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United States · US · US:50090-2364_c7b72c56-5267-471a-8370-55a0f0122e5f

Tetracaine Hydrochloride

Orange BookUNIISPLATC C05AD02

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

Identification

ManufacturerA-S Medication Solutions
CountryUS (United States)
ATC codeC05AD02
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    5009023641
    4 mL in 1 BOTTLE, DROPPER (50090-2364-1)

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": "50090-2364_c7b72c56-5267-471a-8370-55a0f0122e5f",
  "productndc": "50090-2364",
  "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"
}

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