bupropion hydrochloride

Orange BookUNIISPLATC N06AX12

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

Identification

ManufacturerRising Pharma Holdings, Inc.

CountryUS (United States)

ATC codeN06AX12

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 5

ndc11
1657186203
30 TABLET, EXTENDED RELEASE in 1 BOTTLE (16571-862-03)
ndc11
1657186209
90 TABLET, EXTENDED RELEASE in 1 BOTTLE (16571-862-09)
ndc11
1657186210
1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (16571-862-10)
ndc11
1657186212
120 TABLET, EXTENDED RELEASE in 1 BOTTLE (16571-862-12)
ndc11
1657186250
500 TABLET, EXTENDED RELEASE in 1 BOTTLE (16571-862-50)

Annotations

UNII (FDA Substance ID)

ZG7E5POY8O

BUPROPION HYDROCHLORIDE

RxCUI 203204

Orange Book

A211020

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": "16571-862_fe42636a-ae04-43be-b032-8973bbdde7d5",
  "productndc": "16571-862",
  "dosage_form": "TABLET, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "211020",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB3",
        "strength": "150MG",
        "product_no": "001",
        "approval_date": "Jan 28, 2019"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB3",
        "strength": "300MG",
        "product_no": "002",
        "approval_date": "Jan 28, 2019"
      }
    ],
    "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": "ANDA211020",
  "marketing_category": "ANDA",
  "nonproprietary_name": "bupropion hydrochloride",
  "start_marketing_date": "20220801",
  "active_numerator_strength": "150"
}

Related drugs

Other records sharing ATC code N06AX12.

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