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United States · US · US:55741-449_bed562f2-f5b3-632b-4b2c-fdf34a061098

nicotine

Orange BookSPL

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

Identification

ManufacturerDr. Reddy's Laboratories Inc.
CountryUS (United States)
ATC code
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    5574144956
    56 PATCH in 1 CARTON (55741-449-56) / 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": "55741-449_bed562f2-f5b3-632b-4b2c-fdf34a061098",
  "productndc": "55741-449",
  "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": "20150514",
  "active_numerator_strength": null
}

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