NDC 63481-529
Cortisporin TC
Colistin Sulfate, Neomycin Sulfate, Thonzonium Bromide And Hydrocortisone Acetate
Cortisporin TC is a Auricular (otic) Suspension in the Human Prescription Drug category. It is labeled and distributed by Endo Pharmaceuticals, Inc.. The primary component is Colistin Sulfate; Neomycin Sulfate; Thonzonium Bromide; Hydrocortisone Acetate.
| Product ID | 63481-529_7d79882e-12eb-4b51-88f8-6d0089fa5122 |
| NDC | 63481-529 |
| Product Type | Human Prescription Drug |
| Proprietary Name | Cortisporin TC |
| Generic Name | Colistin Sulfate, Neomycin Sulfate, Thonzonium Bromide And Hydrocortisone Acetate |
| Dosage Form | Suspension |
| Route of Administration | AURICULAR (OTIC) |
| Marketing Start Date | 2019-06-03 |
| Marketing Category | NDA / NDA |
| Application Number | NDA050356 |
| Labeler Name | Endo Pharmaceuticals, Inc. |
| Substance Name | COLISTIN SULFATE; NEOMYCIN SULFATE; THONZONIUM BROMIDE; HYDROCORTISONE ACETATE |
| Active Ingredient Strength | 3 mg/mL; mg/mL; mg/mL; mg/mL |
| Pharm Classes | Aminoglycoside Antibacterial [EPC],Aminoglycosides [CS],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2020-12-31 |
Packaging
NDC 63481-529-10
10 mL in 1 BOTTLE, DROPPER (63481-529-10)
| Marketing Start Date | 2019-06-03 |
| NDC Exclude Flag | N |
| Sample Package? | N |
NDC SPL Data Element Entries
NDC 63481-529-10 [63481052910]
Cortisporin TC SUSPENSION
| Marketing Category | NDA |
| Application Number | NDA050356 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2019-06-03 |
Drug Details
Active Ingredients
| Ingredient | Strength |
|---|---|
| COLISTIN SULFATE | 3 mg/mL |
Pharmacological Class
- Aminoglycoside Antibacterial [EPC]
- Aminoglycosides [CS]
- Corticosteroid [EPC]
- Corticosteroid Hormone Receptor Agonists [MoA]
- Aminoglycoside Antibacterial [EPC]
- Aminoglycosides [CS]
- Corticosteroid [EPC]
- Corticosteroid Hormone Receptor Agonists [MoA]
NDC Crossover Matching brand name "Cortisporin TC" or generic name "Colistin Sulfate, Neomycin Sulfate, Thonzonium Bromide And Hydrocortisone Acetate"
| NDC | Brand Name | Generic Name |
|---|---|---|
| 63481-529 | Cortisporin TC | colistin sulfate, neomycin sulfate, thonzonium bromide and hydrocortisone acetate |
| 63481-421 | Coly-Mycin S | colistin sulfate, neomycin sulfate, thonzonium bromide and hydrocortisone acetate |
Trademark Results [Cortisporin TC]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 CORTISPORIN TC 75527292 2365721 Dead/Cancelled |
MONARCH PHARMACEUTICALS 1998-07-29 |
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