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United States · US · US:45963-142_50d33e34-1a33-4595-b06a-4da2f7d7d518

Bupropion Hydrochloride

Orange BookUNIISPLATC N06AX12

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

Identification

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

Packs · 3

  • ndc11
    4596314205
    500 TABLET, EXTENDED RELEASE in 1 BOTTLE (45963-142-05)
  • ndc11
    4596314230
    30 TABLET, EXTENDED RELEASE in 1 BOTTLE (45963-142-30)
  • ndc11
    4596314290
    90 TABLET, EXTENDED RELEASE in 1 BOTTLE (45963-142-90)

Annotations

UNII (FDA Substance ID)
ZG7E5POY8O
BUPROPION HYDROCHLORIDE
RxCUI 203204
Orange Book
A077285
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": "45963-142_50d33e34-1a33-4595-b06a-4da2f7d7d518",
  "productndc": "45963-142",
  "dosage_form": "TABLET, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "077285",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB3",
        "strength": "150MG",
        "product_no": "001",
        "approval_date": "Nov 26, 2008"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB3",
        "strength": "300MG",
        "product_no": "002",
        "approval_date": "Aug 15, 2008"
      }
    ],
    "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": "ANDA077285",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Bupropion Hydrochloride",
  "start_marketing_date": "20150217",
  "active_numerator_strength": "300"
}

Related drugs

Other records sharing ATC code N06AX12.

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