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United States · US · US:70000-0717_32bff197-0006-d853-e063-6394a90a8cc2

Leader Olopatadine Hydrochloride Ophthalmic Solution

Orange BookUNIISPLATC R01AC08

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

Identification

ManufacturerCARDINAL HEALTH
CountryUS (United States)
ATC codeR01AC08
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    7000007171
    1 BOTTLE in 1 CARTON (70000-0717-1) / 5 mL in 1 BOTTLE

Annotations

UNII (FDA Substance ID)
2XG66W44KF
OLOPATADINE HYDROCHLORIDE
RxCUI 236599
Orange Book
A206046
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": {
    "12971fb2-2314-4443-bf70-b7eb5859b148": {
      "match": "brand_token",
      "title": "LEADER MUCUS RELIEF D (GUAIFENESIN, PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, MULTILAYER, EXTENDED RELEASE [CARDINAL HEALTH 110, LLC. DBA LEADER]",
      "spl_version": "3",
      "published_date": "2026-06-01"
    }
  },
  "productid": "70000-0717_32bff197-0006-d853-e063-6394a90a8cc2",
  "productndc": "70000-0717",
  "dosage_form": "SOLUTION",
  "orange_book": {
    "appl_no": "206046",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "EQ 0.1% BASE",
        "product_no": "001",
        "approval_date": "Jul 26, 2017"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "OLOPATADINE HYDROCHLORIDE",
  "proprietary_name": "Leader Olopatadine Hydrochloride Ophthalmic Solution",
  "active_ingred_unit": "mg/mL",
  "application_number": "ANDA206046",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Olopatadine Hydrochloride Ophthalmic Solution",
  "start_marketing_date": "20250415",
  "active_numerator_strength": "1"
}

Related drugs

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