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United States · US · US:71776-005_42db6120-d37f-9001-e063-6294a90af191

NATACYN

Orange BookUNIISPLATC S01AA10

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

Identification

ManufacturerEyevance Pharmaceuticals, LLC
CountryUS (United States)
ATC codeS01AA10
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 0

No packs registered.

Annotations

UNII (FDA Substance ID)
8O0C852CPO
NATAMYCIN
RxCUI 7268
Orange Book
N050514
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "8O0C852CPO",
    "rxcui": "7268",
    "inchikey": "NCXMLFZGDNKEPB-FFPOYIOWSA-N",
    "display_name": "NATAMYCIN",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "OPHTHALMIC",
  "spl_meta": {
    "2818fcb8-5bac-41fb-864e-3b598308a428": {
      "match": "brand_token",
      "title": "NATACYN (NATAMYCIN) SUSPENSION/ DROPS [EYEVANCE PHARMACEUTICALS, LLC]",
      "spl_version": "11",
      "published_date": "2025-11-17"
    }
  },
  "productid": "71776-005_42db6120-d37f-9001-e063-6294a90af191",
  "productndc": "71776-005",
  "dosage_form": "SUSPENSION/ DROPS",
  "orange_book": {
    "appl_no": "050514",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "5%",
        "product_no": "001",
        "approval_date": "Approved Prior to Jan 1, 1982"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "NATAMYCIN",
  "proprietary_name": "NATACYN",
  "active_ingred_unit": "mg/mL",
  "application_number": "NDA050514",
  "marketing_category": "NDA",
  "nonproprietary_name": "natamycin",
  "start_marketing_date": "20210612",
  "active_numerator_strength": "50"
}

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