zylet

Generic: loteprednol etabonate and tobramycin

Labeler: bausch & lomb incorporated
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name zylet
Generic Name loteprednol etabonate and tobramycin
Labeler bausch & lomb incorporated
Dosage Form SUSPENSION/ DROPS
Routes
OPHTHALMIC
Active Ingredients

loteprednol etabonate 5 mg/mL, tobramycin 3 mg/mL

Manufacturer
Bausch & Lomb Incorporated

Identifiers & Regulatory

Product NDC 24208-358
Product ID 24208-358_4e532599-a607-4047-a600-d3e32fd515a4
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA050804
Listing Expiration 2026-12-31
Marketing Start 2004-12-14

Pharmacologic Class

Established (EPC)
aminoglycoside antibacterial [epc]
Chemical Structure
aminoglycosides [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 24208358
Hyphenated Format 24208-358

Supplemental Identifiers

RxCUI
545255 545259
UNII
YEH1EZ96K6 VZ8RRZ51VK
NUI
N0000175477 M0000946

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name zylet (source: ndc)
Generic Name loteprednol etabonate and tobramycin (source: ndc)
Application Number NDA050804 (source: ndc)
Routes
OPHTHALMIC
source: ndc

Resolved Composition

Strengths
  • 5 mg/mL
  • 3 mg/mL
source: ndc
Packaging
  • 1 BOTTLE, DROPPER in 1 CARTON (24208-358-01) / 1 mL in 1 BOTTLE, DROPPER
  • 1 BOTTLE, DROPPER in 1 CARTON (24208-358-05) / 5 mL in 1 BOTTLE, DROPPER
  • 1 BOTTLE, DROPPER in 1 CARTON (24208-358-10) / 10 mL in 1 BOTTLE, DROPPER
source: ndc

Packages (3)

24208-358-01 1 BOTTLE, DROPPER in 1 CARTON (24208-358-01) / 1 mL in 1 BOTTLE, DROPPER 24208-358-05 1 BOTTLE, DROPPER in 1 CARTON (24208-358-05) / 5 mL in 1 BOTTLE, DROPPER 24208-358-10 1 BOTTLE, DROPPER in 1 CARTON (24208-358-10) / 10 mL in 1 BOTTLE, DROPPER

Ingredients (2)

loteprednol etabonate (5 mg/mL) tobramycin (3 mg/mL)

Linked Drug Pages (1)

Zylet ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["OPHTHALMIC"], "spl_id": "4e532599-a607-4047-a600-d3e32fd515a4", "openfda": {"nui": ["N0000175477", "M0000946"], "unii": ["YEH1EZ96K6", "VZ8RRZ51VK"], "rxcui": ["545255", "545259"], "spl_set_id": ["3dd9b060-5355-404d-bdf1-09ee8b52a9f5"], "pharm_class_cs": ["Aminoglycosides [CS]"], "pharm_class_epc": ["Aminoglycoside Antibacterial [EPC]"], "manufacturer_name": ["Bausch & Lomb Incorporated"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": true, "description": "1 BOTTLE, DROPPER in 1 CARTON (24208-358-01)  / 1 mL in 1 BOTTLE, DROPPER", "package_ndc": "24208-358-01", "marketing_start_date": "20041214"}, {"sample": false, "description": "1 BOTTLE, DROPPER in 1 CARTON (24208-358-05)  / 5 mL in 1 BOTTLE, DROPPER", "package_ndc": "24208-358-05", "marketing_start_date": "20041214"}, {"sample": false, "description": "1 BOTTLE, DROPPER in 1 CARTON (24208-358-10)  / 10 mL in 1 BOTTLE, DROPPER", "package_ndc": "24208-358-10", "marketing_start_date": "20041214"}], "brand_name": "Zylet", "product_id": "24208-358_4e532599-a607-4047-a600-d3e32fd515a4", "dosage_form": "SUSPENSION/ DROPS", "pharm_class": ["Aminoglycoside Antibacterial [EPC]", "Aminoglycosides [CS]", "Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "24208-358", "generic_name": "loteprednol etabonate and tobramycin", "labeler_name": "Bausch & Lomb Incorporated", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Zylet", "active_ingredients": [{"name": "LOTEPREDNOL ETABONATE", "strength": "5 mg/mL"}, {"name": "TOBRAMYCIN", "strength": "3 mg/mL"}], "application_number": "NDA050804", "marketing_category": "NDA", "marketing_start_date": "20041214", "listing_expiration_date": "20261231"}