Zylet
- Product NDC
- 24208-358
- 11-digit product format
- 242080358
- Labeler code
- 24208
- Product ID
- 24208-358_4e532599-a607-4047-a600-d3e32fd515a4
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- loteprednol etabonate and tobramycin
- Dosage form
- SUSPENSION/ DROPS
- Route
- OPHTHALMIC
- Labeler
- Bausch & Lomb Incorporated
- Application
- NDA050804
- Marketing category
- NDA
- Marketing start
- 2004-12-14
- Substance
- LOTEPREDNOL ETABONATE; TOBRAMYCIN
- Active strength
- 5; 3 mg/mL; mg/mL
- Pharmacologic classes
- Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], 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
- Zylet
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| LOTEPREDNOL ETABONATE | 5 mg/mL |
| TOBRAMYCIN | 3 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | YEH1EZ96K6, VZ8RRZ51VK |
| Rxcui | 545255, 545259 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 24208-358-01 | Zylet | 1 in 1 CARTON | SUSPENSION/ DROPS | 1 | | 18 |
| 24208-358-01 | Zylet | 1 mL in 1 BOTTLE, DROPPER | SUSPENSION/ DROPS | 1 | | 18 |
| 24208-358-05 | Zylet | 5 mL in 1 BOTTLE, DROPPER | SUSPENSION/ DROPS | 5 | | 18 |
| 24208-358-05 | Zylet | 1 in 1 CARTON | SUSPENSION/ DROPS | 1 | | 18 |
| 24208-358-10 | Zylet | 10 mL in 1 BOTTLE, DROPPER | SUSPENSION/ DROPS | 10 | | 18 |
| 24208-358-10 | Zylet | 1 in 1 CARTON | SUSPENSION/ DROPS | 1 | | 18 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 24208-358 | ZYLET (LOTEPREDNOL ETABONATE AND TOBRAMYCIN) SUSPENSION/ DROPS [BAUSCH & LOMB INCORPORATED] | 18 | Current NDC, Legacy NDC, 6 package rows | 20220914_3dd9b060-5355-404d-bdf1-09ee8b52a9f5.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 24208-358-01 | 24208035801 | 1 BOTTLE, DROPPER in 1 CARTON (24208-358-01) / 1 mL in 1 BOTTLE, DROPPER | 2004-12-14 | 0000-00-00 | Yes | No | Current |
| 24208-358-05 | 24208035805 | 1 BOTTLE, DROPPER in 1 CARTON (24208-358-05) / 5 mL in 1 BOTTLE, DROPPER | 2004-12-14 | 0000-00-00 | No | No | Current |
| 24208-358-10 | 24208035810 | 1 BOTTLE, DROPPER in 1 CARTON (24208-358-10) / 10 mL in 1 BOTTLE, DROPPER | 2004-12-14 | 0000-00-00 | No | No | Current |