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United States · US · US:68682-655_0e23d654-d8b9-af1c-e063-6294a90a6f14
Diazepam
Orange BookUNIISPLATC N05BA01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerOceanside Pharmaceuticals
CountryUS (United States)
ATC codeN05BA01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1168682655202 SYRINGE, PLASTIC in 1 PACKAGE (68682-655-20) / 4 mL in 1 SYRINGE, PLASTIC
Annotations
UNII (FDA Substance ID)
Q3JTX2Q7TU
DIAZEPAM
RxCUI 3322
Orange Book
N020648
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": "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": "68682-655_0e23d654-d8b9-af1c-e063-6294a90a6f14",
"productndc": "68682-655",
"dosage_form": "GEL",
"orange_book": {
"appl_no": "020648",
"products": [
{
"rs": true,
"rld": true,
"te_code": "AB",
"strength": "2.5MG/0.5ML (5MG/ML)",
"product_no": "001",
"approval_date": "Jul 29, 1997"
},
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "5MG/ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",
"product_no": "002",
"approval_date": "Jul 29, 1997"
},
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "10MG/2ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",
"product_no": "003",
"approval_date": "Jul 29, 1997"
},
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "15MG/3ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",
"product_no": "004",
"approval_date": "Jul 29, 1997"
},
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "20MG/4ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",
"product_no": "005",
"approval_date": "Jul 29, 1997"
},
{
"rs": true,
"rld": true,
"te_code": "AB",
"strength": "20MG/4ML (5MG/ML)",
"product_no": "006",
"approval_date": "Sep 15, 2005"
},
{
"rs": true,
"rld": true,
"te_code": "AB",
"strength": "10MG/2ML (5MG/ML)",
"product_no": "007",
"approval_date": "Sep 15, 2005"
}
],
"appl_type": "N"
},
"dea_schedule": "CIV",
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "DIAZEPAM",
"proprietary_name": "Diazepam",
"active_ingred_unit": "mg/4mL",
"application_number": "NDA020648",
"marketing_category": "NDA AUTHORIZED GENERIC",
"nonproprietary_name": "Diazepam",
"start_marketing_date": "19970729",
"active_numerator_strength": "20"
}Related drugs
Other records sharing ATC code N05BA01.
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