Cortisporin TC

Basic Information

Product Name

Cortisporin TC

FDA Product Code

63481-529

Regulatory Information

NDC Product Code

63481-529

Application Number

NDA050356

Marketing Category

C73594

Effective Date

April 30, 2019

Territorial Authority

USA

FDA Title

(colistin sulfate—neomycin sulfate—thonzonium bromide—hydrocortisone acetate otic suspension)

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

Active Ingredients

SODIUM ACETATE

Code: 4550K0SC9B

Class Code: IACT

THIMEROSAL

Code: 2225PI3MOV

Class Code: IACT

POLYSORBATE 80

Code: 6OZP39ZG8H

Class Code: IACT

THONZONIUM BROMIDE

Quantity: 0.5 mg in 1 mL

Code: JI2B19CR0R

Class Code: ACTIB

NEOMYCIN SULFATE

Quantity: 3.3 mg in 1 mL

Code: 057Y626693

Class Code: ACTIM

COLISTIN SULFATE

Quantity: 3 mg in 1 mL

Code: WP15DXU577

Class Code: ACTIM

ACETIC ACID

Code: Q40Q9N063P

Class Code: IACT

HYDROCORTISONE ACETATE

Quantity: 10 mg in 1 mL

Code: 3X7931PO74

Class Code: ACTIB

Active Moieties

THONZONIUM

Code: Z05ZE98FV8

COLISTIN

Code: Z67X93HJG1

NEOMYCIN

Code: I16QD7X297

HYDROCORTISONE

Code: WI4X0X7BPJ

Basic Information

Regulatory Information

Company Information

Active Ingredients

SODIUM ACETATE

THIMEROSAL

POLYSORBATE 80

ACETIC ACID

Active Moieties

THONZONIUM

COLISTIN

NEOMYCIN

HYDROCORTISONE