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United States · US · US:69680-158_c7d45984-a653-4be6-9b1c-986a553e4e42
Bupropion hydrochloride (XL)
Orange BookUNIISPLATC N06AX12
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerVitruvias Therapeutics
CountryUS (United States)
ATC codeN06AX12
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 4
- ndc11696801583030 TABLET, EXTENDED RELEASE in 1 BOTTLE (69680-158-30)
- ndc11696801589090 TABLET, EXTENDED RELEASE in 1 BOTTLE (69680-158-90)
- ndc116968015892500 TABLET, EXTENDED RELEASE in 1 BOTTLE (69680-158-92)
- ndc1169680158931000 TABLET, EXTENDED RELEASE in 1 BOTTLE (69680-158-93)
Annotations
UNII (FDA Substance ID)
ZG7E5POY8O
BUPROPION HYDROCHLORIDE
RxCUI 203204
Orange Book
A208652
AB3AB3
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "ZG7E5POY8O",
"rxcui": "203204",
"inchikey": "HEYVINCGKDONRU-UHFFFAOYSA-N",
"display_name": "BUPROPION HYDROCHLORIDE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"cefaaa17-f79a-4ba6-8f97-a59f60e07b75": {
"match": "brand_token",
"title": "BUPROPION HYDROCHLORIDE (XL) (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [BRYANT RANCH PREPACK]",
"spl_version": "105",
"published_date": "2026-06-01"
}
},
"productid": "69680-158_c7d45984-a653-4be6-9b1c-986a553e4e42",
"productndc": "69680-158",
"dosage_form": "TABLET, EXTENDED RELEASE",
"orange_book": {
"appl_no": "208652",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB3",
"strength": "150MG",
"product_no": "001",
"approval_date": "Aug 21, 2017"
},
{
"rs": false,
"rld": false,
"te_code": "AB3",
"strength": "300MG",
"product_no": "002",
"approval_date": "Aug 21, 2017"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "BUPROPION HYDROCHLORIDE",
"proprietary_name": "Bupropion hydrochloride (XL)",
"active_ingred_unit": "mg/1",
"application_number": "ANDA208652",
"marketing_category": "ANDA",
"nonproprietary_name": "Bupropion hydrochloride",
"start_marketing_date": "20230410",
"active_numerator_strength": "300"
}Related drugs
Other records sharing ATC code N06AX12.
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