Dexycu

In shortageOrange BookUNIISPLATC A01AC02

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

Identification

ManufacturerEyePoint Pharmaceuticals US, Inc

CountryUS (United States)

ATC codeA01AC02

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
7187900101
1 VIAL, GLASS in 1 CARTON (71879-001-01) / .5 mL in 1 VIAL, GLASS

Annotations

UNII (FDA Substance ID)

7S5I7G3JQL

DEXAMETHASONE

RxCUI 3264

Orange Book

N208912

DailyMed SPL labels

1 version tracked

FDA shortage

Currently in shortage

Dexamethasone Sodium Phosphate Injection

Raw payload (JSON)

{
  "unii": {
    "unii": "7S5I7G3JQL",
    "rxcui": "3264",
    "inchikey": "UREBDLICKHMUKA-CXSFZGCWSA-N",
    "display_name": "DEXAMETHASONE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAOCULAR",
  "spl_meta": {
    "583d70ed-bc42-465b-983d-c770db58406f": {
      "match": "brand_token",
      "title": "DEXYCU (DEXAMETHASONE) INJECTION, SUSPENSION [EYEPOINT PHARMACEUTICALS US, INC]",
      "spl_version": "11",
      "published_date": "2025-12-04"
    }
  },
  "productid": "71879-001_44fdffcc-1f20-6598-e063-6294a90aba36",
  "productndc": "71879-001",
  "dosage_form": "INJECTION, SUSPENSION",
  "orange_book": {
    "appl_no": "208912",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "9%",
        "product_no": "001",
        "approval_date": "Feb 9, 2018"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "DEXAMETHASONE",
  "shortage_reason": "Dexamethasone Sodium Phosphate Injection",
  "shortage_status": "current",
  "proprietary_name": "Dexycu",
  "active_ingred_unit": "ug/.005mL",
  "application_number": "NDA208912",
  "marketing_category": "NDA",
  "nonproprietary_name": "dexamethasone",
  "start_marketing_date": "20180522",
  "active_numerator_strength": "517"
}

Related drugs

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