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United States · US · US:82804-080_dfd5f264-d4fd-4441-88b1-48086c7c0616

Bupropion Hydrochloride

Orange BookUNIISPLATC N06AX12

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerProficient Rx LP
CountryUS (United States)
ATC codeN06AX12
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 3

  • ndc11
    8280408030
    30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (82804-080-30)
  • ndc11
    8280408060
    60 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (82804-080-60)
  • ndc11
    8280408090
    90 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (82804-080-90)

Annotations

UNII (FDA Substance ID)
ZG7E5POY8O
BUPROPION HYDROCHLORIDE
RxCUI 203204
Orange Book
A210015
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": "82804-080_dfd5f264-d4fd-4441-88b1-48086c7c0616",
  "productndc": "82804-080",
  "dosage_form": "TABLET, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "210015",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB3",
        "strength": "150MG",
        "product_no": "001",
        "approval_date": "Jun 14, 2018"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB3",
        "strength": "300MG",
        "product_no": "002",
        "approval_date": "Jun 14, 2018"
      }
    ],
    "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": "ANDA210015",
  "marketing_category": "ANDA",
  "nonproprietary_name": "bupropion hydrochloride",
  "start_marketing_date": "20230430",
  "active_numerator_strength": "150"
}

Related drugs

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