Prescription drug · NDA
Flarex (Fluorometholone acetate) NDC 71776-100
Fluorometholone acetate 1 mg/mL · Suspension/ drops · Ophthalmic · Eyevance Pharmaceuticals
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71776-100-03 | 7177601000371776010003 | 1 BOTTLE, PLASTIC in 1 CARTON (71776-100-03) / 2.5 mL in 1 BOTTLE, PLASTICMarketed from Jan 1, 2022 · Sample package | |
| 71776-100-05 | 7177601000571776010005 | 1 BOTTLE, PLASTIC in 1 CARTON (71776-100-05) / 5 mL in 1 BOTTLE, PLASTICMarketed from Mar 5, 2019 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Flarex
- Generic name (nonproprietary)
- fluorometholone acetate
- Active ingredients
- Fluorometholone acetate — 1 mg/mL
- Dosage form
- Suspension/ drops
- Route
- Ophthalmic
- Labeler
- Eyevance PharmaceuticalsNDC labeler code 71776
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 019079
- Marketing start
- Listing expires
- Other FDA classes
- Corticosteroid Hormone Receptor Agonists (Mechanism)
- Identifiers
- Product ID 71776-100_2bed0334-e39e-c18b-e063-6294a90af598SPL ID 2bed0334-e39e-c18b-e063-6294a90af598SPL set ID 19918ea5-8568-44d6-b8ee-7b2197cee85cRxCUI 1249629, 1249631UNII 9I50C3I3OKUPC 0371776100059, 0371776100035
- Pharmacologic class
- Corticosteroid
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Ophthalmic products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N471776010003followed by a unit qualifier and the quantityPackage 71776-0100-03. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
INDICATIONS AND USAGE FLAREX (fluorometholone acetate ophthalmic suspension) 0.1% is indicated for use in the treatment of steroid responsive inflammatory conditions of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the eye.
Excerpt only. Read the full label for complete information.
About NDC 71776-100
- What is NDC 71776-100?
- 71776-100 is the product NDC for Flarex (fluorometholone acetate), Fluorometholone acetate 1 mg/mL suspension/ drops, listed with the FDA by Eyevance Pharmaceuticals. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Flarex (Fluorometholone acetate).
- What is the active ingredient?
- Fluorometholone acetate.
- Who is the labeler?
- Eyevance Pharmaceuticals, NDC labeler code 71776. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Flarex?
- 1 other product NDC are listed under this name. See all Flarex NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Flarex products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Flarexfluorometholone acetate | Fluorometholone acetate 1 mg/mL | Suspension/ dropsOphthalmic | Harrow Eye, LLC | 82667-010 | 82667-0010-0082667-0010-01 |
Other NDCs under NDA 019079
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Flarexfluorometholone acetate | Fluorometholone acetate 1 mg/mL | Suspension/ dropsOphthalmic | Harrow Eye, LLC | 82667-010 |