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United States · US · US:0054-3188_d1ff8e50-faf9-4475-9fa0-314a620f8869
Diazepam
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
- ndc110054318863500 mL in 1 BOTTLE, PLASTIC (0054-3188-63)
Annotations
UNII (FDA Substance ID)
Q3JTX2Q7TU
DIAZEPAM
RxCUI 3322
Orange Book
A070928
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": "0054-3188_d1ff8e50-faf9-4475-9fa0-314a620f8869",
"productndc": "0054-3188",
"dosage_form": "SOLUTION",
"orange_book": {
"appl_no": "070928",
"products": [
{
"rs": true,
"rld": false,
"te_code": "AA",
"strength": "5MG/5ML",
"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",
"active_ingred_unit": "mg/5mL",
"application_number": "ANDA070928",
"marketing_category": "ANDA",
"nonproprietary_name": "Diazepam",
"start_marketing_date": "19870403",
"active_numerator_strength": "5"
}Related drugs
Other records sharing ATC code N05BA01.
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