LOTEPREDNOL ETABONATE
- Product NDC
- 0574-4080
- 11-digit product format
- 005744080
- Labeler code
- 0574
- Product ID
- 0574-4080_08241818-e7df-4834-87c4-816c99d240de
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- loteprednol etabonate
- Dosage form
- SUSPENSION/ DROPS
- Route
- OPHTHALMIC
- Labeler
- Padagis US LLC
- Application
- ANDA215203
- Marketing category
- ANDA
- Marketing start
- 2026-03-31
- Substance
- LOTEPREDNOL ETABONATE
- Active strength
- 2 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
- LOTEPREDNOL ETABONATE
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| LOTEPREDNOL ETABONATE | 2 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | YEH1EZ96K6 |
| Rxcui | 311381 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0574-4080-05 | LOTEPREDNOL ETABONATE | 1 in 1 CARTON | SUSPENSION/ DROPS | 1 | | 2 |
| 0574-4080-05 | LOTEPREDNOL ETABONATE | 5 mL in 1 BOTTLE, DROPPER | SUSPENSION/ DROPS | 5 | | 2 |
| 0574-4080-10 | LOTEPREDNOL ETABONATE | 1 in 1 CARTON | SUSPENSION/ DROPS | 1 | | 2 |
| 0574-4080-10 | LOTEPREDNOL ETABONATE | 10 mL in 1 BOTTLE, DROPPER | SUSPENSION/ DROPS | 10 | | 2 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 0574-4080-05 | 00574408005 | 1 BOTTLE, DROPPER in 1 CARTON (0574-4080-05) / 5 mL in 1 BOTTLE, DROPPER | 2026-03-31 | No | No | Current |
| 0574-4080-10 | 00574408010 | 1 BOTTLE, DROPPER in 1 CARTON (0574-4080-10) / 10 mL in 1 BOTTLE, DROPPER | 2026-03-31 | No | No | Current |