Bupropion hydrochloride (XL)

Orange BookUNIISPLATC N06AX12

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

Identification

ManufacturerLannett Company Inc.

CountryUS (United States)

ATC codeN06AX12

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 4

ndc11
0527243032
30 TABLET, EXTENDED RELEASE in 1 BOTTLE (0527-2430-32)
ndc11
0527243041
500 TABLET, EXTENDED RELEASE in 1 BOTTLE (0527-2430-41)
ndc11
0527243043
1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (0527-2430-43)
ndc11
0527243046
90 TABLET, EXTENDED RELEASE in 1 BOTTLE (0527-2430-46)

Annotations

UNII (FDA Substance ID)

ZG7E5POY8O

BUPROPION HYDROCHLORIDE

RxCUI 203204

Orange Book

A208652

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": "0527-2430_5e3c0247-0f79-454e-b14d-1e7dfd1a765e",
  "productndc": "0527-2430",
  "dosage_form": "TABLET, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "208652",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB3",
        "strength": "150MG",
        "product_no": "001",
        "approval_date": "Aug 21, 2017"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB3",
        "strength": "300MG",
        "product_no": "002",
        "approval_date": "Aug 21, 2017"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "BUPROPION HYDROCHLORIDE",
  "proprietary_name": "Bupropion hydrochloride (XL)",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA208652",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Bupropion hydrochloride",
  "start_marketing_date": "20180108",
  "active_numerator_strength": "300"
}

Related drugs

Other records sharing ATC code N06AX12.

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