Back to search
🇺🇸

United States · US · US:65162-890_270f118a-97b1-420b-8504-bfc600008903

Olopatadine Hydrochloride

Orange BookUNIISPLATC R01AC08

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

Identification

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

Packs · 1

  • ndc11
    6516289023
    1 BOTTLE, SPRAY in 1 CARTON (65162-890-23) / 665 SPRAY, METERED in 1 BOTTLE, SPRAY

Annotations

UNII (FDA Substance ID)
2XG66W44KF
OLOPATADINE HYDROCHLORIDE
RxCUI 236599
Orange Book
A210901
AB
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": "NASAL",
  "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": "65162-890_270f118a-97b1-420b-8504-bfc600008903",
  "productndc": "65162-890",
  "dosage_form": "SPRAY, METERED",
  "orange_book": {
    "appl_no": "210901",
    "products": [
      {
        "rs": true,
        "rld": false,
        "te_code": "AB",
        "strength": "0.665MG/SPRAY",
        "product_no": "001",
        "approval_date": "Jan 28, 2020"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "OLOPATADINE HYDROCHLORIDE",
  "proprietary_name": "Olopatadine Hydrochloride",
  "active_ingred_unit": "ug/1",
  "application_number": "ANDA210901",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Olopatadine Hydrochloride",
  "start_marketing_date": "20200203",
  "active_numerator_strength": "665"
}

Related drugs

Other records sharing ATC code R01AC08.

Access this data programmatically

Query Olopatadine Hydrochloride 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.