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United States · US · US:0409-2022_6f2d5741-5543-4bea-8d1d-7e4889b634a0
Morphine sulfate
In shortageOrange BookUNIISPLATC N02AA51
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerHospira, Inc.
CountryUS (United States)
ATC codeN02AA51
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1104092022011 VIAL, SINGLE-DOSE in 1 CARTON (0409-2022-01) / 50 mL in 1 VIAL, SINGLE-DOSE
Annotations
UNII (FDA Substance ID)
X3P646A2J0
MORPHINE SULFATE
RxCUI 30236
Orange Book
N202515
APAPAPAP
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": "INTRAVENOUS",
"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": "0409-2022_6f2d5741-5543-4bea-8d1d-7e4889b634a0",
"productndc": "0409-2022",
"dosage_form": "INJECTION, SOLUTION",
"orange_book": {
"appl_no": "202515",
"products": [
{
"rs": true,
"rld": true,
"te_code": "AP",
"strength": "2MG/ML",
"product_no": "001",
"approval_date": "Nov 14, 2011"
},
{
"rs": false,
"rld": true,
"te_code": "AP",
"strength": "4MG/ML",
"product_no": "002",
"approval_date": "Nov 14, 2011"
},
{
"rs": false,
"rld": true,
"te_code": "AP",
"strength": "8MG/ML",
"product_no": "003",
"approval_date": "Nov 14, 2011"
},
{
"rs": false,
"rld": true,
"te_code": "AP",
"strength": "10MG/ML",
"product_no": "004",
"approval_date": "Nov 14, 2011"
},
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "15MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",
"product_no": "005",
"approval_date": "Nov 14, 2011"
},
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "50MG/ML",
"product_no": "006",
"approval_date": "Apr 29, 2021"
}
],
"appl_type": "N"
},
"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": "NDA202515",
"marketing_category": "NDA",
"nonproprietary_name": "Morphine Sulfate",
"start_marketing_date": "20250421",
"active_numerator_strength": "50"
}Related drugs
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