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United States · US · US:0023-3348_007c310d-2cfe-4c54-a27e-693e0d7fa78a

OZURDEX

In shortageOrange BookUNIISPLATC A01AC02

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

Identification

ManufacturerAllergan, Inc.
CountryUS (United States)
ATC codeA01AC02
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    0023334807
    1 POUCH in 1 CARTON (0023-3348-07) / 1 IMPLANT in 1 POUCH
  • ndc11
    0023334808
    1 POUCH in 1 CARTON (0023-3348-08) / 1 IMPLANT in 1 POUCH

Annotations

UNII (FDA Substance ID)
7S5I7G3JQL
DEXAMETHASONE
RxCUI 3264
Orange Book
N022315
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": "INTRAVITREAL",
  "spl_meta": {
    "4b204f44-6e8a-4d17-803c-268f0b04679f": {
      "match": "brand_token",
      "title": "OZURDEX (DEXAMETHASONE) IMPLANT [ALLERGAN, INC.]",
      "spl_version": "38",
      "published_date": "2026-03-18"
    }
  },
  "productid": "0023-3348_007c310d-2cfe-4c54-a27e-693e0d7fa78a",
  "productndc": "0023-3348",
  "dosage_form": "IMPLANT",
  "orange_book": {
    "appl_no": "022315",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "0.7MG",
        "product_no": "001",
        "approval_date": "Jun 17, 2009"
      }
    ],
    "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": "OZURDEX",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA022315",
  "marketing_category": "NDA",
  "nonproprietary_name": "dexamethasone",
  "start_marketing_date": "20090901",
  "active_numerator_strength": ".7"
}

Related drugs

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