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United States · US · US:70756-193_7d7eab12-f721-4092-8c18-7100544ade2b

Proparacaine hydrochloride

Orange BookUNIISPLATC S01HA04

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

Identification

ManufacturerLifestar Pharma LLC
CountryUS (United States)
ATC codeS01HA04
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    7075619335
    1 BOTTLE, DROPPER in 1 CARTON (70756-193-35) / 15 mL in 1 BOTTLE, DROPPER

Annotations

UNII (FDA Substance ID)
U96OL57GOY
PROPARACAINE HYDROCHLORIDE
RxCUI 227778
Orange Book
A219136
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": "70756-193_7d7eab12-f721-4092-8c18-7100544ade2b",
  "productndc": "70756-193",
  "dosage_form": "SOLUTION/ DROPS",
  "orange_book": {
    "appl_no": "219136",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AT",
        "strength": "0.5%",
        "product_no": "001",
        "approval_date": "May 21, 2025"
      }
    ],
    "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": "ANDA219136",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Proparacaine hydrochloride",
  "start_marketing_date": "20250521",
  "active_numerator_strength": "5"
}

Related drugs

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