🇺🇸
United States · US · US:11534-202_e95b8ea6-9d51-4621-bb87-a365121b08bb
DIAZEPAM
Orange BookUNIISPLATC N05BA01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerSunrise Pharmaceutical, Inc.
CountryUS (United States)
ATC codeN05BA01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc111153420201100 TABLET in 1 BOTTLE (11534-202-01)
- ndc1111534202031000 TABLET in 1 BOTTLE (11534-202-03)
- ndc111153420204500 TABLET in 1 BOTTLE (11534-202-04)
Annotations
UNII (FDA Substance ID)
Q3JTX2Q7TU
DIAZEPAM
RxCUI 3322
Orange Book
A070464
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": "11534-202_e95b8ea6-9d51-4621-bb87-a365121b08bb",
"productndc": "11534-202",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "070464",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "10MG",
"product_no": "001",
"approval_date": "Feb 25, 1986"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "2MG",
"product_no": "002",
"approval_date": "Sep 10, 2024"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "5MG",
"product_no": "003",
"approval_date": "Sep 10, 2024"
}
],
"appl_type": "A"
},
"dea_schedule": "CIV",
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "DIAZEPAM",
"proprietary_name": "DIAZEPAM",
"active_ingred_unit": "mg/1",
"application_number": "ANDA070464",
"marketing_category": "ANDA",
"nonproprietary_name": "diazepam",
"start_marketing_date": "20241209",
"active_numerator_strength": "2"
}Related drugs
Other records sharing ATC code N05BA01.
Access this data programmatically
Query DIAZEPAM and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.