NDC 0065-0096
Flarex
Fluorometholone Acetate
Flarex is a Ophthalmic Suspension/ Drops in the Human Prescription Drug category. It is labeled and distributed by Alcon Laboratories, Inc.. The primary component is Fluorometholone Acetate.
| Product ID | 0065-0096_a8be38a7-2eb3-4b53-86ec-7ccc69d19f10 |
| NDC | 0065-0096 |
| Product Type | Human Prescription Drug |
| Proprietary Name | Flarex |
| Generic Name | Fluorometholone Acetate |
| Dosage Form | Suspension/ Drops |
| Route of Administration | OPHTHALMIC |
| Marketing Start Date | 1992-02-06 |
| Marketing Category | NDA / NDA |
| Application Number | NDA019079 |
| Labeler Name | Alcon Laboratories, Inc. |
| Substance Name | FLUOROMETHOLONE ACETATE |
| Active Ingredient Strength | 1 mg/mL |
| Pharm Classes | Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2020-12-31 |
Packaging
NDC 0065-0096-05
1 BOTTLE, PLASTIC in 1 CARTON (0065-0096-05) > 5 mL in 1 BOTTLE, PLASTIC
| Marketing Start Date | 1992-02-06 |
| NDC Exclude Flag | N |
| Sample Package? | N |
NDC SPL Data Element Entries
NDC 0065-0096-10 [00065009610]
Flarex SUSPENSION/ DROPS
| Marketing Category | NDA |
| Application Number | NDA019079 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 1992-02-06 |
| Marketing End Date | 2011-08-01 |
NDC 0065-0096-04 [00065009604]
Flarex SUSPENSION/ DROPS
| Marketing Category | NDA |
| Application Number | NDA019079 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 1992-02-06 |
| Marketing End Date | 2011-08-01 |
NDC 0065-0096-25 [00065009625]
Flarex SUSPENSION/ DROPS
| Marketing Category | NDA |
| Application Number | NDA019079 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 1992-02-06 |
| Marketing End Date | 2011-08-01 |
NDC 0065-0096-05 [00065009605]
Flarex SUSPENSION/ DROPS
| Marketing Category | NDA |
| Application Number | NDA019079 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 1992-02-06 |
Drug Details
Active Ingredients
| Ingredient | Strength |
|---|---|
| FLUOROMETHOLONE ACETATE | 1 mg/mL |
OpenFDA Data
| SPL SET ID: | 6ae122c0-eb4f-4124-96d7-ba5e9a350d35 |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI |
Pharmacological Class
- Corticosteroid [EPC]
- Corticosteroid Hormone Receptor Agonists [MoA]
NDC Crossover Matching brand name "Flarex" or generic name "Fluorometholone Acetate"
| NDC | Brand Name | Generic Name |
|---|---|---|
| 0065-0096 | Flarex | fluorometholone acetate |
| 71776-100 | Flarex | fluorometholone acetate |
Trademark Results [Flarex]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 FLAREX 74340342 1786390 Dead/Cancelled |
Environmental Science International, Incorporated 1992-12-15 |
 FLAREX 73617344 1437695 Live/Registered |
ALCON LABORATORIES, INC. 1986-08-29 |
 FLAREX 72313796 0897175 Dead/Expired |
AIROIL BURNER COMPANY 1968-12-06 |
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