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United States · US · US:69842-217_5f0324e3-b546-4cdc-af4d-e45e2052a179

Nicotine Polacrilex

Orange BookUNIISPLATC N07BA01

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

Identification

ManufacturerCVS Pharmacy
CountryUS (United States)
ATC codeN07BA01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 3

  • ndc11
    6984221715
    20 BLISTER PACK in 1 CARTON (69842-217-15) / 1 GUM, CHEWING in 1 BLISTER PACK
  • ndc11
    6984221716
    160 BLISTER PACK in 1 CARTON (69842-217-16) / 1 GUM, CHEWING in 1 BLISTER PACK
  • ndc11
    6984221744
    100 BLISTER PACK in 1 CARTON (69842-217-44) / 1 GUM, CHEWING in 1 BLISTER PACK

Annotations

UNII (FDA Substance ID)
6M3C89ZY6R
NICOTINE
RxCUI 7407
Orange Book
A204833
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": "BUCCAL",
  "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": "69842-217_5f0324e3-b546-4cdc-af4d-e45e2052a179",
  "productndc": "69842-217",
  "dosage_form": "GUM, CHEWING",
  "orange_book": {
    "appl_no": "204833",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "EQ 4MG BASE",
        "product_no": "001",
        "approval_date": "Feb 26, 2016"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "NICOTINE",
  "proprietary_name": "Nicotine Polacrilex",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA204833",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Nicotine Polacrilex Gum",
  "start_marketing_date": "20160501",
  "active_numerator_strength": "4"
}

Related drugs

Other records sharing ATC code N07BA01.

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