FML FORTE
- Product NDC
- 11980-228
- 11-digit product format
- 119800228
- Labeler code
- 11980
- Product ID
- 11980-228_45789d76-a9c1-4ac5-84a1-fa2f9db729d9
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- fluorometholone
- Dosage form
- SUSPENSION/ DROPS
- Route
- OPHTHALMIC
- Labeler
- Allergan, Inc.
- Application
- NDA019216
- Marketing category
- NDA
- Marketing start
- 1986-05-01
- Substance
- FLUOROMETHOLONE
- Active strength
- 2.5 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
- FML FORTE
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| FLUOROMETHOLONE | 2.5 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | SV0CSG527L |
| Rxcui | 208420, 310376 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 11980-228-05 | FML FORTE | 5 mL in 1 BOTTLE, DROPPER | SUSPENSION/ DROPS | 5 | | 16 |
| 11980-228-05 | FML FORTE | 1 in 1 CARTON | SUSPENSION/ DROPS | 1 | | 16 |
| 11980-228-10 | FML FORTE | 1 in 1 CARTON | SUSPENSION/ DROPS | 1 | | 16 |
| 11980-228-10 | FML FORTE | 10 mL in 1 BOTTLE, DROPPER | SUSPENSION/ DROPS | 10 | | 16 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| fluorometholone | ACTIVE INGREDIENT | SV0CSG527L | FML FORTE (FLUOROMETHOLONE) SUSPENSION/ DROPS [ALLERGAN, INC.] | 4 | |
| fluorometholone | ACTIVE MOIETY | SV0CSG527L | FML FORTE (FLUOROMETHOLONE) SUSPENSION/ DROPS [ALLERGAN, INC.] | 4 | |
| benzalkonium chloride | INACTIVE INGREDIENT | F5UM2KM3W7 | FML FORTE (FLUOROMETHOLONE) SUSPENSION/ DROPS [ALLERGAN, INC.] | 4 | |
| edetate disodium | INACTIVE INGREDIENT | 7FLD91C86K | FML FORTE (FLUOROMETHOLONE) SUSPENSION/ DROPS [ALLERGAN, INC.] | 4 | |
| polysorbate 80 | INACTIVE INGREDIENT | 6OZP39ZG8H | FML FORTE (FLUOROMETHOLONE) SUSPENSION/ DROPS [ALLERGAN, INC.] | 4 | |
| polyvinyl alcohol | INACTIVE INGREDIENT | 532B59J990 | FML FORTE (FLUOROMETHOLONE) SUSPENSION/ DROPS [ALLERGAN, INC.] | 4 | |
| sodium chloride | INACTIVE INGREDIENT | 451W47IQ8X | FML FORTE (FLUOROMETHOLONE) SUSPENSION/ DROPS [ALLERGAN, INC.] | 4 | |
| sodium hydroxide | INACTIVE INGREDIENT | 55X04QC32I | FML FORTE (FLUOROMETHOLONE) SUSPENSION/ DROPS [ALLERGAN, INC.] | 4 | |
| sodium phosphate, dibasic | INACTIVE INGREDIENT | GR686LBA74 | FML FORTE (FLUOROMETHOLONE) SUSPENSION/ DROPS [ALLERGAN, INC.] | 4 | |
| sodium phosphate, monobasic | INACTIVE INGREDIENT | 3980JIH2SW | FML FORTE (FLUOROMETHOLONE) SUSPENSION/ DROPS [ALLERGAN, INC.] | 4 | |
| water | INACTIVE INGREDIENT | 059QF0KO0R | FML FORTE (FLUOROMETHOLONE) SUSPENSION/ DROPS [ALLERGAN, INC.] | 4 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 11980-228 | FML FORTE (FLUOROMETHOLONE) SUSPENSION/ DROPS [ALLERGAN, INC.] | 16 | Current NDC, Legacy NDC, 4 package rows | 20250223_b810b4c3-ac7a-4ba5-85bf-ebfaf3b1dabf.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 11980-228-05 | 11980022805 | 1 BOTTLE, DROPPER in 1 CARTON (11980-228-05) / 5 mL in 1 BOTTLE, DROPPER | 1986-05-01 | 0000-00-00 | No | No | Current |
| 11980-228-10 | 11980022810 | 1 BOTTLE, DROPPER in 1 CARTON (11980-228-10) / 10 mL in 1 BOTTLE, DROPPER | 1986-05-01 | 0000-00-00 | No | No | Current |