FLUOROMETHOLONE is a Ophthalmic Solution/ Drops in the Human Prescription Drug category. It is labeled and distributed by Pacific Pharma, Inc.. The primary component is Fluorometholone.
| Product ID | 60758-880_0e22b3f0-1247-426a-b778-a7a680bbeab5 |
| NDC | 60758-880 |
| Product Type | Human Prescription Drug |
| Proprietary Name | FLUOROMETHOLONE |
| Generic Name | Fluorometholone |
| Dosage Form | Solution/ Drops |
| Route of Administration | OPHTHALMIC |
| Marketing Start Date | 1997-10-31 |
| Marketing Category | NDA AUTHORIZED GENERIC / NDA AUTHORIZED GENERIC |
| Application Number | NDA016851 |
| Labeler Name | Pacific Pharma, Inc. |
| Substance Name | FLUOROMETHOLONE |
| Active Ingredient Strength | 1 mg/mL |
| Pharm Classes | Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2023-12-31 |
| Marketing Start Date | 1997-10-31 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| Marketing Category | NDA AUTHORIZED GENERIC |
| Application Number | NDA016851 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 1997-10-31 |
| Marketing Category | NDA AUTHORIZED GENERIC |
| Application Number | NDA016851 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 1997-10-31 |
| Marketing Category | NDA AUTHORIZED GENERIC |
| Application Number | NDA016851 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 1997-10-31 |
| Marketing End Date | 2019-09-30 |
| Ingredient | Strength |
|---|---|
| FLUOROMETHOLONE | 1 mg/mL |
| SPL SET ID: | af59c420-789d-4c05-b3fc-c3f855bcac24 |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI | |
| UPC Code |
| NDC | Brand Name | Generic Name |
|---|---|---|
| 60758-880 | FLUOROMETHOLONE | fluorometholone |
| 70518-1929 | FLUOROMETHOLONE | fluorometholone |
| 0023-0316 | FML | fluorometholone |
| 11980-211 | FML | fluorometholone |
| 11980-228 | FML FORTE | fluorometholone |