Morphine sulfate

In shortageOrange BookUNIISPLATC N02AA51

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

Identification

ManufacturerSun Pharmaceutical Industries, Inc.

CountryUS (United States)

ATC codeN02AA51

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 4

ndc11
6330475801
100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (63304-758-01)
ndc11
6330475803
10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (63304-758-03)
ndc11
6330475805
500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (63304-758-05)
ndc11
6330475850
50 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (63304-758-50)

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": "63304-758_4d15b836-54c7-2f40-e063-6294a90a68a2",
  "productndc": "63304-758",
  "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"
}

Related drugs

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