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United States · US · US:68788-7793_fe9c69c0-3a09-4dbe-b79f-f695468cbd1b

Bupropion Hydrochloride

Orange BookUNIISPLATC N06AX12

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

Identification

ManufacturerPreferred Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeN06AX12
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 6

  • ndc11
    6878877931
    100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (68788-7793-1)
  • ndc11
    6878877932
    20 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (68788-7793-2)
  • ndc11
    6878877933
    30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (68788-7793-3)
  • ndc11
    6878877936
    60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (68788-7793-6)
  • ndc11
    6878877938
    120 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (68788-7793-8)
  • ndc11
    6878877939
    90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (68788-7793-9)

Annotations

UNII (FDA Substance ID)
ZG7E5POY8O
BUPROPION HYDROCHLORIDE
RxCUI 203204
Orange Book
A205794
AB1AB1AB1
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": "68788-7793_fe9c69c0-3a09-4dbe-b79f-f695468cbd1b",
  "productndc": "68788-7793",
  "dosage_form": "TABLET, FILM COATED, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "205794",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB1",
        "strength": "100MG",
        "product_no": "001",
        "approval_date": "Mar 1, 2016"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB1",
        "strength": "150MG",
        "product_no": "002",
        "approval_date": "Mar 1, 2016"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB1",
        "strength": "200MG",
        "product_no": "003",
        "approval_date": "Mar 1, 2016"
      }
    ],
    "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": "ANDA205794",
  "marketing_category": "ANDA",
  "nonproprietary_name": "bupropion hydrochloride",
  "start_marketing_date": "20201013",
  "active_numerator_strength": "200"
}

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