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United States · US · US:0065-8595_27fdd84a-2d62-4c79-afb0-5d5bd608fdfc

TRYPTYR

Orange BookUNIISPL

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

Identification

ManufacturerAlcon Laboratories, Inc.
CountryUS (United States)
ATC code
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    0065859501
    3 POUCH in 1 CARTON (0065-8595-01) / 5 VIAL in 1 POUCH / .4 mL in 1 VIAL
  • ndc11
    0065859502
    12 POUCH in 1 CARTON (0065-8595-02) / 5 VIAL in 1 POUCH / .4 mL in 1 VIAL

Annotations

UNII (FDA Substance ID)
1L7BVT4Z4Z
ACOLTREMON
Orange Book
N217370
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "1L7BVT4Z4Z",
    "rxcui": null,
    "inchikey": "HNSGVPAAXJJOPQ-XOKHGSTOSA-N",
    "display_name": "ACOLTREMON",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "OPHTHALMIC; TOPICAL",
  "spl_meta": {
    "2b7715a1-035c-4002-b582-5238efee5d58": {
      "match": "brand_token",
      "title": "TRYPTYR (ACOLTREMON) SOLUTION [ALCON LABORATORIES, INC.]",
      "spl_version": "6",
      "published_date": "2025-12-22"
    }
  },
  "productid": "0065-8595_27fdd84a-2d62-4c79-afb0-5d5bd608fdfc",
  "productndc": "0065-8595",
  "dosage_form": "SOLUTION",
  "orange_book": {
    "appl_no": "217370",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "0.003%",
        "product_no": "001",
        "approval_date": "May 28, 2025"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ACOLTREMON",
  "proprietary_name": "TRYPTYR",
  "active_ingred_unit": "mg/mL",
  "application_number": "NDA217370",
  "marketing_category": "NDA",
  "nonproprietary_name": "Acoltremon",
  "start_marketing_date": "20250723",
  "active_numerator_strength": ".03"
}

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