XALATAN

Orange BookUNIISPLATC S01EE01

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerViatris Specialty LLC

CountryUS (United States)

ATC codeS01EE01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
5815141935
1 BOTTLE, DROPPER in 1 CARTON (58151-419-35) / 2.5 mL in 1 BOTTLE, DROPPER

Annotations

UNII (FDA Substance ID)

6Z5B6HVF6O

LATANOPROST

RxCUI 43611

Orange Book

N020597

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "6Z5B6HVF6O",
    "rxcui": "43611",
    "inchikey": "GGXICVAJURFBLW-CEYXHVGTSA-N",
    "display_name": "LATANOPROST",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "OPHTHALMIC",
  "spl_meta": {
    "a98595b3-9f47-48e0-b18d-550a2095f264": {
      "match": "brand_token",
      "title": "XALATAN (LATANOPROST) SOLUTION/ DROPS [VIATRIS SPECIALTY LLC]",
      "spl_version": "2",
      "published_date": "2024-10-25"
    }
  },
  "productid": "58151-419_45489b8b-2aab-4336-8552-1524493289f9",
  "productndc": "58151-419",
  "dosage_form": "SOLUTION/ DROPS",
  "orange_book": {
    "appl_no": "020597",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": "AT",
        "strength": "0.005%",
        "product_no": "001",
        "approval_date": "Jun 5, 1996"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "LATANOPROST",
  "proprietary_name": "XALATAN",
  "active_ingred_unit": "ug/mL",
  "application_number": "NDA020597",
  "marketing_category": "NDA",
  "nonproprietary_name": "Latanoprost",
  "start_marketing_date": "20241022",
  "active_numerator_strength": "50"
}

Related drugs

Other records sharing ATC code S01EE01.

Access this data programmatically

Query XALATAN 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.

Get a free API key Read the API docs