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United States · US · US:0023-2181_fb99e487-9880-4bb9-9271-7bf042a4f0f8

Acular

In shortageOrange BookUNIISPLATC M01AB

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

Identification

ManufacturerAllergan, Inc.
CountryUS (United States)
ATC codeM01AB
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    0023218105
    1 BOTTLE, DROPPER in 1 CARTON (0023-2181-05) / 5 mL in 1 BOTTLE, DROPPER

Annotations

UNII (FDA Substance ID)
4EVE5946BQ
KETOROLAC TROMETHAMINE
RxCUI 28200
Orange Book
N019700
AT
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Ketorolac Tromethamine Injection
Raw payload (JSON)
{
  "unii": {
    "unii": "4EVE5946BQ",
    "rxcui": "28200",
    "inchikey": "BWHLPLXXIDYSNW-UHFFFAOYSA-N",
    "display_name": "KETOROLAC TROMETHAMINE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "OPHTHALMIC",
  "spl_meta": {
    "c94644d3-7b64-4f3d-a0c7-12c77466a0fc": {
      "match": "brand_token",
      "title": "ACULAR (KETOROLAC TROMETHAMINE) SOLUTION/ DROPS [ALLERGAN, INC.]",
      "spl_version": "16",
      "published_date": "2025-10-02"
    }
  },
  "productid": "0023-2181_fb99e487-9880-4bb9-9271-7bf042a4f0f8",
  "productndc": "0023-2181",
  "dosage_form": "SOLUTION/ DROPS",
  "orange_book": {
    "appl_no": "019700",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": "AT",
        "strength": "0.5%",
        "product_no": "001",
        "approval_date": "Nov 9, 1992"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "KETOROLAC TROMETHAMINE",
  "shortage_reason": "Ketorolac Tromethamine Injection",
  "shortage_status": "current",
  "proprietary_name": "Acular",
  "active_ingred_unit": "mg/mL",
  "application_number": "NDA019700",
  "marketing_category": "NDA",
  "nonproprietary_name": "Ketorolac Tromethamine",
  "start_marketing_date": "19921201",
  "active_numerator_strength": "5"
}

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