Morphine Sulfate

In shortageOrange BookUNIISPLATC N02AA51

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

Identification

ManufacturerHospira, Inc.

CountryUS (United States)

ATC codeN02AA51

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 2

ndc11
0409189301
10 CARTRIDGE in 1 CARTON (0409-1893-01) / 1 mL in 1 CARTRIDGE (0409-1893-03)
ndc11
0409189323
10 SYRINGE in 1 CELLO PACK (0409-1893-23) / 1 mL in 1 SYRINGE (0409-1893-13)

Annotations

UNII (FDA Substance ID)

X3P646A2J0

MORPHINE SULFATE

RxCUI 30236

Orange Book

N202515

APAPAPAP

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": "INTRAVENOUS",
  "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": "0409-1893_56671cfe-7548-442e-a2b5-ffebebf65ade",
  "productndc": "0409-1893",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "202515",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": "AP",
        "strength": "2MG/ML",
        "product_no": "001",
        "approval_date": "Nov 14, 2011"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AP",
        "strength": "4MG/ML",
        "product_no": "002",
        "approval_date": "Nov 14, 2011"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AP",
        "strength": "8MG/ML",
        "product_no": "003",
        "approval_date": "Nov 14, 2011"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AP",
        "strength": "10MG/ML",
        "product_no": "004",
        "approval_date": "Nov 14, 2011"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "15MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",
        "product_no": "005",
        "approval_date": "Nov 14, 2011"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "50MG/ML",
        "product_no": "006",
        "approval_date": "Apr 29, 2021"
      }
    ],
    "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/mL",
  "application_number": "NDA202515",
  "marketing_category": "NDA",
  "nonproprietary_name": "MORPHINE SULFATE",
  "start_marketing_date": "20120820",
  "active_numerator_strength": "10"
}

Related drugs

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