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United States · US · US:71610-866_d103c1fe-4d4c-48e2-8e30-494b19dd7e52

bupropion Hydrochloride

Orange BookUNIISPLATC N06AX12

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

Identification

ManufacturerAphena Pharma Solutions - Tennessee, LLC
CountryUS (United States)
ATC codeN06AX12
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 4

  • ndc11
    7161086653
    60 TABLET in 1 BOTTLE (71610-866-53)
  • ndc11
    7161086660
    90 TABLET in 1 BOTTLE (71610-866-60)
  • ndc11
    7161086670
    120 TABLET in 1 BOTTLE (71610-866-70)
  • ndc11
    7161086680
    180 TABLET in 1 BOTTLE (71610-866-80)

Annotations

UNII (FDA Substance ID)
ZG7E5POY8O
BUPROPION HYDROCHLORIDE
RxCUI 203204
Orange Book
A206975
ABAB
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": "71610-866_d103c1fe-4d4c-48e2-8e30-494b19dd7e52",
  "productndc": "71610-866",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "206975",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "75MG",
        "product_no": "001",
        "approval_date": "Aug 19, 2016"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "100MG",
        "product_no": "002",
        "approval_date": "Aug 19, 2016"
      }
    ],
    "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": "ANDA206975",
  "marketing_category": "ANDA",
  "nonproprietary_name": "bupropion Hydrochloride",
  "start_marketing_date": "20160819",
  "active_numerator_strength": "75"
}

Related drugs

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