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United States · US · US:68382-353_00be046c-e051-4430-a967-3a0d4611da22
bupropion
Orange BookUNIISPLATC N06AX12
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerZydus Pharmaceuticals USA Inc.
CountryUS (United States)
ATC codeN06AX12
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 4
- ndc116838235305500 TABLET, EXTENDED RELEASE in 1 BOTTLE (68382-353-05)
- ndc11683823530630 TABLET, EXTENDED RELEASE in 1 BOTTLE (68382-353-06)
- ndc1168382353101000 TABLET, EXTENDED RELEASE in 1 BOTTLE (68382-353-10)
- ndc11683823531690 TABLET, EXTENDED RELEASE in 1 BOTTLE (68382-353-16)
Annotations
UNII (FDA Substance ID)
ZG7E5POY8O
BUPROPION HYDROCHLORIDE
RxCUI 203204
Orange Book
A201567
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": "68382-353_00be046c-e051-4430-a967-3a0d4611da22",
"productndc": "68382-353",
"dosage_form": "TABLET, EXTENDED RELEASE",
"orange_book": {
"appl_no": "201567",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB3",
"strength": "300MG",
"product_no": "001",
"approval_date": "Jan 17, 2014"
},
{
"rs": false,
"rld": false,
"te_code": "AB3",
"strength": "150MG",
"product_no": "002",
"approval_date": "Jul 23, 2018"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "BUPROPION HYDROCHLORIDE",
"proprietary_name": "bupropion",
"active_ingred_unit": "mg/1",
"application_number": "ANDA201567",
"marketing_category": "ANDA",
"nonproprietary_name": "bupropion",
"start_marketing_date": "20180802",
"active_numerator_strength": "150"
}Related drugs
Other records sharing ATC code N06AX12.
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