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United States · US · US:72516-035_47afeb95-a677-8969-e063-6294a90a7b2d

buPropion Hydrochloride

Orange BookUNIISPLATC N06AX12

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

Identification

ManufacturerOryza pharmaceuticals Inc.
CountryUS (United States)
ATC codeN06AX12
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 3

  • ndc11
    7251603503
    30 TABLET, EXTENDED RELEASE in 1 BOTTLE (72516-035-03)
  • ndc11
    7251603509
    90 TABLET, EXTENDED RELEASE in 1 BOTTLE (72516-035-09)
  • ndc11
    7251603550
    500 TABLET, EXTENDED RELEASE in 1 BOTTLE (72516-035-50)

Annotations

UNII (FDA Substance ID)
ZG7E5POY8O
BUPROPION HYDROCHLORIDE
RxCUI 203204
Orange Book
A211200
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": "72516-035_47afeb95-a677-8969-e063-6294a90a7b2d",
  "productndc": "72516-035",
  "dosage_form": "TABLET, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "211200",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB3",
        "strength": "300MG",
        "product_no": "001",
        "approval_date": "Sep 5, 2019"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB3",
        "strength": "150MG",
        "product_no": "002",
        "approval_date": "Apr 29, 2020"
      }
    ],
    "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": "ANDA211200",
  "marketing_category": "ANDA",
  "nonproprietary_name": "bupropion hydrochloride",
  "start_marketing_date": "20201001",
  "active_numerator_strength": "150"
}

Related drugs

Other records sharing ATC code N06AX12.

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