Loteprednol Etabonate
- Product NDC
- 70244-036
- 11-digit product format
- 702440036
- Labeler code
- 70244
- Product ID
- 70244-036_4f81be91-92e8-1205-e063-6394a90a6e82
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Loteprednol Etabonate
- Dosage form
- GEL
- Route
- OPHTHALMIC
- Labeler
- Sentiss Pharmaceuticals LLC
- Application
- ANDA212080
- Marketing category
- ANDA
- Marketing start
- 2026-04-17
- Substance
- LOTEPREDNOL ETABONATE
- Active strength
- 5 mg/g
- 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 | 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 |
|---|
| 70244-036-01 | Loteprednol Etabonate | 1 in 1 CARTON | GEL | 1 | | 2 |
| 70244-036-01 | Loteprednol Etabonate | 5 g in 1 BOTTLE, DROPPER | GEL | 5 | | 2 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 70244-036-01 | 70244003601 | 1 BOTTLE, DROPPER in 1 CARTON (70244-036-01) / 5 g in 1 BOTTLE, DROPPER | 2026-04-17 | No | No | Historical |