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United States · US · US:66794-162_495a6a51-d35d-2b96-e063-6394a90ac5f3

MITIGO

In shortageOrange BookUNIISPLATC N02AA51

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

Identification

ManufacturerPiramal Critical Care, Inc.
CountryUS (United States)
ATC codeN02AA51
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    6679416202
    1 mL in 1 VIAL, SINGLE-USE (66794-162-02)

Annotations

UNII (FDA Substance ID)
X3P646A2J0
MORPHINE SULFATE
RxCUI 30236
Orange Book
A204393
APAP
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": "EPIDURAL; INTRATHECAL",
  "spl_meta": {
    "728f3d83-9a63-0c1f-e053-2a91aa0ac7db": {
      "match": "brand_token",
      "title": "MITIGO (MORPHINE SULFATE) INJECTION [PIRAMAL CRITICAL CARE, INC.]",
      "spl_version": "19",
      "published_date": "2026-02-24"
    }
  },
  "productid": "66794-162_495a6a51-d35d-2b96-e063-6394a90ac5f3",
  "productndc": "66794-162",
  "dosage_form": "INJECTION",
  "orange_book": {
    "appl_no": "204393",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "10MG/ML",
        "product_no": "001",
        "approval_date": "Jul 16, 2018"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "25MG/ML",
        "product_no": "002",
        "approval_date": "Jul 16, 2018"
      }
    ],
    "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": "MITIGO",
  "active_ingred_unit": "mg/20mL",
  "application_number": "ANDA204393",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Morphine Sulfate",
  "start_marketing_date": "20181015",
  "active_numerator_strength": "500"
}

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