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NDC 71776-0100-03 Flarex 1 mg/mL Details
Flarex 1 mg/mL
Flarex is a OPHTHALMIC SUSPENSION/ DROPS in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Eyevance Pharmaceuticals. The primary component is FLUOROMETHOLONE ACETATE.
Product Information
| NDC | 71776-0100 |
|---|---|
| Product ID | 71776-100_0760a31d-934e-56a0-e063-6294a90acb70 |
| Associated GPIs | 86300020101810 |
| GCN Sequence Number | 016760 |
| GCN Sequence Number Description | fluorometholone acetate DROPS SUSP 0.1 % OPHTHALMIC |
| HIC3 | Q6P |
| HIC3 Description | EYE ANTI-INFLAMMATORY AGENTS |
| GCN | 32861 |
| HICL Sequence Number | 006390 |
| HICL Sequence Number Description | FLUOROMETHOLONE ACETATE |
| Brand/Generic | Brand |
| Proprietary Name | Flarex |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | fluorometholone acetate |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | SUSPENSION/ DROPS |
| Route | OPHTHALMIC |
| Active Ingredient Strength | 1 |
| Active Ingredient Units | mg/mL |
| Substance Name | FLUOROMETHOLONE ACETATE |
| Labeler Name | Eyevance Pharmaceuticals |
| Pharmaceutical Class | Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC] |
| DEA Schedule | n/a |
| Marketing Category | NDA |
| Application Number | NDA019079 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 71776-0100-03 (71776010003)
| NDC Package Code | 71776-100-03 |
|---|---|
| Billing NDC | 71776010003 |
| Package | 1 BOTTLE, PLASTIC in 1 CARTON (71776-100-03) / 2.5 mL in 1 BOTTLE, PLASTIC |
| Marketing Start Date | 2022-01-01 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |