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United States · US · US:68083-108_3b7a93cb-a43a-46d0-ad52-6fba91da232d
Midazolam Hydrochloride
In shortageOrange BookUNIISPLATC N05CD08
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerGland Pharma Limited
CountryUS (United States)
ATC codeN05CD08
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc11680831080110 VIAL, MULTI-DOSE in 1 CARTON (68083-108-01) / 5 mL in 1 VIAL, MULTI-DOSE
- ndc11680831080210 VIAL, MULTI-DOSE in 1 CARTON (68083-108-02) / 10 mL in 1 VIAL, MULTI-DOSE
Annotations
UNII (FDA Substance ID)
W7TTW573JJ
MIDAZOLAM HYDROCHLORIDE
RxCUI 203128
Orange Book
A090850
AP
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": "INTRAMUSCULAR; INTRAVENOUS",
"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": "68083-108_3b7a93cb-a43a-46d0-ad52-6fba91da232d",
"productndc": "68083-108",
"dosage_form": "INJECTION, SOLUTION",
"orange_book": {
"appl_no": "090850",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AP",
"strength": "EQ 5MG BASE/ML",
"product_no": "001",
"approval_date": "Jan 25, 2012"
}
],
"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": "ANDA090850",
"marketing_category": "ANDA",
"nonproprietary_name": "Midazolam Hydrochloride",
"start_marketing_date": "20120601",
"active_numerator_strength": "5"
}Related drugs
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- ISBuccolamNeuraxpharm Pharmaceuticals S.L.
- ISBuccolamNeuraxpharm Pharmaceuticals S.L.
- ISBuccolamNeuraxpharm Pharmaceuticals S.L.
- DKBuccolamNeuraxpharm Pharmaceuticals S.L.
- ISBuccolamNeuraxpharm Pharmaceuticals S.L.
- DKBuccolamNeuraxpharm Pharmaceuticals S.L.
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