Bupropion HCL ER (XL)

Orange BookUNIISPLATC N06AX12

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerDirect_RX

CountryUS (United States)

ATC codeN06AX12

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 2

ndc11
7218953930
30 TABLET, EXTENDED RELEASE in 1 BOTTLE (72189-539-30)
ndc11
7218953990
90 TABLET, EXTENDED RELEASE in 1 BOTTLE (72189-539-90)

Annotations

UNII (FDA Substance ID)

ZG7E5POY8O

BUPROPION HYDROCHLORIDE

RxCUI 203204

Orange Book

A210015

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": "72189-539_19b02d9d-9104-0442-e063-6394a90a3154",
  "productndc": "72189-539",
  "dosage_form": "TABLET, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "210015",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB3",
        "strength": "150MG",
        "product_no": "001",
        "approval_date": "Jun 14, 2018"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB3",
        "strength": "300MG",
        "product_no": "002",
        "approval_date": "Jun 14, 2018"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "BUPROPION HYDROCHLORIDE",
  "proprietary_name": "Bupropion HCL ER (XL)",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA210015",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Bupropion HCL ER (XL)",
  "start_marketing_date": "20240301",
  "active_numerator_strength": "300"
}

Related drugs

Other records sharing ATC code N06AX12.

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