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United States · US · US:0187-5810_45372e42-065d-4d87-89af-d5dcf09c29fb
Aplenzin
Orange BookUNIISPLATC N06AX12
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerBausch Health US, LLC
CountryUS (United States)
ATC codeN06AX12
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc1101875810077 TABLET, EXTENDED RELEASE in 1 BOTTLE (0187-5810-07)
- ndc11018758103030 TABLET, EXTENDED RELEASE in 1 BOTTLE (0187-5810-30)
Annotations
UNII (FDA Substance ID)
E70G3G5863
BUPROPION HYDROBROMIDE
RxCUI 993548
Orange Book
N022108
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "E70G3G5863",
"rxcui": "993548",
"inchikey": "WSTCENNATOVXKQ-UHFFFAOYSA-N",
"display_name": "BUPROPION HYDROBROMIDE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"6494d2d9-0ce4-4126-b1c7-49684395942b": {
"match": "brand_token",
"title": "APLENZIN (BUPROPION HYDROBROMIDE) TABLET, EXTENDED RELEASE [BAUSCH HEALTH US, LLC]",
"spl_version": "27",
"published_date": "2026-03-05"
}
},
"productid": "0187-5810_45372e42-065d-4d87-89af-d5dcf09c29fb",
"productndc": "0187-5810",
"dosage_form": "TABLET, EXTENDED RELEASE",
"orange_book": {
"appl_no": "022108",
"products": [
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "174MG",
"product_no": "001",
"approval_date": "Apr 23, 2008"
},
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "348MG",
"product_no": "002",
"approval_date": "Apr 23, 2008"
},
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "522MG",
"product_no": "003",
"approval_date": "Apr 23, 2008"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "BUPROPION HYDROBROMIDE",
"proprietary_name": "Aplenzin",
"active_ingred_unit": "mg/1",
"application_number": "NDA022108",
"marketing_category": "NDA",
"nonproprietary_name": "bupropion hydrobromide",
"start_marketing_date": "20080423",
"active_numerator_strength": "174"
}Related drugs
Other records sharing ATC code N06AX12.
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