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United States · US · US:0065-0741_e5c0f202-3d32-4b47-8d45-e1d031ff7ce9

Tetracaine Hydrochloride

Orange BookUNIISPLATC C05AD02

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

Identification

ManufacturerAlcon Laboratories, Inc.
CountryUS (United States)
ATC codeC05AD02
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    0065074114
    12 BLISTER PACK in 1 CARTON (0065-0741-14) / 1 BOTTLE, DROPPER in 1 BLISTER PACK / 4 mL in 1 BOTTLE, DROPPER

Annotations

UNII (FDA Substance ID)
5NF5D4OPCI
TETRACAINE HYDROCHLORIDE
RxCUI 91189
Orange Book
N208135
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "5NF5D4OPCI",
    "rxcui": "91189",
    "inchikey": "PPWHTZKZQNXVAE-UHFFFAOYSA-N",
    "display_name": "TETRACAINE HYDROCHLORIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "OPHTHALMIC",
  "spl_meta": {
    "f12d5944-0d6c-43ff-89fd-e0b5669e9b4a": {
      "match": "brand_token",
      "title": "TETRACAINE HYDROCHLORIDE SOLUTION/ DROPS [BAUSCH & LOMB AMERICAS INC.]",
      "spl_version": "4",
      "published_date": "2026-02-09"
    }
  },
  "productid": "0065-0741_e5c0f202-3d32-4b47-8d45-e1d031ff7ce9",
  "productndc": "0065-0741",
  "dosage_form": "SOLUTION",
  "orange_book": {
    "appl_no": "208135",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "0.5%",
        "product_no": "001",
        "approval_date": "Feb 29, 2016"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "TETRACAINE HYDROCHLORIDE",
  "proprietary_name": "Tetracaine Hydrochloride",
  "active_ingred_unit": "mg/mL",
  "application_number": "NDA208135",
  "marketing_category": "NDA",
  "nonproprietary_name": "tetracaine hydrochloride",
  "start_marketing_date": "20161102",
  "active_numerator_strength": "5"
}

Related drugs

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