FML
- Product NDC
- 11980-211
- 11-digit product format
- 119800211
- Labeler code
- 11980
- Product ID
- 11980-211_000b0dad-a290-4a62-81ec-208e0a9c058b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- fluorometholone
- Dosage form
- SUSPENSION/ DROPS
- Route
- OPHTHALMIC
- Labeler
- Allergan, Inc.
- Application
- NDA016851
- Marketing category
- NDA
- Marketing start
- 1972-02-01
- Substance
- FLUOROMETHOLONE
- 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
- FML
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| FLUOROMETHOLONE | 1 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | SV0CSG527L |
| Rxcui | 310377, 545243 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 11980-211-05 | FML | 1 in 1 CARTON | SUSPENSION/ DROPS | 1 | | 14 |
| 11980-211-05 | FML | 5 mL in 1 BOTTLE, DROPPER | SUSPENSION/ DROPS | 5 | | 14 |
| 11980-211-10 | FML | 1 in 1 CARTON | SUSPENSION/ DROPS | 1 | | 14 |
| 11980-211-10 | FML | 10 mL in 1 BOTTLE, DROPPER | SUSPENSION/ DROPS | 10 | | 14 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| fluorometholone | ACTIVE INGREDIENT | SV0CSG527L | FML (FLUOROMETHOLONE) SUSPENSION/ DROPS [ALLERGAN, INC.] | 5 | |
| fluorometholone | ACTIVE MOIETY | SV0CSG527L | FML (FLUOROMETHOLONE) SUSPENSION/ DROPS [ALLERGAN, INC.] | 5 | |
| benzalkonium chloride | INACTIVE INGREDIENT | F5UM2KM3W7 | FML (FLUOROMETHOLONE) SUSPENSION/ DROPS [ALLERGAN, INC.] | 5 | |
| edetate disodium | INACTIVE INGREDIENT | 7FLD91C86K | FML (FLUOROMETHOLONE) SUSPENSION/ DROPS [ALLERGAN, INC.] | 5 | |
| polysorbate 80 | INACTIVE INGREDIENT | 6OZP39ZG8H | FML (FLUOROMETHOLONE) SUSPENSION/ DROPS [ALLERGAN, INC.] | 5 | |
| polyvinyl alcohol | INACTIVE INGREDIENT | 532B59J990 | FML (FLUOROMETHOLONE) SUSPENSION/ DROPS [ALLERGAN, INC.] | 5 | |
| sodium chloride | INACTIVE INGREDIENT | 451W47IQ8X | FML (FLUOROMETHOLONE) SUSPENSION/ DROPS [ALLERGAN, INC.] | 5 | |
| sodium hydroxide | INACTIVE INGREDIENT | 55X04QC32I | FML (FLUOROMETHOLONE) SUSPENSION/ DROPS [ALLERGAN, INC.] | 5 | |
| sodium phosphate, dibasic | INACTIVE INGREDIENT | GR686LBA74 | FML (FLUOROMETHOLONE) SUSPENSION/ DROPS [ALLERGAN, INC.] | 5 | |
| sodium phosphate, monobasic | INACTIVE INGREDIENT | 3980JIH2SW | FML (FLUOROMETHOLONE) SUSPENSION/ DROPS [ALLERGAN, INC.] | 5 | |
| water | INACTIVE INGREDIENT | 059QF0KO0R | FML (FLUOROMETHOLONE) SUSPENSION/ DROPS [ALLERGAN, INC.] | 5 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 11980-211 | FML (FLUOROMETHOLONE) SUSPENSION/ DROPS [ALLERGAN, INC.] | 13 | Current NDC, Legacy NDC, 4 package rows | 20241108_c374d65a-35b5-4c9e-9069-5148875dc4df.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 |
|---|
| 11980-211-05 | 11980021105 | 1 BOTTLE, DROPPER in 1 CARTON (11980-211-05) / 5 mL in 1 BOTTLE, DROPPER | 1972-02-01 | 0000-00-00 | No | No | Current |
| 11980-211-10 | 11980021110 | 1 BOTTLE, DROPPER in 1 CARTON (11980-211-10) / 10 mL in 1 BOTTLE, DROPPER | 1972-02-01 | 0000-00-00 | No | No | Current |