Cortisporin-TC

Basic Information

Product Name

Cortisporin-TC

FDA Product Code

54868-0564

Regulatory Information

NDC Product Code

54868-0564

Application Number

NDA050356

Marketing Category

C73594

Effective Date

December 30, 2010

Territorial Authority

USA

FDA Title

Cortisporin-TC Otic Suspension with Neomycin and Hydrocortisone (colistin sulfate—neomycin sulfate—thonzonium bromide—hydrocortisone acetate otic suspension)

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

Active Ingredients

COLISTIN SULFATE

Quantity: 3 mg in 1 mL

Code: WP15DXU577

Class Code: ACTIM

NEOMYCIN SULFATE

Quantity: 3.3 mg in 1 mL

Code: 057Y626693

Class Code: ACTIM

POLYSORBATE 80

Code: 6OZP39ZG8H

Class Code: IACT

THONZONIUM BROMIDE

Quantity: 0.5 mg in 1 mL

Code: JI2B19CR0R

Class Code: ACTIM

HYDROCORTISONE ACETATE

Quantity: 10 mg in 1 mL

Code: 3X7931PO74

Class Code: ACTIM

ACETIC ACID

Code: Q40Q9N063P

Class Code: IACT

SODIUM ACETATE

Code: 4550K0SC9B

Class Code: IACT

Active Moieties

THONZONIUM BROMIDE

Code: JI2B19CR0R

COLISTIN

Code: Z67X93HJG1

NEOMYCIN

Code: I16QD7X297

HYDROCORTISONE

Code: WI4X0X7BPJ

Basic Information

Regulatory Information

Company Information

Active Ingredients

POLYSORBATE 80

ACETIC ACID

SODIUM ACETATE

Active Moieties

THONZONIUM BROMIDE

COLISTIN

NEOMYCIN

HYDROCORTISONE