Back to search
🇺🇸

United States · US · US:70512-520_45728450-eb13-7314-e063-6394a90ae6d1

Olopatadine Hcl

Orange BookUNIISPLATC R01AC08

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

Identification

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

Packs · 1

  • ndc11
    7051252005
    1 BOTTLE, PLASTIC in 1 CARTON (70512-520-05) / 5 mL in 1 BOTTLE, PLASTIC

Annotations

UNII (FDA Substance ID)
2XG66W44KF
OLOPATADINE HYDROCHLORIDE
RxCUI 236599
Orange Book
A203152
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": "70512-520_45728450-eb13-7314-e063-6394a90ae6d1",
  "productndc": "70512-520",
  "dosage_form": "SOLUTION/ DROPS",
  "orange_book": {
    "appl_no": "203152",
    "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 Hcl",
  "active_ingred_unit": "mg/mL",
  "application_number": "ANDA203152",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Olopatadine Hcl",
  "start_marketing_date": "20220705",
  "active_numerator_strength": "1"
}

Related drugs

Other records sharing ATC code R01AC08.

Access this data programmatically

Query Olopatadine Hcl and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.