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United States · US · US:75907-343_5b76cadb-7cc6-a76c-463a-e87c4b1403f9

Eye Allergy Itch Relief

Orange BookUNIISPLATC R01AC08

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

Identification

ManufacturerDr. Reddy's Laboratories Inc.
CountryUS (United States)
ATC codeR01AC08
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    7590734325
    2 BOTTLE in 1 CARTON (75907-343-25) / 2.5 mL in 1 BOTTLE (75907-343-02)

Annotations

UNII (FDA Substance ID)
2XG66W44KF
OLOPATADINE HYDROCHLORIDE
RxCUI 236599
Orange Book
A213514
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": "75907-343_5b76cadb-7cc6-a76c-463a-e87c4b1403f9",
  "productndc": "75907-343",
  "dosage_form": "SOLUTION",
  "orange_book": {
    "appl_no": "213514",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "EQ 0.7% BASE",
        "product_no": "001",
        "approval_date": "Jan 6, 2026"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "OLOPATADINE HYDROCHLORIDE",
  "proprietary_name": "Eye Allergy Itch Relief",
  "active_ingred_unit": "mg/mL",
  "application_number": "ANDA213514",
  "marketing_category": "ANDA",
  "nonproprietary_name": "olopatadine hydrochloride ophthalmic",
  "start_marketing_date": "20260115",
  "active_numerator_strength": "7"
}

Related drugs

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