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United States · US · US:24208-967_2cf6fd10-a683-a6cb-e063-6394a90a3ec1

OLOPATADINE HYDROCHLORIDE

Orange BookUNIISPLATC R01AC08

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

Identification

ManufacturerBausch & Lomb Incorporated
CountryUS (United States)
ATC codeR01AC08
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 3

  • ndc11
    2420896701
    1 BOTTLE, PLASTIC in 1 CARTON (24208-967-01) / 3.5 mL in 1 BOTTLE, PLASTIC
  • ndc11
    2420896702
    2 BOTTLE, PLASTIC in 1 CARTON (24208-967-02) / 3.5 mL in 1 BOTTLE, PLASTIC
  • ndc11
    2420896703
    3 BOTTLE, PLASTIC in 1 CARTON (24208-967-03) / 3.5 mL in 1 BOTTLE, PLASTIC

Annotations

UNII (FDA Substance ID)
2XG66W44KF
OLOPATADINE HYDROCHLORIDE
RxCUI 236599
Orange Book
A206087
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": "24208-967_2cf6fd10-a683-a6cb-e063-6394a90a3ec1",
  "productndc": "24208-967",
  "dosage_form": "SOLUTION",
  "orange_book": {
    "appl_no": "206087",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "EQ 0.2% BASE",
        "product_no": "001",
        "approval_date": "Dec 5, 2017"
      }
    ],
    "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": "ANDA206087",
  "marketing_category": "ANDA",
  "nonproprietary_name": "OLOPATADINE HYDROCHLORIDE",
  "start_marketing_date": "20250120",
  "active_numerator_strength": "2"
}

Related drugs

Other records sharing ATC code R01AC08.

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