DEXTENZA

In shortageOrange BookUNIISPLATC A01AC02

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

Identification

ManufacturerOcular Therapeutix, Inc.

CountryUS (United States)

ATC codeA01AC02

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 3

ndc11
7038220401
1 POUCH in 1 BOX, UNIT-DOSE (70382-204-01) / 1 INSERT in 1 POUCH (70382-204-88)
ndc11
7038220410
10 POUCH in 1 BOX, UNIT-DOSE (70382-204-10) / 1 INSERT in 1 POUCH (70382-204-88)
ndc11
7038220499
1 POUCH in 1 BOX, UNIT-DOSE (70382-204-99) / 1 INSERT in 1 POUCH (70382-204-88)

Annotations

UNII (FDA Substance ID)

7S5I7G3JQL

DEXAMETHASONE

RxCUI 3264

Orange Book

N208742

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": "INTRACANALICULAR; OPHTHALMIC",
  "spl_meta": {
    "7514e6b8-c33f-4fbf-8810-ef520e1eb4bd": {
      "match": "brand_token",
      "title": "DEXTENZA (DEXAMETHASONE) INSERT [OCULAR THERAPEUTIX, INC.\n]",
      "spl_version": "18",
      "published_date": "2026-03-09"
    }
  },
  "productid": "70382-204_ad2305a4-f888-4800-a31e-1fff3ffee20d",
  "productndc": "70382-204",
  "dosage_form": "INSERT",
  "orange_book": {
    "appl_no": "208742",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "0.4MG",
        "product_no": "001",
        "approval_date": "Nov 30, 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": "DEXTENZA",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA208742",
  "marketing_category": "NDA",
  "nonproprietary_name": "dexamethasone",
  "start_marketing_date": "20190107",
  "active_numerator_strength": ".4"
}

Related drugs

Other records sharing ATC code A01AC02.

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