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United States · US · US:70000-0054_5104f5a9-ebf6-c7a1-6eb2-f43a025f699f

Eye Allergy Itch and Redness Relief

Orange BookUNIISPLATC R01AC08

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

Identification

ManufacturerCARDINAL HEALTH 110, LLC. DBA LEADER
CountryUS (United States)
ATC codeR01AC08
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    7000000541
    1 BOTTLE, DROPPER in 1 CARTON (70000-0054-1) / 5 mL in 1 BOTTLE, DROPPER

Annotations

UNII (FDA Substance ID)
2XG66W44KF
OLOPATADINE HYDROCHLORIDE
RxCUI 236599
Orange Book
A209619
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "2XG66W44KF",
    "rxcui": "236599",
    "inchikey": "HVRLZEKDTUEKQH-NOILCQHBSA-N",
    "display_name": "OLOPATADINE HYDROCHLORIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "OPHTHALMIC",
  "spl_meta": {
    "52c62397-58f1-d34d-e063-6294a90a6faf": {
      "match": "brand_token",
      "title": "EYE ITCH RELIEF (KETOTIFEN FUMARATE) SOLUTION [REDPHARM DRUG]",
      "spl_version": "1",
      "published_date": "2026-05-28"
    }
  },
  "productid": "70000-0054_5104f5a9-ebf6-c7a1-6eb2-f43a025f699f",
  "productndc": "70000-0054",
  "dosage_form": "SOLUTION/ DROPS",
  "orange_book": {
    "appl_no": "209619",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "EQ 0.1% BASE",
        "product_no": "001",
        "approval_date": "Aug 2, 2019"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "OLOPATADINE HYDROCHLORIDE",
  "proprietary_name": "Eye Allergy Itch and Redness Relief",
  "active_ingred_unit": "mg/mL",
  "application_number": "ANDA209619",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Olopatadine Hydrochloride",
  "start_marketing_date": "20210115",
  "active_numerator_strength": "1"
}

Related drugs

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