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United States · US · US:70069-017_9cb75ee7-d7e0-4f19-8088-05426d8ea407

Olopatadine

Orange BookUNIISPLATC R01AC08

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

Identification

ManufacturerSomerset Therapeutics, LLC
CountryUS (United States)
ATC codeR01AC08
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    7006901701
    1 BOTTLE, PLASTIC in 1 CARTON (70069-017-01) / 5 mL in 1 BOTTLE, PLASTIC

Annotations

UNII (FDA Substance ID)
2XG66W44KF
OLOPATADINE HYDROCHLORIDE
RxCUI 236599
Orange Book
A206306
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": {
    "96ad3623-f7cc-4c1c-aa65-d89077873b69": {
      "match": "brand_token",
      "title": "OLOPATADINE HYDROCHLORIDE (OLOPATADINE HYDROCHLORIDE OPHTHALMIC SOLUTION) SOLUTION/ DROPS [RUGBY LABORATORIES]",
      "spl_version": "4",
      "published_date": "2026-05-22"
    }
  },
  "productid": "70069-017_9cb75ee7-d7e0-4f19-8088-05426d8ea407",
  "productndc": "70069-017",
  "dosage_form": "SOLUTION/ DROPS",
  "orange_book": {
    "appl_no": "206306",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "EQ 0.1% BASE",
        "product_no": "001",
        "approval_date": "Dec 7, 2015"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "OLOPATADINE HYDROCHLORIDE",
  "proprietary_name": "Olopatadine",
  "active_ingred_unit": "mg/mL",
  "application_number": "ANDA206306",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Olopatadine",
  "start_marketing_date": "20240415",
  "active_numerator_strength": "1"
}

Related drugs

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