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United States · US · US:54799-920_575c94a5-ec98-4050-a450-2a6c4ef95641

Retaine Allergy

Orange BookUNIISPLATC R01AC08

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

Identification

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

Packs · 1

  • ndc11
    5479992025
    2.5 mL in 1 BOTTLE, PLASTIC (54799-920-25)

Annotations

UNII (FDA Substance ID)
2XG66W44KF
OLOPATADINE HYDROCHLORIDE
RxCUI 236599
Orange Book
A209420
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": {
    "a5aaaf06-772d-44d3-8601-f978ddc48ad7": {
      "match": "brand_token",
      "title": "RETAINE ULTRA PF (POLYETHYLENE GLYCOL) LIQUID [OCUSOFT LLC]",
      "spl_version": "1",
      "published_date": "2026-05-21"
    }
  },
  "productid": "54799-920_575c94a5-ec98-4050-a450-2a6c4ef95641",
  "productndc": "54799-920",
  "dosage_form": "SOLUTION/ DROPS",
  "orange_book": {
    "appl_no": "209420",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "EQ 0.2% BASE",
        "product_no": "001",
        "approval_date": "Apr 29, 2019"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "OLOPATADINE HYDROCHLORIDE",
  "proprietary_name": "Retaine Allergy",
  "active_ingred_unit": "mg/2.5mL",
  "application_number": "ANDA209420",
  "marketing_category": "ANDA",
  "nonproprietary_name": "olopatadine hydrochloride",
  "start_marketing_date": "20240705",
  "active_numerator_strength": "5"
}

Related drugs

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