FML is a Ophthalmic Suspension/ Drops in the Human Prescription Drug category. It is labeled and distributed by Allergan, Inc.. The primary component is Fluorometholone.
| Product ID | 11980-211_316943be-c8bc-4108-8e38-1d6bee153a42 |
| NDC | 11980-211 |
| Product Type | Human Prescription Drug |
| Proprietary Name | FML |
| Generic Name | Fluorometholone |
| Dosage Form | Suspension/ Drops |
| Route of Administration | OPHTHALMIC |
| Marketing Start Date | 1972-02-01 |
| Marketing Category | NDA / NDA |
| Application Number | NDA016851 |
| Labeler Name | Allergan, Inc. |
| Substance Name | FLUOROMETHOLONE |
| 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 |
| Marketing Start Date | 1972-02-01 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| Marketing Category | NDA |
| Application Number | NDA016851 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 1972-02-01 |
| Marketing End Date | 2013-02-14 |
| Marketing Category | NDA |
| Application Number | NDA016851 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 1972-02-01 |
| Marketing Category | NDA |
| Application Number | NDA016851 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 1972-02-01 |
| Ingredient | Strength |
|---|---|
| FLUOROMETHOLONE | 1 mg/mL |
| SPL SET ID: | c374d65a-35b5-4c9e-9069-5148875dc4df |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI |
| NDC | Brand Name | Generic Name |
|---|---|---|
| 0023-0316 | FML | fluorometholone |
| 11980-211 | FML | fluorometholone |
| 60758-880 | FLUOROMETHOLONE | fluorometholone |
| 70518-1929 | FLUOROMETHOLONE | fluorometholone |
| 11980-228 | FML FORTE | fluorometholone |