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United States · US · US:51267-890_8e7e5582-7a35-4ec7-85e7-b88a98d1bd23

Contrave

Orange BookUNIISPLATC N06AX

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

Identification

ManufacturerNalpropion Pharmaceuticals LLC
CountryUS (United States)
ATC codeN06AX
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    5126789007
    7 TABLET, EXTENDED RELEASE in 1 BOTTLE (51267-890-07)
  • ndc11
    5126789099
    120 TABLET, EXTENDED RELEASE in 1 BOTTLE (51267-890-99)

Annotations

UNII (FDA Substance ID)
ZG7E5POY8O
BUPROPION HYDROCHLORIDE
RxCUI 203204
Orange Book
N200063
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": {
    "485ff360-32c8-11df-928b-0002a5d5c51b": {
      "match": "brand_token",
      "title": "CONTRAVE EXTENDED-RELEASE (NALTREXONE HYDROCHLORIDE AND BUPROPION HYDROCHLORIDE) TABLET, EXTENDED RELEASE [NALPROPION PHARMACEUTICALS LLC]",
      "spl_version": "27",
      "published_date": "2025-11-17"
    }
  },
  "productid": "51267-890_8e7e5582-7a35-4ec7-85e7-b88a98d1bd23",
  "productndc": "51267-890",
  "dosage_form": "TABLET, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "200063",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "90MG;8MG",
        "product_no": "001",
        "approval_date": "Sep 10, 2014"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "BUPROPION HYDROCHLORIDE; NALTREXONE HYDROCHLORIDE",
  "proprietary_name": "Contrave",
  "active_ingred_unit": "mg/1; mg/1",
  "application_number": "NDA200063",
  "marketing_category": "NDA",
  "nonproprietary_name": "naltrexone hydrochloride and bupropion hydrochloride",
  "start_marketing_date": "20141022",
  "active_numerator_strength": "90; 8"
}

Related drugs

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