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United States · US · US:0187-5812_45372e42-065d-4d87-89af-d5dcf09c29fb

Aplenzin

Orange BookUNIISPLATC N06AX12

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

Identification

ManufacturerBausch Health US, LLC
CountryUS (United States)
ATC codeN06AX12
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    0187581207
    7 TABLET, EXTENDED RELEASE in 1 BOTTLE (0187-5812-07)
  • ndc11
    0187581230
    30 TABLET, EXTENDED RELEASE in 1 BOTTLE (0187-5812-30)

Annotations

UNII (FDA Substance ID)
E70G3G5863
BUPROPION HYDROBROMIDE
RxCUI 993548
Orange Book
N022108
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "E70G3G5863",
    "rxcui": "993548",
    "inchikey": "WSTCENNATOVXKQ-UHFFFAOYSA-N",
    "display_name": "BUPROPION HYDROBROMIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "6494d2d9-0ce4-4126-b1c7-49684395942b": {
      "match": "brand_token",
      "title": "APLENZIN (BUPROPION HYDROBROMIDE) TABLET, EXTENDED RELEASE [BAUSCH HEALTH US, LLC]",
      "spl_version": "27",
      "published_date": "2026-03-05"
    }
  },
  "productid": "0187-5812_45372e42-065d-4d87-89af-d5dcf09c29fb",
  "productndc": "0187-5812",
  "dosage_form": "TABLET, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "022108",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "174MG",
        "product_no": "001",
        "approval_date": "Apr 23, 2008"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "348MG",
        "product_no": "002",
        "approval_date": "Apr 23, 2008"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "522MG",
        "product_no": "003",
        "approval_date": "Apr 23, 2008"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "BUPROPION HYDROBROMIDE",
  "proprietary_name": "Aplenzin",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA022108",
  "marketing_category": "NDA",
  "nonproprietary_name": "bupropion hydrobromide",
  "start_marketing_date": "20080423",
  "active_numerator_strength": "522"
}

Related drugs

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