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United States · US · US:65162-812_4b2e21bc-ca1c-4ff5-a996-32f1e94d2a91
Alprazolam
Orange BookUNIISPLATC N05BA12
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAmneal Pharmaceuticals LLC
CountryUS (United States)
ATC codeN05BA12
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc11651628120330 TABLET, EXTENDED RELEASE in 1 BOTTLE (65162-812-03)
- ndc11651628120660 TABLET, EXTENDED RELEASE in 1 BOTTLE (65162-812-06)
- ndc116516281250500 TABLET, EXTENDED RELEASE in 1 BOTTLE (65162-812-50)
Annotations
UNII (FDA Substance ID)
YU55MQ3IZY
ALPRAZOLAM
RxCUI 596
Orange Book
A078387
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": {
"68d8b8d1-00a4-42c4-a796-90211fee1a6d": {
"match": "brand_token",
"title": "ALPRAZOLAM TABLET [BRYANT RANCH PREPACK]",
"spl_version": "104",
"published_date": "2026-05-22"
}
},
"productid": "65162-812_4b2e21bc-ca1c-4ff5-a996-32f1e94d2a91",
"productndc": "65162-812",
"dosage_form": "TABLET, EXTENDED RELEASE",
"orange_book": {
"appl_no": "078387",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "0.5MG",
"product_no": "001",
"approval_date": "May 30, 2008"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "1MG",
"product_no": "002",
"approval_date": "May 30, 2008"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "2MG",
"product_no": "003",
"approval_date": "May 30, 2008"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "3MG",
"product_no": "004",
"approval_date": "May 30, 2008"
}
],
"appl_type": "A"
},
"dea_schedule": "CIV",
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "ALPRAZOLAM",
"proprietary_name": "Alprazolam",
"active_ingred_unit": "mg/1",
"application_number": "ANDA078387",
"marketing_category": "ANDA",
"nonproprietary_name": "Alprazolam",
"start_marketing_date": "20091203",
"active_numerator_strength": "2"
}Related drugs
Other records sharing ATC code N05BA12.
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