MORPHINE SULFATE

In shortageOrange BookUNIISPLATC N02AA51

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

Identification

ManufacturerSpecGx LLC

CountryUS (United States)

ATC codeN02AA51

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 3

ndc11
0406838001
100 TABLET, EXTENDED RELEASE in 1 BOTTLE (0406-8380-01)
ndc11
0406838023
1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (0406-8380-23)
ndc11
0406838062
100 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (0406-8380-62)

Annotations

UNII (FDA Substance ID)

X3P646A2J0

MORPHINE SULFATE

RxCUI 30236

Orange Book

A076412

ABABAB

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": "0406-8380_6873cac9-e7d5-4db2-851d-528268b483e9",
  "productndc": "0406-8380",
  "dosage_form": "TABLET, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "076412",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "15MG",
        "product_no": "001",
        "approval_date": "Jul 31, 2003"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "30MG",
        "product_no": "002",
        "approval_date": "Jul 31, 2003"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "60MG",
        "product_no": "003",
        "approval_date": "Jul 31, 2003"
      }
    ],
    "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": "ANDA076412",
  "marketing_category": "ANDA",
  "nonproprietary_name": "MORPHINE SULFATE",
  "start_marketing_date": "20030731",
  "active_numerator_strength": "60"
}

Related drugs

Other records sharing ATC code N02AA51.

Access this data programmatically

Query MORPHINE SULFATE and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.

Get a free API key Read the API docs