Morphine Sulfate

In shortageOrange BookUNIISPLATC N02AA51

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

Identification

ManufacturerWinder Laboratories LLC

CountryUS (United States)

ATC codeN02AA51

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 2

ndc11
7582612905
100 mL in 1 BOTTLE, PLASTIC (75826-129-05)
ndc11
7582612917
500 mL in 1 BOTTLE, PLASTIC (75826-129-17)

Annotations

UNII (FDA Substance ID)

X3P646A2J0

MORPHINE SULFATE

RxCUI 30236

Orange Book

A211454

AAAAAA

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": "75826-129_2b0eba4c-7f43-72ef-e063-6294a90afd7e",
  "productndc": "75826-129",
  "dosage_form": "SOLUTION",
  "orange_book": {
    "appl_no": "211454",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AA",
        "strength": "10MG/5ML",
        "product_no": "001",
        "approval_date": "Feb 12, 2021"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AA",
        "strength": "20MG/5ML",
        "product_no": "002",
        "approval_date": "Feb 12, 2021"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AA",
        "strength": "100MG/5ML",
        "product_no": "003",
        "approval_date": "Feb 12, 2021"
      }
    ],
    "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/5mL",
  "application_number": "ANDA211454",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Morphine Sulfate",
  "start_marketing_date": "20190515",
  "active_numerator_strength": "10"
}

Related drugs

Other records sharing ATC code N02AA51.

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