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United States · US · US:0832-0228_3984af25-b79e-1fe0-e063-6394a90ac936

Morphine Sulfate

In shortageOrange BookUNIISPLATC N02AA51

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

Identification

ManufacturerUpsher-Smith Laboratories, LLC
CountryUS (United States)
ATC codeN02AA51
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    0832022800
    100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0832-0228-00)
  • ndc11
    0832022850
    500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0832-0228-50)

Annotations

UNII (FDA Substance ID)
X3P646A2J0
MORPHINE SULFATE
RxCUI 30236
Orange Book
A202104
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": "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": "0832-0228_3984af25-b79e-1fe0-e063-6394a90ac936",
  "productndc": "0832-0228",
  "dosage_form": "CAPSULE, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "202104",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "10MG",
        "product_no": "001",
        "approval_date": "Jun 3, 2013"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "20MG",
        "product_no": "002",
        "approval_date": "Jun 3, 2013"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "30MG",
        "product_no": "003",
        "approval_date": "Jun 3, 2013"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "50MG",
        "product_no": "004",
        "approval_date": "Jun 3, 2013"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "60MG",
        "product_no": "005",
        "approval_date": "Jun 3, 2013"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "80MG",
        "product_no": "006",
        "approval_date": "Jun 3, 2013"
      },
      {
        "rs": true,
        "rld": false,
        "te_code": null,
        "strength": "100MG",
        "product_no": "007",
        "approval_date": "Jun 3, 2013"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": "CII",
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "MORPHINE SULFATE",
  "shortage_reason": "Morphine Sulfate Tablet",
  "shortage_status": "current",
  "proprietary_name": "Morphine Sulfate",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA202104",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Morphine Sulfate",
  "start_marketing_date": "20130630",
  "active_numerator_strength": "50"
}

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