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United States · US · US:63187-521_001c902a-af30-40fb-bb22-cc18bd8fc94c

bupropion

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
    6318752130
    30 TABLET, EXTENDED RELEASE in 1 BOTTLE (63187-521-30)
  • ndc11
    6318752160
    60 TABLET, EXTENDED RELEASE in 1 BOTTLE (63187-521-60)
  • ndc11
    6318752190
    90 TABLET, EXTENDED RELEASE in 1 BOTTLE (63187-521-90)

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": "63187-521_001c902a-af30-40fb-bb22-cc18bd8fc94c",
  "productndc": "63187-521",
  "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": "20140215",
  "active_numerator_strength": "300"
}

Related drugs

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