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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
- ndc1166794162021 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"
}Related drugs
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