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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
- ndc1100658595013 POUCH in 1 CARTON (0065-8595-01) / 5 VIAL in 1 POUCH / .4 mL in 1 VIAL
- ndc11006585950212 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"
}Access this data programmatically
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