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United States · US · US:65841-836_6c831525-a7c2-4ef1-b1b9-c7e8cb807ded

bupropion

Orange BookUNIISPLATC N06AX12

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

Identification

ManufacturerZydus Lifesciences Limited
CountryUS (United States)
ATC codeN06AX12
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 4

  • ndc11
    6584183605
    500 TABLET, EXTENDED RELEASE in 1 BOTTLE (65841-836-05)
  • ndc11
    6584183606
    30 TABLET, EXTENDED RELEASE in 1 BOTTLE (65841-836-06)
  • ndc11
    6584183610
    1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (65841-836-10)
  • ndc11
    6584183616
    90 TABLET, EXTENDED RELEASE in 1 BOTTLE (65841-836-16)

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": "65841-836_6c831525-a7c2-4ef1-b1b9-c7e8cb807ded",
  "productndc": "65841-836",
  "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": "20180802",
  "active_numerator_strength": "150"
}

Related drugs

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