NDC 0065-0631

MAXITROL

Neomycin Sulfate, Polymyxin B Sulfate And Dexamethasone

MAXITROL is a Ophthalmic Ointment in the Human Prescription Drug category. It is labeled and distributed by Alcon Laboratories, Inc.. The primary component is Neomycin Sulfate; Polymyxin B Sulfate; Dexamethasone.

• Product ID: 0065-0631_3ced924b-13a5-4107-9b87-d7fb7f80d199
• NDC: 0065-0631
• Product Type: Human Prescription Drug
• Proprietary Name: MAXITROL
• Generic Name: Neomycin Sulfate, Polymyxin B Sulfate And Dexamethasone
• Dosage Form: Ointment
• Route of Administration: OPHTHALMIC
• Marketing Start Date: 1972-01-17
• Marketing Category: NDA / NDA
• Application Number: NDA050065
• Labeler Name: Alcon Laboratories, Inc.
• Substance Name: NEOMYCIN SULFATE; POLYMYXIN B SULFATE; DEXAMETHASONE
• Active Ingredient Strength: 4 mg/g; [USP'U]/g; mg/g
• Pharm Classes: Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA],Aminoglycoside Antibacterial [EPC],Aminoglycosides [CS],Polymyxin-class Antibacterial [EPC],Polymyxins [CS]
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 0065-0631-36

3.5 g in 1 TUBE (0065-0631-36)

• Marketing Start Date: 1972-01-17
• Marketing End Date: 2024-05-31
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0065-0631-36 [00065063136]

MAXITROL OINTMENT

• Marketing Category: NDA
• Application Number: NDA050065
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: GM
• Marketing Start Date: 1972-01-17

Drug Details

Active Ingredients

Ingredient	Strength
NEOMYCIN SULFATE	3.5 mg/g

OpenFDA Data

• SPL SET ID: d17cecdb-c7cb-41cc-a11e-00c6ed0dcc11
• Manufacturer:
  • Alcon Laboratories, Inc.
• UNII:
  • 7S5I7G3JQL
  • 19371312D4
  • 057Y626693
• RxNorm Concept Unique ID - RxCUI:
  • 309679
  • 208601
• UPC Code:
  • 0300650631365

Pharmacological Class

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

NDC Crossover Matching brand name "MAXITROL" or generic name "Neomycin Sulfate, Polymyxin B Sulfate And Dexamethasone"

NDC	Brand Name	Generic Name
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
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
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