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United States · US · US:0143-9532_8cb1c4c8-48b4-471f-b443-5f03896a3fb7
Dexmedetomidine HCl
In shortageOrange BookUNIISPLATC N05CM18
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerHikma Pharmaceuticals USA Inc.
CountryUS (United States)
ATC codeN05CM18
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11014395322525 VIAL in 1 CARTON (0143-9532-25) / 2 mL in 1 VIAL (0143-9532-01)
Annotations
UNII (FDA Substance ID)
1018WH7F9I
DEXMEDETOMIDINE HYDROCHLORIDE
RxCUI 228054
Orange Book
A205046
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": "0143-9532_8cb1c4c8-48b4-471f-b443-5f03896a3fb7",
"productndc": "0143-9532",
"dosage_form": "INJECTION",
"orange_book": {
"appl_no": "205046",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AP",
"strength": "EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)",
"product_no": "001",
"approval_date": "Apr 26, 2017"
}
],
"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 HCl",
"active_ingred_unit": "ug/mL",
"application_number": "ANDA205046",
"marketing_category": "ANDA",
"nonproprietary_name": "Dexmedetomidine HCl",
"start_marketing_date": "20170426",
"active_numerator_strength": "100"
}Related drugs
Other records sharing ATC code N05CM18.
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