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United States · US · US:0054-3185_ab533d6f-4e34-4675-9da6-b93484134aca
Diazepam Intensol
Orange BookUNIISPLATC N05BA01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerHikma Pharmaceuticals USA Inc.
CountryUS (United States)
ATC codeN05BA01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1100543185441 BOTTLE in 1 CARTON (0054-3185-44) / 30 mL in 1 BOTTLE
Annotations
UNII (FDA Substance ID)
Q3JTX2Q7TU
DIAZEPAM
RxCUI 3322
Orange Book
A071415
AA
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "Q3JTX2Q7TU",
"rxcui": "3322",
"inchikey": "AAOVKJBEBIDNHE-UHFFFAOYSA-N",
"display_name": "DIAZEPAM",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"7e7dd743-a87b-4ab3-b6ae-f116cd0c8b0f": {
"match": "brand_token",
"title": "DIAZEPAM INJECTION, SOLUTION [HOSPIRA, INC.]",
"spl_version": "26",
"published_date": "2026-05-25"
}
},
"productid": "0054-3185_ab533d6f-4e34-4675-9da6-b93484134aca",
"productndc": "0054-3185",
"dosage_form": "SOLUTION, CONCENTRATE",
"orange_book": {
"appl_no": "071415",
"products": [
{
"rs": true,
"rld": false,
"te_code": "AA",
"strength": "5MG/ML",
"product_no": "001",
"approval_date": "Apr 3, 1987"
}
],
"appl_type": "A"
},
"dea_schedule": "CIV",
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "DIAZEPAM",
"proprietary_name": "Diazepam Intensol",
"active_ingred_unit": "mg/mL",
"application_number": "ANDA071415",
"marketing_category": "ANDA",
"nonproprietary_name": "Diazepam Intensol",
"start_marketing_date": "19870403",
"active_numerator_strength": "5"
}Related drugs
Other records sharing ATC code N05BA01.
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