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United States · US · US:68001-698_4856e41f-dd51-0ee5-e063-6294a90a228f

Nicotine Transdermal System Patch

Orange BookUNIISPLATC N07BA01

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

Identification

ManufacturerBluePoint Laboratories
CountryUS (United States)
ATC codeN07BA01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    6800169888
    7 PATCH in 1 CARTON (68001-698-88) / 24 h in 1 PATCH
  • ndc11
    6800169890
    14 PATCH in 1 CARTON (68001-698-90) / 24 h in 1 PATCH

Annotations

UNII (FDA Substance ID)
6M3C89ZY6R
NICOTINE
RxCUI 7407
Orange Book
N020076
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "6M3C89ZY6R",
    "rxcui": "7407",
    "inchikey": "SNICXCGAKADSCV-JTQLQIEISA-N",
    "display_name": "NICOTINE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "TRANSDERMAL",
  "spl_meta": {
    "f1eb8d9f-1c9a-4c8a-833b-ced0ec01ed5c": {
      "match": "brand_token",
      "title": "NICOTINE (NICOTINE POLACRILEX) LOZENGE [RITE AID CORPORATION]",
      "spl_version": "5",
      "published_date": "2026-06-01"
    }
  },
  "productid": "68001-698_4856e41f-dd51-0ee5-e063-6294a90a228f",
  "productndc": "68001-698",
  "dosage_form": "PATCH, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "020076",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "7MG/24HR",
        "product_no": "004",
        "approval_date": "Nov 12, 1999"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "14MG/24HR",
        "product_no": "005",
        "approval_date": "Nov 12, 1999"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "21MG/24HR",
        "product_no": "006",
        "approval_date": "Nov 12, 1999"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "NICOTINE",
  "proprietary_name": "Nicotine Transdermal System Patch",
  "active_ingred_unit": "mg/24h",
  "application_number": "NDA020076",
  "marketing_category": "NDA",
  "nonproprietary_name": "Nicotine Transdermal System Patch",
  "start_marketing_date": "20260511",
  "active_numerator_strength": "14"
}

Related drugs

Other records sharing ATC code N07BA01.

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