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United States · US · US:71872-7030_fd163116-8854-9366-e053-6394a90a00b5
Dexmedetomidine hydrochloride
In shortageOrange BookUNIISPLATC N05CM18
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerMedical Purchasing Solutions, LLC
CountryUS (United States)
ATC codeN05CM18
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1171872703011 VIAL in 1 BAG (71872-7030-1) / 2 mL in 1 VIAL
Annotations
UNII (FDA Substance ID)
1018WH7F9I
DEXMEDETOMIDINE HYDROCHLORIDE
RxCUI 228054
Orange Book
A204023
AP
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Dexmedetomidine Hydrochloride Injection
Raw payload (JSON)
{
"unii": {
"unii": "1018WH7F9I",
"rxcui": "228054",
"inchikey": "VPNGEIHDPSLNMU-MERQFXBCSA-N",
"display_name": "DEXMEDETOMIDINE HYDROCHLORIDE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "INTRAVENOUS",
"spl_meta": {
"f140de5a-f13d-46b4-a742-049c63e474f5": {
"match": "brand_token",
"title": "DEXMEDETOMIDINE HYDROCHLORIDE INJECTION, SOLUTION [MYLAN INSTITUTIONAL LLC]",
"spl_version": "4",
"published_date": "2026-05-29"
}
},
"productid": "71872-7030_fd163116-8854-9366-e053-6394a90a00b5",
"productndc": "71872-7030",
"dosage_form": "INJECTION, SOLUTION",
"orange_book": {
"appl_no": "204023",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AP",
"strength": "EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)",
"product_no": "001",
"approval_date": "Feb 9, 2016"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "DEXMEDETOMIDINE HYDROCHLORIDE",
"shortage_reason": "Dexmedetomidine Hydrochloride Injection",
"shortage_status": "current",
"proprietary_name": "Dexmedetomidine hydrochloride",
"active_ingred_unit": "ug/mL",
"application_number": "ANDA204023",
"marketing_category": "ANDA",
"nonproprietary_name": "Dexmedetomidine hydrochloride",
"start_marketing_date": "20161221",
"active_numerator_strength": "100"
}Related drugs
Other records sharing ATC code N05CM18.
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