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United States · US · US:50090-6341_c04e9df0-32ec-4603-bb2d-249844721467

OLOPATADINE HYDROCHLORIDE

Orange BookUNIISPLATC R01AC08

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

Identification

ManufacturerA-S Medication Solutions
CountryUS (United States)
ATC codeR01AC08
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    5009063410
    1 BOTTLE, PLASTIC in 1 CARTON (50090-6341-0) / 5 mL in 1 BOTTLE, PLASTIC

Annotations

UNII (FDA Substance ID)
2XG66W44KF
OLOPATADINE HYDROCHLORIDE
RxCUI 236599
Orange Book
A204812
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": "50090-6341_c04e9df0-32ec-4603-bb2d-249844721467",
  "productndc": "50090-6341",
  "dosage_form": "SOLUTION",
  "orange_book": {
    "appl_no": "204812",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "EQ 0.1% BASE",
        "product_no": "001",
        "approval_date": "Dec 18, 2015"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "OLOPATADINE HYDROCHLORIDE",
  "proprietary_name": "OLOPATADINE HYDROCHLORIDE",
  "active_ingred_unit": "mg/mL",
  "application_number": "ANDA204812",
  "marketing_category": "ANDA",
  "nonproprietary_name": "OLOPATADINE HYDROCHLORIDE",
  "start_marketing_date": "20200715",
  "active_numerator_strength": "1"
}

Related drugs

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