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United States · US · US:63629-1089_5bfcacf9-13d1-41c2-aa7c-ad3d59643c8e

Morphine sulfate

In shortageOrange BookUNIISPLATC N02AA51

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

Identification

ManufacturerBryant Ranch Prepack
CountryUS (United States)
ATC codeN02AA51
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    6362910891
    100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (63629-1089-1)

Annotations

UNII (FDA Substance ID)
X3P646A2J0
MORPHINE SULFATE
RxCUI 30236
Orange Book
A078761
ABABABABAB
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": "63629-1089_5bfcacf9-13d1-41c2-aa7c-ad3d59643c8e",
  "productndc": "63629-1089",
  "dosage_form": "TABLET, FILM COATED, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "078761",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "15MG",
        "product_no": "001",
        "approval_date": "May 11, 2012"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "30MG",
        "product_no": "002",
        "approval_date": "May 11, 2012"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "60MG",
        "product_no": "003",
        "approval_date": "May 11, 2012"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "100MG",
        "product_no": "004",
        "approval_date": "May 11, 2012"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "200MG",
        "product_no": "005",
        "approval_date": "May 11, 2012"
      }
    ],
    "appl_type": "A"
  },
  "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": "ANDA078761",
  "marketing_category": "ANDA",
  "nonproprietary_name": "morphine sulfate",
  "start_marketing_date": "20120511",
  "active_numerator_strength": "60"
}

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