Back to search
🇺🇸

United States · US · US:82667-011_31ba978f-7bc8-031f-e063-6394a90ae09c

Tobradex ST

Orange BookUNIISPLATC A01AC

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

Identification

ManufacturerHarrow Eye, LLC
CountryUS (United States)
ATC codeA01AC
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    8266701100
    1 BOTTLE, DROPPER in 1 CARTON (82667-011-00) / 1 mL in 1 BOTTLE, DROPPER
  • ndc11
    8266701105
    1 BOTTLE, DROPPER in 1 CARTON (82667-011-05) / 5 mL in 1 BOTTLE, DROPPER

Annotations

UNII (FDA Substance ID)
7S5I7G3JQL
DEXAMETHASONE
RxCUI 3264
Orange Book
N050818
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "7S5I7G3JQL",
    "rxcui": "3264",
    "inchikey": "UREBDLICKHMUKA-CXSFZGCWSA-N",
    "display_name": "DEXAMETHASONE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "OPHTHALMIC",
  "spl_meta": {
    "7f310e0e-0d3b-493d-b6c4-238493a2a9b9": {
      "match": "brand_token",
      "title": "TOBRADEX (TOBRAMYCIN AND DEXAMETHASONE) OINTMENT [NOVARTIS PHARMACEUTICALS CORPORATION]",
      "spl_version": "8",
      "published_date": "2025-09-29"
    }
  },
  "productid": "82667-011_31ba978f-7bc8-031f-e063-6394a90ae09c",
  "productndc": "82667-011",
  "dosage_form": "SUSPENSION/ DROPS",
  "orange_book": {
    "appl_no": "050818",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "0.05%;0.3%",
        "product_no": "001",
        "approval_date": "Feb 13, 2009"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "DEXAMETHASONE; TOBRAMYCIN",
  "proprietary_name": "Tobradex ST",
  "active_ingred_unit": "mg/mL; mg/mL",
  "application_number": "NDA050818",
  "marketing_category": "NDA",
  "nonproprietary_name": "tobramycin / dexamethasone",
  "start_marketing_date": "20250331",
  "active_numerator_strength": ".5; 3"
}

Related drugs

Other records sharing ATC code A01AC.

Access this data programmatically

Query Tobradex ST 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.