Loteprednol Etabonate
- Product NDC
- 82260-508
- 11-digit product format
- 822600508
- Labeler code
- 82260
- Product ID
- 82260-508_2d5813e8-a1fc-db90-e063-6294a90a6ca7
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- loteprednol etabonate
- Dosage form
- GEL
- Route
- OPHTHALMIC
- Labeler
- Bausch & Lomb Americas Inc.
- Application
- NDA202872
- Marketing category
- NDA AUTHORIZED GENERIC
- Marketing start
- 2023-06-30
- Substance
- LOTEPREDNOL ETABONATE
- Active strength
- 5 mg/g
- 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
- Loteprednol Etabonate
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| LOTEPREDNOL ETABONATE | 5 mg/g |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | YEH1EZ96K6 |
| Rxcui | 1312625 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 82260-508-01 | Loteprednol Etabonate | 1 in 1 CARTON | GEL | 1 | | 5 |
| 82260-508-01 | Loteprednol Etabonate | 5 g in 1 BOTTLE | GEL | 5 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 82260-508 | LOTEPREDNOL ETABONATE GEL [BAUSCH & LOMB AMERICAS INC.] | 5 | Current NDC, 2 package rows | 20250206_cc8638ae-0444-4a8b-bcad-fa946f607b5d.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 82260-508-01 | 82260050801 | 1 BOTTLE in 1 CARTON (82260-508-01) / 5 g in 1 BOTTLE | 1 bottle | 2023-06-30 | No | No | Current |