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United States · US · US:0140-0004_ea505cdb-6d89-4b8c-8007-ec5a5fe920ce
Valium
Orange BookUNIISPLATC N05BA01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerRoche Laboratories Inc.
CountryUS (United States)
ATC codeN05BA01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1101400004011 BOTTLE, PLASTIC in 1 CARTON (0140-0004-01) / 100 TABLET in 1 BOTTLE, PLASTIC
Annotations
UNII (FDA Substance ID)
Q3JTX2Q7TU
DIAZEPAM
RxCUI 3322
Orange Book
N013263
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": {
"554baee5-b171-4452-a50a-41a0946f956c": {
"match": "brand_token",
"title": "VALIUM (DIAZEPAM) TABLET [ROCHE LABORATORIES INC.]",
"spl_version": "21",
"published_date": "2025-12-10"
}
},
"productid": "0140-0004_ea505cdb-6d89-4b8c-8007-ec5a5fe920ce",
"productndc": "0140-0004",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "013263",
"products": [
{
"rs": false,
"rld": true,
"te_code": "AB",
"strength": "2MG",
"product_no": "002",
"approval_date": "Approved Prior to Jan 1, 1982"
},
{
"rs": false,
"rld": true,
"te_code": "AB",
"strength": "5MG",
"product_no": "004",
"approval_date": "Approved Prior to Jan 1, 1982"
},
{
"rs": true,
"rld": true,
"te_code": "AB",
"strength": "10MG",
"product_no": "006",
"approval_date": "Approved Prior to Jan 1, 1982"
}
],
"appl_type": "N"
},
"dea_schedule": "CIV",
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "DIAZEPAM",
"proprietary_name": "Valium",
"active_ingred_unit": "mg/1",
"application_number": "NDA013263",
"marketing_category": "NDA",
"nonproprietary_name": "diazepam",
"start_marketing_date": "19631115",
"active_numerator_strength": "2"
}Related drugs
Other records sharing ATC code N05BA01.
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