Bupropion hydrochloride

Orange BookUNIISPLATC N06AX12

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

Identification

ManufacturerSun Pharmaceutical Industries, Inc.

CountryUS (United States)

ATC codeN06AX12

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 4

ndc11
4733573808
100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (47335-738-08)
ndc11
4733573813
500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (47335-738-13)
ndc11
4733573886
60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (47335-738-86)
ndc11
4733573888
100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (47335-738-88)

Annotations

UNII (FDA Substance ID)

ZG7E5POY8O

BUPROPION HYDROCHLORIDE

RxCUI 203204

Orange Book

A078866

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": "47335-738_b8e6ae63-c5d7-4481-b7b0-17e135670515",
  "productndc": "47335-738",
  "dosage_form": "TABLET, FILM COATED, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "078866",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "100MG",
        "product_no": "001",
        "approval_date": "Apr 6, 2010"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "150MG",
        "product_no": "002",
        "approval_date": "Apr 6, 2010"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "200MG",
        "product_no": "003",
        "approval_date": "Apr 6, 2010"
      }
    ],
    "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": "ANDA078866",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Bupropion hydrochloride",
  "start_marketing_date": "20200301",
  "active_numerator_strength": "200"
}

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