Loteprednol Etabonate
- Product NDC
- 68682-299
- 11-digit product format
- 686820299
- Labeler code
- 68682
- Product ID
- 68682-299_4fae2525-e16d-8c0f-e063-6294a90a143b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- loteprednol etabonate
- Dosage form
- SUSPENSION/ DROPS
- Route
- OPHTHALMIC
- Labeler
- Oceanside Pharmaceuticals
- Application
- NDA020583
- Marketing category
- NDA AUTHORIZED GENERIC
- Marketing start
- 2019-07-01
- Marketing end
- 2026-05-31
- Substance
- LOTEPREDNOL ETABONATE
- Active strength
- 5 mg/mL
- Pharmacologic classes
- Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
- NDC exclude flag
- No
- Current FDA listing
- Yes
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68682-299-05 | Loteprednol Etabonate | 1 in 1 CARTON | SUSPENSION/ DROPS | 1 | | 3 |
| 68682-299-05 | Loteprednol Etabonate | 5 mL in 1 BOTTLE | SUSPENSION/ DROPS | 5 | | 3 |
| 68682-299-10 | Loteprednol Etabonate | 1 in 1 CARTON | SUSPENSION/ DROPS | 1 | | 3 |
| 68682-299-10 | Loteprednol Etabonate | 10 mL in 1 BOTTLE | SUSPENSION/ DROPS | 10 | | 3 |
| 68682-299-15 | Loteprednol Etabonate | 1 in 1 CARTON | SUSPENSION/ DROPS | 1 | | 3 |
| 68682-299-15 | Loteprednol Etabonate | 15 mL in 1 BOTTLE | SUSPENSION/ DROPS | 15 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68682-299 | LOTEPREDNOL ETABONATE SUSPENSION/ DROPS [OCEANSIDE PHARMACEUTICALS] | 2 | Current NDC, Legacy NDC, 6 package rows | 20200825_f9edfd73-e1b1-44e4-8e7c-90b0c2fa204d.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 68682-299-05 | 68682029905 | 1 BOTTLE in 1 CARTON (68682-299-05) > 5 mL in 1 BOTTLE | 1 bottle | 2019-07-01 | 0000-00-00 | No | No | Current |
| 68682-299-10 | 68682029910 | 1 BOTTLE in 1 CARTON (68682-299-10) / 10 mL in 1 BOTTLE | 1 bottle | 2019-07-01 | 2026-05-31 | No | No | Current |
| 68682-299-15 | 68682029915 | 1 BOTTLE in 1 CARTON (68682-299-15) > 15 mL in 1 BOTTLE | 1 bottle | 2019-07-01 | 0000-00-00 | No | No | Current |