Flarex
- Product NDC
- 82667-010
- 11-digit product format
- 826670010
- Labeler code
- 82667
- Product ID
- 82667-010_31ac358e-0c93-1db8-e063-6294a90ae8e5
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- fluorometholone acetate
- Dosage form
- SUSPENSION/ DROPS
- Route
- OPHTHALMIC
- Labeler
- Harrow Eye, LLC
- Application
- NDA019079
- Marketing category
- NDA
- Marketing start
- 2025-03-31
- Substance
- FLUOROMETHOLONE ACETATE
- Active strength
- 1 mg/mL
- Pharmacologic classes
- Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Flarex
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| FLUOROMETHOLONE ACETATE | 1 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 9I50C3I3OK |
| Rxcui | 1249629, 1249631 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 82667-010-00 | Flarex | 2.5 mL in 1 BOTTLE, PLASTIC | SUSPENSION/ DROPS | 2.5 | | 2 |
| 82667-010-00 | Flarex | 1 in 1 CARTON | SUSPENSION/ DROPS | 1 | | 2 |
| 82667-010-01 | Flarex | 1 in 1 CARTON | SUSPENSION/ DROPS | 1 | | 2 |
| 82667-010-01 | Flarex | 5 mL in 1 BOTTLE, PLASTIC | SUSPENSION/ DROPS | 5 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 82667-010 | FLAREX (FLUOROMETHOLONE ACETATE) SUSPENSION/ DROPS [HARROW EYE, LLC] | 2 | Current NDC, 4 package rows | 20250403_f060dec4-09dc-4266-ab4c-a6ed49cd8126.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 82667-010-00 | 82667001000 | 1 BOTTLE, PLASTIC in 1 CARTON (82667-010-00) / 2.5 mL in 1 BOTTLE, PLASTIC | 2025-03-31 | Yes | No | Historical |
| 82667-010-01 | 82667001001 | 1 BOTTLE, PLASTIC in 1 CARTON (82667-010-01) / 5 mL in 1 BOTTLE, PLASTIC | 2025-03-31 | No | No | Historical |