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United States · US · US:0378-0271_983a3fdc-04ca-4621-a57c-56ad36015d36
Diazepam
Orange BookUNIISPLATC N05BA01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerMylan Pharmaceuticals Inc.
CountryUS (United States)
ATC codeN05BA01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc110378027101100 TABLET in 1 BOTTLE, PLASTIC (0378-0271-01)
- ndc110378027105500 TABLET in 1 BOTTLE, PLASTIC (0378-0271-05)
Annotations
UNII (FDA Substance ID)
Q3JTX2Q7TU
DIAZEPAM
RxCUI 3322
Orange Book
A070325
ABABAB
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": "0378-0271_983a3fdc-04ca-4621-a57c-56ad36015d36",
"productndc": "0378-0271",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "070325",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "10MG",
"product_no": "001",
"approval_date": "Sep 4, 1985"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "2MG",
"product_no": "002",
"approval_date": "Sep 4, 1985"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "5MG",
"product_no": "003",
"approval_date": "Sep 4, 1985"
}
],
"appl_type": "A"
},
"dea_schedule": "CIV",
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "DIAZEPAM",
"proprietary_name": "Diazepam",
"active_ingred_unit": "mg/1",
"application_number": "ANDA070325",
"marketing_category": "ANDA",
"nonproprietary_name": "diazepam",
"start_marketing_date": "19850904",
"active_numerator_strength": "2"
}Related drugs
Other records sharing ATC code N05BA01.
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