Cortisporin TC
- Product NDC
- 63481-529
- 11-digit product format
- 634810529
- Labeler code
- 63481
- Product ID
- 63481-529_ec1e8a16-a5be-4ff7-a8fe-e0cbfd25aea6
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- colistin sulfate, neomycin sulfate, thonzonium bromide and hydrocortisone acetate
- Dosage form
- SUSPENSION
- Route
- AURICULAR (OTIC)
- Labeler
- Endo USA, Inc.
- Application
- NDA050356
- Marketing category
- NDA
- Marketing start
- 2019-06-03
- Substance
- COLISTIN SULFATE; HYDROCORTISONE ACETATE; NEOMYCIN SULFATE; THONZONIUM BROMIDE
- Active strength
- 3; 10; 3.3; .5 mg/mL; mg/mL; mg/mL; mg/mL
- Pharmacologic classes
- Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Cortisporin TC
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| COLISTIN SULFATE | 3 mg/mL |
| HYDROCORTISONE ACETATE | 10 mg/mL |
| NEOMYCIN SULFATE | 3.3 mg/mL |
| THONZONIUM BROMIDE | .5 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | WP15DXU577, 3X7931PO74, 057Y626693, JI2B19CR0R |
| Rxcui | 854992, 854997 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 63481-529-10 | Cortisporin TC | 10 mL in 1 BOTTLE, DROPPER | SUSPENSION | 10 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 63481-529 | CORTISPORIN TC (COLISTIN SULFATE, NEOMYCIN SULFATE, THONZONIUM BROMIDE AND HYDROCORTISONE ACETATE) SUSPENSION [ENDO USA, INC.] | 5 | Current NDC, Legacy NDC, 1 package rows | 20240913_9c6fc1c7-3350-42ae-b999-aca48e704bb1.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 63481-529-10 | 63481052910 | 10 mL in 1 BOTTLE, DROPPER (63481-529-10) | 10 ml | 2019-06-03 | 0000-00-00 | No | No | Current |