NICOTINE

Orange BookSPL

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

Identification

ManufacturerRite Aid Corporation

CountryUS (United States)

ATC code—

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
1182236273
56 PATCH in 1 CARTON (11822-3627-3) / 1 KIT in 1 PATCH

Annotations

Orange Book

N020076

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "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": "11822-3627_cc8505c5-38ba-5bb3-5c4d-0e7a1984eae4",
  "productndc": "11822-3627",
  "dosage_form": "KIT",
  "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": null,
  "proprietary_name": "NICOTINE",
  "active_ingred_unit": null,
  "application_number": "NDA020076",
  "marketing_category": "NDA",
  "nonproprietary_name": "NICOTINE",
  "start_marketing_date": "20210331",
  "active_numerator_strength": null
}

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