NDC 0065-0345
ALOMIDE
Lodoxamide Tromethamine
ALOMIDE is a Ophthalmic Solution/ Drops in the Human Prescription Drug category. It is labeled and distributed by Alcon Laboratories, Inc.. The primary component is Lodoxamide Tromethamine.
| Product ID | 0065-0345_03d9a61d-ef23-486d-a798-2e604f84d2f3 |
| NDC | 0065-0345 |
| Product Type | Human Prescription Drug |
| Proprietary Name | ALOMIDE |
| Generic Name | Lodoxamide Tromethamine |
| Dosage Form | Solution/ Drops |
| Route of Administration | OPHTHALMIC |
| Marketing Start Date | 1993-09-30 |
| Marketing Category | NDA / NDA |
| Application Number | NDA020191 |
| Labeler Name | Alcon Laboratories, Inc. |
| Substance Name | LODOXAMIDE TROMETHAMINE |
| Active Ingredient Strength | 1 mg/mL |
| Pharm Classes | Decreased Histamine Release [PE], Mast Cell Stabilizer [EPC] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2023-12-31 |
Packaging
NDC 0065-0345-10
1 BOTTLE, PLASTIC in 1 CARTON (0065-0345-10) > 10 mL in 1 BOTTLE, PLASTIC
| Marketing Start Date | 1993-09-30 |
| NDC Exclude Flag | N |
| Sample Package? | N |
NDC SPL Data Element Entries
NDC 0065-0345-25 [00065034525]
ALOMIDE SOLUTION/ DROPS
| Marketing Category | NDA |
| Application Number | NDA020191 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 1993-09-30 |
| Marketing End Date | 2011-07-29 |
NDC 0065-0345-10 [00065034510]
ALOMIDE SOLUTION/ DROPS
| Marketing Category | NDA |
| Application Number | NDA020191 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 1993-09-30 |
Drug Details
Active Ingredients
| Ingredient | Strength |
|---|---|
| LODOXAMIDE TROMETHAMINE | 1 mg/mL |
OpenFDA Data
| SPL SET ID: | 1b97597f-f2e7-4574-81a8-f35b769c957a |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI |
Pharmacological Class
- Decreased Histamine Release [PE]
- Mast Cell Stabilizer [EPC]
NDC Crossover Matching brand name "ALOMIDE" or generic name "Lodoxamide Tromethamine"
| NDC | Brand Name | Generic Name |
|---|---|---|
| 0065-0345 | ALOMIDE | lodoxamide tromethamine |
| 0078-0736 | ALOMIDE | lodoxamide tromethamine |
Trademark Results [ALOMIDE]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ALOMIDE 73721899 1509914 Live/Registered |
ALCON LABORATORIES, INC. 1988-04-11 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.