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United States · US · US:0615-8505_31890576-e68d-4449-b0dd-205175720f6b
Bupropion Hydrochloride
Orange BookUNIISPLATC N06AX12
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerNCS HealthCare of KY, LLC dba Vangard Labs
CountryUS (United States)
ATC codeN06AX12
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc11061585050515 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (0615-8505-05)
- ndc11061585053930 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (0615-8505-39)
Annotations
UNII (FDA Substance ID)
ZG7E5POY8O
BUPROPION HYDROCHLORIDE
RxCUI 203204
Orange Book
A211020
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": "0615-8505_31890576-e68d-4449-b0dd-205175720f6b",
"productndc": "0615-8505",
"dosage_form": "TABLET, EXTENDED RELEASE",
"orange_book": {
"appl_no": "211020",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB3",
"strength": "150MG",
"product_no": "001",
"approval_date": "Jan 28, 2019"
},
{
"rs": false,
"rld": false,
"te_code": "AB3",
"strength": "300MG",
"product_no": "002",
"approval_date": "Jan 28, 2019"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "BUPROPION HYDROCHLORIDE",
"proprietary_name": "Bupropion Hydrochloride",
"active_ingred_unit": "mg/1",
"application_number": "ANDA211020",
"marketing_category": "ANDA",
"nonproprietary_name": "Bupropion Hydrochloride",
"start_marketing_date": "20220801",
"active_numerator_strength": "300"
}Related drugs
Other records sharing ATC code N06AX12.
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