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NDC 60219-1585-03 fluorometholone ophthalmic suspension 1 mg/mL Details
fluorometholone ophthalmic suspension 1 mg/mL
fluorometholone ophthalmic suspension is a OPHTHALMIC SUSPENSION/ DROPS in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Amneal Pharmaceuticals NY LLC. The primary component is FLUOROMETHOLONE.
Product Information
| NDC | 60219-1585 |
|---|---|
| Product ID | 60219-1585_6cb30deb-0a3d-4686-bcab-3f7cfbe5ac23 |
| Associated GPIs | |
| GCN Sequence Number | 007902 |
| GCN Sequence Number Description | fluorometholone DROPS SUSP 0.1 % OPHTHALMIC |
| HIC3 | Q6P |
| HIC3 Description | EYE ANTI-INFLAMMATORY AGENTS |
| GCN | 33250 |
| HICL Sequence Number | 003316 |
| HICL Sequence Number Description | FLUOROMETHOLONE |
| Brand/Generic | Generic |
| Proprietary Name | fluorometholone ophthalmic suspension |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | fluorometholone |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | SUSPENSION/ DROPS |
| Route | OPHTHALMIC |
| Active Ingredient Strength | 1 |
| Active Ingredient Units | mg/mL |
| Substance Name | FLUOROMETHOLONE |
| Labeler Name | Amneal Pharmaceuticals NY LLC |
| Pharmaceutical Class | Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA216348 |
| Listing Certified Through | 2025-12-31 |
Package
NDC 60219-1585-03 (60219158503)
| NDC Package Code | 60219-1585-3 |
|---|---|
| Billing NDC | 60219158503 |
| Package | 1 BOTTLE, DROPPER in 1 CARTON (60219-1585-3) / 5 mL in 1 BOTTLE, DROPPER |
| Marketing Start Date | 2023-01-09 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |