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United States · US · US:70069-597_8d8c6ec7-7369-4f34-88bf-e8827fb87ef0

Tetracaine Hydrochloride

Orange BookUNIISPLATC C05AD02

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

Identification

ManufacturerSomerset Therapeutics, LLC
CountryUS (United States)
ATC codeC05AD02
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    7006959701
    1 BOTTLE in 1 CARTON (70069-597-01) / 15 mL in 1 BOTTLE

Annotations

UNII (FDA Substance ID)
5NF5D4OPCI
TETRACAINE HYDROCHLORIDE
RxCUI 91189
Orange Book
A217227
AB1
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": "70069-597_8d8c6ec7-7369-4f34-88bf-e8827fb87ef0",
  "productndc": "70069-597",
  "dosage_form": "SOLUTION",
  "orange_book": {
    "appl_no": "217227",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB1",
        "strength": "0.5%",
        "product_no": "001",
        "approval_date": "Dec 20, 2024"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "TETRACAINE HYDROCHLORIDE",
  "proprietary_name": "Tetracaine Hydrochloride",
  "active_ingred_unit": "mg/mL",
  "application_number": "ANDA217227",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Tetracaine Hydrochloride",
  "start_marketing_date": "20241223",
  "active_numerator_strength": "5"
}

Related drugs

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