FML
- Product NDC
- 0781-6187
- 11-digit product format
- 007816187
- Labeler code
- 0781
- Product ID
- 0781-6187_4d324ee9-c00e-27ba-e063-6294a90a049c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- fluorometholone
- Dosage form
- SUSPENSION/ DROPS
- Route
- OPHTHALMIC
- Labeler
- Sandoz Inc
- Application
- ANDA218819
- Marketing category
- ANDA
- Marketing start
- 2026-03-30
- Substance
- FLUOROMETHOLONE
- Active strength
- 1 mg/mL
- Pharmacologic classes
- Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- FML
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| FLUOROMETHOLONE | 1 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | SV0CSG527L |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0781-6187-70 | FML | 1 in 1 CARTON | SUSPENSION/ DROPS | 1 | | 1 |
| 0781-6187-70 | FML | 10 mL in 1 BOTTLE, DROPPER | SUSPENSION/ DROPS | 10 | | 1 |
| 0781-6187-75 | FML | 1 in 1 CARTON | SUSPENSION/ DROPS | 1 | | 1 |
| 0781-6187-75 | FML | 5 mL in 1 BOTTLE, DROPPER | SUSPENSION/ DROPS | 5 | | 1 |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 0781-6187-70 | 00781618770 | 1 BOTTLE, DROPPER in 1 CARTON (0781-6187-70) / 10 mL in 1 BOTTLE, DROPPER | 2026-03-30 | No | No | Historical |
| 0781-6187-75 | 00781618775 | 1 BOTTLE, DROPPER in 1 CARTON (0781-6187-75) / 5 mL in 1 BOTTLE, DROPPER | 2026-03-30 | No | No | Historical |