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United States · US · US:0135-0510_142b2250-8264-423f-e063-6394a90ab05b

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 · 3

  • ndc11
    0135051001
    3 CONTAINER in 1 CARTON (0135-0510-01) / 24 LOZENGE in 1 CONTAINER
  • ndc11
    0135051006
    1 CONTAINER in 1 CARTON (0135-0510-06) / 24 LOZENGE in 1 CONTAINER
  • ndc11
    0135051007
    6 CONTAINER in 1 CARTON (0135-0510-07) / 24 LOZENGE in 1 CONTAINER

Annotations

UNII (FDA Substance ID)
6M3C89ZY6R
NICOTINE
RxCUI 7407
Orange Book
N021330
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": "0135-0510_142b2250-8264-423f-e063-6394a90ab05b",
  "productndc": "0135-0510",
  "dosage_form": "LOZENGE",
  "orange_book": {
    "appl_no": "021330",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "EQ 2MG BASE",
        "product_no": "001",
        "approval_date": "Oct 31, 2002"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "EQ 4MG BASE",
        "product_no": "002",
        "approval_date": "Oct 31, 2002"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "NICOTINE",
  "proprietary_name": "NICORETTE",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA021330",
  "marketing_category": "NDA",
  "nonproprietary_name": "nicotine polacrilex",
  "start_marketing_date": "20101019",
  "active_numerator_strength": "2"
}

Related drugs

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