Back to search
🇺🇸

United States · US · US:24208-358_4e532599-a607-4047-a600-d3e32fd515a4

Zylet

Orange BookUNIIATC J01GB

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerBausch & Lomb Incorporated
CountryUS (United States)
ATC codeJ01GB
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 3

  • ndc11
    2420835801
    1 BOTTLE, DROPPER in 1 CARTON (24208-358-01) / 1 mL in 1 BOTTLE, DROPPER
  • ndc11
    2420835805
    1 BOTTLE, DROPPER in 1 CARTON (24208-358-05) / 5 mL in 1 BOTTLE, DROPPER
  • ndc11
    2420835810
    1 BOTTLE, DROPPER in 1 CARTON (24208-358-10) / 10 mL in 1 BOTTLE, DROPPER

Annotations

UNII (FDA Substance ID)
YEH1EZ96K6
LOTEPREDNOL ETABONATE
RxCUI 52177
Orange Book
N050804
AB
Raw payload (JSON)
{
  "unii": {
    "unii": "YEH1EZ96K6",
    "rxcui": "52177",
    "inchikey": "DMKSVUSAATWOCU-HROMYWEYSA-N",
    "display_name": "LOTEPREDNOL ETABONATE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "OPHTHALMIC",
  "productid": "24208-358_4e532599-a607-4047-a600-d3e32fd515a4",
  "productndc": "24208-358",
  "dosage_form": "SUSPENSION/ DROPS",
  "orange_book": {
    "appl_no": "050804",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "0.5%;0.3%",
        "product_no": "001",
        "approval_date": "Dec 14, 2004"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "LOTEPREDNOL ETABONATE; TOBRAMYCIN",
  "proprietary_name": "Zylet",
  "active_ingred_unit": "mg/mL; mg/mL",
  "application_number": "NDA050804",
  "marketing_category": "NDA",
  "nonproprietary_name": "loteprednol etabonate and tobramycin",
  "start_marketing_date": "20041214",
  "active_numerator_strength": "5; 3"
}

Related drugs

Other records sharing ATC code J01GB.

Access this data programmatically

Query Zylet and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.