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United States · US · US:50090-1694_91b95e4b-92df-40cc-9875-bec23c0d4475

Nicotine

Orange BookUNIISPLATC N07BA01

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

Identification

ManufacturerA-S Medication Solutions
CountryUS (United States)
ATC codeN07BA01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    5009016940
    14 POUCH in 1 CARTON (50090-1694-0) / 1 h in 1 POUCH

Annotations

UNII (FDA Substance ID)
6M3C89ZY6R
NICOTINE
RxCUI 7407
Orange Book
A074612
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": "50090-1694_91b95e4b-92df-40cc-9875-bec23c0d4475",
  "productndc": "50090-1694",
  "dosage_form": "PATCH",
  "orange_book": {
    "appl_no": "074612",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "21MG/24HR",
        "product_no": "001",
        "approval_date": "Oct 20, 1997"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "7MG/24HR",
        "product_no": "002",
        "approval_date": "Jul 28, 2003"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "14MG/24HR",
        "product_no": "003",
        "approval_date": "Oct 20, 1997"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "NICOTINE",
  "proprietary_name": "Nicotine",
  "active_ingred_unit": "mg/24h",
  "application_number": "ANDA074612",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Nicotine",
  "start_marketing_date": "19971020",
  "active_numerator_strength": "7"
}

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