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United States · US · US:68001-613_48e4e5a0-3a1f-3aa1-e063-6394a90ad05f

Bupropion hydrochloride

Orange BookUNIISPLATC N06AX12

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

Identification

ManufacturerBluePoint Laboratories
CountryUS (United States)
ATC codeN06AX12
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 3

  • ndc11
    6800161303
    500 TABLET in 1 BOTTLE (68001-613-03)
  • ndc11
    6800161304
    30 TABLET in 1 BOTTLE (68001-613-04)
  • ndc11
    6800161305
    90 TABLET in 1 BOTTLE (68001-613-05)

Annotations

UNII (FDA Substance ID)
ZG7E5POY8O
BUPROPION HYDROCHLORIDE
RxCUI 203204
Orange Book
A215568
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": "68001-613_48e4e5a0-3a1f-3aa1-e063-6394a90ad05f",
  "productndc": "68001-613",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "215568",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB3",
        "strength": "150MG",
        "product_no": "001",
        "approval_date": "Feb 2, 2022"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB3",
        "strength": "300MG",
        "product_no": "002",
        "approval_date": "Feb 2, 2022"
      }
    ],
    "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": "ANDA215568",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Bupropion hydrochloride",
  "start_marketing_date": "20240408",
  "active_numerator_strength": "150"
}

Related drugs

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