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United States · US · US:0023-9652_0315cd41-0cc8-44c3-82fc-501832cdb855

DURYSTA

Orange BookUNIISPLATC S01EE03

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

Identification

ManufacturerAllergan, Inc.
CountryUS (United States)
ATC codeS01EE03
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 0

No packs registered.

Annotations

UNII (FDA Substance ID)
QXS94885MZ
BIMATOPROST
RxCUI 283810
Orange Book
N211911
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "QXS94885MZ",
    "rxcui": "283810",
    "inchikey": "AQOKCDNYWBIDND-FTOWTWDKSA-N",
    "display_name": "BIMATOPROST",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRACAMERAL",
  "spl_meta": {
    "3f59da84-0bcc-4c84-b3e2-e215681ef341": {
      "match": "brand_token",
      "title": "DURYSTA (BIMATOPROST) IMPLANT [ALLERGAN, INC.]",
      "spl_version": "15",
      "published_date": "2025-02-17"
    }
  },
  "productid": "0023-9652_0315cd41-0cc8-44c3-82fc-501832cdb855",
  "productndc": "0023-9652",
  "dosage_form": "IMPLANT",
  "orange_book": {
    "appl_no": "211911",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "10MCG",
        "product_no": "001",
        "approval_date": "Mar 4, 2020"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "BIMATOPROST",
  "proprietary_name": "DURYSTA",
  "active_ingred_unit": "ug/1",
  "application_number": "NDA211911",
  "marketing_category": "NDA",
  "nonproprietary_name": "bimatoprost",
  "start_marketing_date": "20200304",
  "active_numerator_strength": "10"
}

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