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 · 4

ndc11
0406800312
6 CARTON in 1 CASE (0406-8003-12) / 1 BOTTLE, PLASTIC in 1 CARTON / 120 mL in 1 BOTTLE, PLASTIC
ndc11
0406800315
6 CARTON in 1 CASE (0406-8003-15) / 1 BOTTLE, PLASTIC in 1 CARTON / 15 mL in 1 BOTTLE, PLASTIC
ndc11
0406800324
6 CARTON in 1 CASE (0406-8003-24) / 1 BOTTLE, PLASTIC in 1 CARTON / 240 mL in 1 BOTTLE, PLASTIC
ndc11
0406800330
6 CARTON in 1 CASE (0406-8003-30) / 1 BOTTLE, PLASTIC in 1 CARTON / 30 mL in 1 BOTTLE, PLASTIC

Annotations

UNII (FDA Substance ID)

X3P646A2J0

MORPHINE SULFATE

RxCUI 30236

Orange Book

A202348

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": "0406-8003_852596c9-601f-477c-9966-580f728d9e54",
  "productndc": "0406-8003",
  "dosage_form": "SOLUTION",
  "orange_book": {
    "appl_no": "202348",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AA",
        "strength": "100MG/5ML",
        "product_no": "001",
        "approval_date": "Jul 15, 2011"
      }
    ],
    "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/mL",
  "application_number": "ANDA202348",
  "marketing_category": "ANDA",
  "nonproprietary_name": "morphine sulfate",
  "start_marketing_date": "20110715",
  "active_numerator_strength": "20"
}

Related drugs

Other records sharing ATC code N02AA51.

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