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United States · US · US:0173-0135_5ffc8b63-7d69-4f3a-bf05-a9c138724a91

WELLBUTRIN

Orange BookUNIISPLATC N06AX12

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

Identification

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

Packs · 1

  • ndc11
    0173013555
    60 TABLET, FILM COATED in 1 BOTTLE (0173-0135-55)

Annotations

UNII (FDA Substance ID)
ZG7E5POY8O
BUPROPION HYDROCHLORIDE
RxCUI 203204
Orange Book
N020358
AB1AB1AB1
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": {
    "cbc8c074-f080-4489-a5ae-207b5fadeba3": {
      "match": "brand_token",
      "title": "WELLBUTRIN SR (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED [GLAXOSMITHKLINE LLC]",
      "spl_version": "39",
      "published_date": "2026-04-30"
    }
  },
  "productid": "0173-0135_5ffc8b63-7d69-4f3a-bf05-a9c138724a91",
  "productndc": "0173-0135",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "020358",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "50MG",
        "product_no": "001",
        "approval_date": "Oct 4, 1996"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB1",
        "strength": "100MG",
        "product_no": "002",
        "approval_date": "Oct 4, 1996"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB1",
        "strength": "150MG",
        "product_no": "003",
        "approval_date": "Oct 4, 1996"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AB1",
        "strength": "200MG",
        "product_no": "004",
        "approval_date": "Jun 14, 2002"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "BUPROPION HYDROCHLORIDE",
  "proprietary_name": "WELLBUTRIN",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA020358",
  "marketing_category": "NDA",
  "nonproprietary_name": "bupropion hydrochloride",
  "start_marketing_date": "19961115",
  "active_numerator_strength": "150"
}

Related drugs

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