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United States · US · US:0009-5401_33997044-c41d-481b-b724-15463f892bd1

Nicotrol

Orange BookUNIISPLATC N07BA01

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

Identification

ManufacturerPharmacia & Upjohn Company LLC
CountryUS (United States)
ATC codeN07BA01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    0009540101
    4 BOTTLE, SPRAY in 1 BOX (0009-5401-01) / 10 mL in 1 BOTTLE, SPRAY

Annotations

UNII (FDA Substance ID)
6M3C89ZY6R
NICOTINE
RxCUI 7407
Orange Book
N020385
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": "NASAL",
  "spl_meta": {
    "acb7d02d-249b-4645-ac1b-8ff9a56dd244": {
      "match": "brand_token",
      "title": "NICOTROL (NICOTINE) SPRAY, METERED [PHARMACIA & UPJOHN COMPANY LLC]",
      "spl_version": "19",
      "published_date": "2025-06-02"
    }
  },
  "productid": "0009-5401_33997044-c41d-481b-b724-15463f892bd1",
  "productndc": "0009-5401",
  "dosage_form": "SPRAY, METERED",
  "orange_book": {
    "appl_no": "020385",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "0.5MG/SPRAY",
        "product_no": "001",
        "approval_date": "Mar 22, 1996"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "NICOTINE",
  "proprietary_name": "Nicotrol",
  "active_ingred_unit": "mg/mL",
  "application_number": "NDA020385",
  "marketing_category": "NDA",
  "nonproprietary_name": "nicotine",
  "start_marketing_date": "19960522",
  "active_numerator_strength": "10"
}

Related drugs

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