Nicotine Transdermal System

Orange BookUNIISPLATC N07BA01

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

Identification

ManufacturerAmerisourceBergen Drug Corporation

CountryUS (United States)

ATC codeN07BA01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
4612235274
14 POUCH in 1 CARTON (46122-352-74) / 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": "46122-352_4e523133-7733-a6e4-e063-6394a90a2e59",
  "productndc": "46122-352",
  "dosage_form": "PATCH, EXTENDED RELEASE",
  "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 Transdermal System",
  "active_ingred_unit": "mg/24h",
  "application_number": "ANDA074612",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Nicotine Transdermal System",
  "start_marketing_date": "20240625",
  "active_numerator_strength": "14"
}

Related drugs

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