Duramorph

In shortageOrange BookUNIISPLATC N02AA51

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

Identification

ManufacturerHikma Pharmaceuticals USA Inc.

CountryUS (United States)

ATC codeN02AA51

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
0641602010
10 AMPULE in 1 CARTON (0641-6020-10) / 10 mL in 1 AMPULE (0641-6020-01)

Annotations

UNII (FDA Substance ID)

X3P646A2J0

MORPHINE SULFATE

RxCUI 30236

Orange Book

N018565

APAPAPAP

DailyMed SPL labels

1 version tracked

FDA shortage

Currently in shortage

Morphine Sulfate Tablet

Raw payload (JSON)

{
  "unii": {
    "unii": "X3P646A2J0",
    "rxcui": "30236",
    "inchikey": "GRVOTVYEFDAHCL-RTSZDRIGSA-N",
    "display_name": "MORPHINE SULFATE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "EPIDURAL; INTRATHECAL; INTRAVENOUS",
  "spl_meta": {
    "ebb18761-e5c4-4238-bb84-f9549f500210": {
      "match": "brand_token",
      "title": "DURAMORPH (MORPHINE SULFATE) INJECTION [HIKMA PHARMACEUTICALS USA INC.]",
      "spl_version": "11",
      "published_date": "2026-01-30"
    }
  },
  "productid": "0641-6020_aa74af85-7068-4254-9a79-c7f3792044a6",
  "productndc": "0641-6020",
  "dosage_form": "INJECTION",
  "orange_book": {
    "appl_no": "018565",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": "AP",
        "strength": "0.5MG/ML",
        "product_no": "001",
        "approval_date": "Sep 18, 1984"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AP",
        "strength": "1MG/ML",
        "product_no": "002",
        "approval_date": "Sep 18, 1984"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AP",
        "strength": "10MG/ML",
        "product_no": "003",
        "approval_date": "Jul 19, 1991"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AP",
        "strength": "25MG/ML",
        "product_no": "004",
        "approval_date": "Jul 19, 1991"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": "CII",
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "MORPHINE SULFATE",
  "shortage_reason": "Morphine Sulfate Tablet",
  "shortage_status": "current",
  "proprietary_name": "Duramorph",
  "active_ingred_unit": "mg/mL",
  "application_number": "NDA018565",
  "marketing_category": "NDA",
  "nonproprietary_name": "morphine sulfate",
  "start_marketing_date": "19840918",
  "active_numerator_strength": ".5"
}

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