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United States · US · US:50090-1923_5c8706f5-f8f3-48a7-8b99-0fa722b7d178

Proparacaine Hydrochloride

Orange BookUNIISPLATC S01HA04

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

Identification

ManufacturerA-S Medication Solutions
CountryUS (United States)
ATC codeS01HA04
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    5009019230
    1 BOTTLE, DROPPER in 1 CARTON (50090-1923-0) / 15 mL in 1 BOTTLE, DROPPER

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": "50090-1923_5c8706f5-f8f3-48a7-8b99-0fa722b7d178",
  "productndc": "50090-1923",
  "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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