NICODERM

Orange BookUNIISPLATC N07BA01

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

Identification

ManufacturerHaleon US Holdings LLC

CountryUS (United States)

ATC codeN07BA01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 4

ndc11
0135019401
7 PATCH in 1 CARTON (0135-0194-01) / 24 h in 1 PATCH
ndc11
0135019402
14 PATCH in 1 CARTON (0135-0194-02) / 24 h in 1 PATCH
ndc11
0135019403
1 CARTON in 1 PACKAGE (0135-0194-03) / 21 PATCH in 1 CARTON / 24 h in 1 PATCH
ndc11
0135019405
14 PATCH in 1 CARTON (0135-0194-05) / 24 h in 1 PATCH (0135-0194-08)

Annotations

UNII (FDA Substance ID)

6M3C89ZY6R

NICOTINE

RxCUI 7407

Orange Book

N020165

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": {
    "93b2d1b9-83c1-40b5-b6af-90c38c8d6cef": {
      "match": "brand_token",
      "title": "NICODERM CQ (NICOTINE) PATCH, EXTENDED RELEASE [HALEON US HOLDINGS LLC]",
      "spl_version": "14",
      "published_date": "2025-07-16"
    }
  },
  "productid": "0135-0194_39e81d62-9ad8-8f7f-e063-6394a90a17b2",
  "productndc": "0135-0194",
  "dosage_form": "PATCH, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "020165",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "21MG/24HR",
        "product_no": "004",
        "approval_date": "Aug 2, 1996"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "14MG/24HR",
        "product_no": "005",
        "approval_date": "Aug 2, 1996"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "7MG/24HR",
        "product_no": "006",
        "approval_date": "Aug 2, 1996"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "NICOTINE",
  "proprietary_name": "NICODERM",
  "active_ingred_unit": "mg/24h",
  "application_number": "NDA020165",
  "marketing_category": "NDA",
  "nonproprietary_name": "nicotine",
  "start_marketing_date": "20110512",
  "active_numerator_strength": "21"
}

Related drugs

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