Bupropion Hydrochloride

Orange BookUNIISPLATC N06AX12

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

Identification

ManufacturerAlembic Pharmaceuticals Inc.

CountryUS (United States)

ATC codeN06AX12

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 2

ndc11
6233212731
100 TABLET, FILM COATED in 1 BOTTLE (62332-127-31)
ndc11
6233212771
500 TABLET, FILM COATED in 1 BOTTLE (62332-127-71)

Annotations

UNII (FDA Substance ID)

ZG7E5POY8O

BUPROPION HYDROCHLORIDE

RxCUI 203204

Orange Book

A203013

ABAB

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": "62332-127_ee494cd8-6374-4c6a-86f6-722c999e43e1",
  "productndc": "62332-127",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "203013",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "75MG",
        "product_no": "001",
        "approval_date": "Jun 8, 2018"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "100MG",
        "product_no": "002",
        "approval_date": "Jun 8, 2018"
      }
    ],
    "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": "ANDA203013",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Bupropion Hydrochloride",
  "start_marketing_date": "20240110",
  "active_numerator_strength": "100"
}

Related drugs

Other records sharing ATC code N06AX12.

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