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United States · US · US:43386-281_91b10d2a-111a-4f2b-8b9a-d9c5d4a783f5
Diazepam
Orange BookUNIISPLATC N05BA01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerLupin Pharmaceuticals,Inc.
CountryUS (United States)
ATC codeN05BA01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1143386281021 PACKAGE in 1 CARTON (43386-281-02) / 2 SYRINGE in 1 PACKAGE (43386-281-01) / 4 g in 1 SYRINGE (43386-281-03)
Annotations
UNII (FDA Substance ID)
Q3JTX2Q7TU
DIAZEPAM
RxCUI 3322
Orange Book
A091076
ABAB
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": "RECTAL",
"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": "43386-281_91b10d2a-111a-4f2b-8b9a-d9c5d4a783f5",
"productndc": "43386-281",
"dosage_form": "GEL",
"orange_book": {
"appl_no": "091076",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "10MG/2ML (5MG/ML)",
"product_no": "001",
"approval_date": "May 30, 2023"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "20MG/4ML (5MG/ML)",
"product_no": "002",
"approval_date": "May 30, 2023"
}
],
"appl_type": "A"
},
"dea_schedule": "CIV",
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "DIAZEPAM",
"proprietary_name": "Diazepam",
"active_ingred_unit": "mg/4g",
"application_number": "ANDA091076",
"marketing_category": "ANDA",
"nonproprietary_name": "Diazepam",
"start_marketing_date": "20231030",
"active_numerator_strength": "20"
}Related drugs
Other records sharing ATC code N05BA01.
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