NICOTINE

Orange BookUNIISPLATC N07BA01

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

Identification

ManufacturerPadagis Israel Pharmaceuticals Ltd

CountryUS (United States)

ATC codeN07BA01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
4580265125
110 BLISTER PACK in 1 CARTON (45802-651-25) / 1 GUM, CHEWING in 1 BLISTER PACK

Annotations

UNII (FDA Substance ID)

6M3C89ZY6R

NICOTINE

RxCUI 7407

Orange Book

A206393

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": "ORAL",
  "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": "45802-651_4a219ea1-7256-45df-8c6c-b9b7704ed5cc",
  "productndc": "45802-651",
  "dosage_form": "GUM, CHEWING",
  "orange_book": {
    "appl_no": "206393",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "EQ 4MG BASE",
        "product_no": "001",
        "approval_date": "Dec 15, 2016"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "NICOTINE",
  "proprietary_name": "NICOTINE",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA206393",
  "marketing_category": "ANDA",
  "nonproprietary_name": "nicotine polacrilex",
  "start_marketing_date": "20230814",
  "active_numerator_strength": "4"
}

Related drugs

Other records sharing ATC code N07BA01.

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