, Polymyxin B Sulfate and Dexamethasone
68788-9702	Neomycin Polymyxin B Sulfates and Dexamethasone	Neomycin sulfate, Polymyxin B Sulfate and Dexamethasone
0065-0631	MAXITROL	neomycin sulfate, polymyxin b sulfate and dexamethasone
0078-0771	MAXITROL	neomycin sulfate, polymyxin b sulfate and dexamethasone
0078-0792	Maxitrol	neomycin sulfate, polymyxin b sulfate and dexamethasone
0998-0630	Maxitrol	neomycin sulfate, polymyxin b sulfate and dexamethasone
11695-1403	NEO-POLY-DEX	Neomycin sulfate, Polymyxin B Sulfate and Dexamethasone
21695-595	Neomycin and Polymyxin B Sulfates and Dexamethasone	neomycin sulfate, polymyxin B sulfate and dexamethasone
33261-551	Neomycin and Polymyxin B Sulfates and Dexamethasone	neomycin sulfate, polymyxin b sulfate and dexamethasone
49999-141	Neomycin and Polymyxin B Sulfates and Dexamethasone	neomycin sulfate, polymyxin b sulfate and dexamethasone
50090-1957	Neomycin and Polymyxin B Sulfates and Dexamethasone	neomycin sulfate, polymyxin b sulfate and dexamethasone
50090-3068	Neomycin and Polymyxin B Sulfates and Dexamethasone	neomycin sulfate, polymyxin b sulfate and dexamethasone
53002-9511	Neomycin and Polymyxin B Sulfates and Dexamethasone	neomycin sulfate, polymyxin b sulfate and dexamethasone
61314-630	Neomycin and Polymyxin B Sulfates and Dexamethasone	neomycin sulfate, polymyxin b sulfate and dexamethasone
68071-3359	Neomycin and Polymyxin B Sulfates and Dexamethasone	neomycin sulfate, polymyxin b sulfate and dexamethasone
68788-7686	Neomycin and Polymyxin B Sulfates and Dexamethasone	neomycin sulfate, polymyxin b sulfate and dexamethasone
68788-9120	Neomycin and Polymyxin B Sulfates and Dexamethasone	neomycin sulfate, polymyxin b sulfate and dexamethasone