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United States · US · US:0054-0235_c89c4f71-eab3-4b74-b098-fcd31d5aa0dd

Morphine Sulfate

In shortageOrange BookUNIISPLATC N02AA51

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

Identification

ManufacturerHikma Pharmaceuticals USA Inc.
CountryUS (United States)
ATC codeN02AA51
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    0054023524
    100 BLISTER PACK in 1 CARTON (0054-0235-24) / 1 TABLET in 1 BLISTER PACK
  • ndc11
    0054023525
    100 TABLET in 1 BOTTLE (0054-0235-25)

Annotations

UNII (FDA Substance ID)
X3P646A2J0
MORPHINE SULFATE
RxCUI 30236
Orange Book
N022207
ABAB
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Morphine Sulfate Injection
Raw payload (JSON)
{
  "unii": {
    "unii": "X3P646A2J0",
    "rxcui": "30236",
    "inchikey": "GRVOTVYEFDAHCL-RTSZDRIGSA-N",
    "display_name": "MORPHINE SULFATE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "8d800d8e-8fe2-453b-a8ac-dcf7c47e55fc": {
      "match": "brand_token",
      "title": "MORPHINE SULFATE SOLUTION [PRECISION DOSE INC.]",
      "spl_version": "9",
      "published_date": "2026-05-29"
    }
  },
  "productid": "0054-0235_c89c4f71-eab3-4b74-b098-fcd31d5aa0dd",
  "productndc": "0054-0235",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "022207",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "15MG",
        "product_no": "001",
        "approval_date": "Mar 17, 2008"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "30MG",
        "product_no": "002",
        "approval_date": "Mar 17, 2008"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": "CII",
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "MORPHINE SULFATE",
  "shortage_reason": "Morphine Sulfate Injection",
  "shortage_status": "current",
  "proprietary_name": "Morphine Sulfate",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA022207",
  "marketing_category": "NDA",
  "nonproprietary_name": "Morphine Sulfate",
  "start_marketing_date": "20080317",
  "active_numerator_strength": "15"
}

Related drugs

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