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United States · US · US:0135-0635_fd080df4-10ba-4b7e-a999-474f51610d2a

NICORETTE

Orange BookUNIISPLATC N07BA01

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

Identification

ManufacturerHaleon US Holdings LLC
CountryUS (United States)
ATC codeN07BA01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    0135063501
    3 CONTAINER in 1 CARTON (0135-0635-01) / 72 LOZENGE in 1 CONTAINER

Annotations

UNII (FDA Substance ID)
6M3C89ZY6R
NICOTINE
RxCUI 7407
Orange Book
A077007
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": {
    "35438b53-2760-bcfe-e063-6394a90a65c0": {
      "match": "brand_token",
      "title": "NICORETTE CHERRY PEPPERMINT (NICOTINE POLACRILEX) LOZENGE [HALEON US HOLDINGS LLC]",
      "spl_version": "2",
      "published_date": "2026-04-02"
    }
  },
  "productid": "0135-0635_fd080df4-10ba-4b7e-a999-474f51610d2a",
  "productndc": "0135-0635",
  "dosage_form": "LOZENGE",
  "orange_book": {
    "appl_no": "077007",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "EQ 2MG BASE",
        "product_no": "001",
        "approval_date": "Jan 31, 2006"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "EQ 4MG BASE",
        "product_no": "002",
        "approval_date": "Jan 31, 2006"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "NICOTINE",
  "proprietary_name": "NICORETTE",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA077007",
  "marketing_category": "ANDA",
  "nonproprietary_name": "nicotine polacrilex",
  "start_marketing_date": "20220601",
  "active_numerator_strength": "2"
}

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