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United States · US · US:68071-4368_1a555cda-0c40-ba30-e063-6394a90a3525

Proparacaine Hydrochloride

Orange BookUNIISPLATC S01HA04

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

Identification

ManufacturerNuCare Pharmaceuticals,Inc.
CountryUS (United States)
ATC codeS01HA04
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    6807143685
    15 mL in 1 BOX (68071-4368-5)

Annotations

UNII (FDA Substance ID)
U96OL57GOY
PROPARACAINE HYDROCHLORIDE
RxCUI 227778
Orange Book
A040074
AT
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "U96OL57GOY",
    "rxcui": "227778",
    "inchikey": "BFUUJUGQJUTPAF-UHFFFAOYSA-N",
    "display_name": "PROPARACAINE HYDROCHLORIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "OPHTHALMIC",
  "spl_meta": {
    "1d257859-cd1d-485f-a4d5-dbb33c1ec197": {
      "match": "brand_token",
      "title": "PROPARACAINE HYDROCHLORIDE SOLUTION/ DROPS [SPORTPHARM LLC]",
      "spl_version": "2",
      "published_date": "2026-04-27"
    }
  },
  "productid": "68071-4368_1a555cda-0c40-ba30-e063-6394a90a3525",
  "productndc": "68071-4368",
  "dosage_form": "SOLUTION/ DROPS",
  "orange_book": {
    "appl_no": "040074",
    "products": [
      {
        "rs": true,
        "rld": false,
        "te_code": "AT",
        "strength": "0.5%",
        "product_no": "001",
        "approval_date": "Sep 29, 1995"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "PROPARACAINE HYDROCHLORIDE",
  "proprietary_name": "Proparacaine Hydrochloride",
  "active_ingred_unit": "mg/mL",
  "application_number": "ANDA040074",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Proparacaine Hydrochloride",
  "start_marketing_date": "19950929",
  "active_numerator_strength": "5"
}

Related drugs

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