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United States · US · US:0054-3566_fba22894-bfd7-4332-9d8b-34fc48389520
Midazolam Hydrochloride
In shortageOrange BookUNIISPLATC N05CD08
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerHikma Pharmaceuticals USA Inc.
CountryUS (United States)
ATC codeN05CD08
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc110054356699118 mL in 1 BOTTLE, GLASS (0054-3566-99)
Annotations
UNII (FDA Substance ID)
W7TTW573JJ
MIDAZOLAM HYDROCHLORIDE
RxCUI 203128
Orange Book
A075873
AA
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Midazolam Hydrochloride Injection
Raw payload (JSON)
{
"unii": {
"unii": "W7TTW573JJ",
"rxcui": "203128",
"inchikey": "PLYSCVSCYOQVRP-UHFFFAOYSA-N",
"display_name": "MIDAZOLAM HYDROCHLORIDE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"8b690f5c-2923-4c34-a8f7-11af5f546b62": {
"match": "brand_token",
"title": "MIDAZOLAM HYDROCHLORIDE INJECTION, SOLUTION [HERITAGE PHARMACEUTICALS INC. D/B/A AVET PHARMACEUTICALS INC.]",
"spl_version": "13",
"published_date": "2026-05-28"
}
},
"productid": "0054-3566_fba22894-bfd7-4332-9d8b-34fc48389520",
"productndc": "0054-3566",
"dosage_form": "SYRUP",
"orange_book": {
"appl_no": "075873",
"products": [
{
"rs": true,
"rld": false,
"te_code": "AA",
"strength": "EQ 2MG BASE/ML",
"product_no": "001",
"approval_date": "Apr 30, 2002"
}
],
"appl_type": "A"
},
"dea_schedule": "CIV",
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "MIDAZOLAM HYDROCHLORIDE",
"shortage_reason": "Midazolam Hydrochloride Injection",
"shortage_status": "current",
"proprietary_name": "Midazolam Hydrochloride",
"active_ingred_unit": "mg/mL",
"application_number": "ANDA075873",
"marketing_category": "ANDA",
"nonproprietary_name": "Midazolam Hydrochloride",
"start_marketing_date": "20020430",
"active_numerator_strength": "2"
}Related drugs
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