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United States · US · US:58151-506_7ceb0a8d-f766-4806-a289-652080edf4a3
Xanax
Orange BookUNIISPLATC N05BA12
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerViatris Specialty LLC
CountryUS (United States)
ATC codeN05BA12
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11581515069160 TABLET, EXTENDED RELEASE in 1 BOTTLE (58151-506-91)
Annotations
UNII (FDA Substance ID)
YU55MQ3IZY
ALPRAZOLAM
RxCUI 596
Orange Book
N021434
ABABABAB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "YU55MQ3IZY",
"rxcui": "596",
"inchikey": "VREFGVBLTWBCJP-UHFFFAOYSA-N",
"display_name": "ALPRAZOLAM",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"388e249d-b9b6-44c3-9f8f-880eced0239f": {
"match": "brand_token",
"title": "XANAX (ALPRAZOLAM) TABLET [PHARMACIA & UPJOHN COMPANY LLC]",
"spl_version": "30",
"published_date": "2026-02-26"
}
},
"productid": "58151-506_7ceb0a8d-f766-4806-a289-652080edf4a3",
"productndc": "58151-506",
"dosage_form": "TABLET, EXTENDED RELEASE",
"orange_book": {
"appl_no": "021434",
"products": [
{
"rs": false,
"rld": true,
"te_code": "AB",
"strength": "0.5MG",
"product_no": "001",
"approval_date": "Jan 17, 2003"
},
{
"rs": false,
"rld": true,
"te_code": "AB",
"strength": "1MG",
"product_no": "002",
"approval_date": "Jan 17, 2003"
},
{
"rs": false,
"rld": true,
"te_code": "AB",
"strength": "2MG",
"product_no": "003",
"approval_date": "Jan 17, 2003"
},
{
"rs": true,
"rld": true,
"te_code": "AB",
"strength": "3MG",
"product_no": "004",
"approval_date": "Jan 17, 2003"
}
],
"appl_type": "N"
},
"dea_schedule": "CIV",
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "ALPRAZOLAM",
"proprietary_name": "Xanax",
"active_ingred_unit": "mg/1",
"application_number": "NDA021434",
"marketing_category": "NDA",
"nonproprietary_name": "alprazolam",
"start_marketing_date": "20240726",
"active_numerator_strength": "3"
}Related drugs
Other records sharing ATC code N05BA12.
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