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United States · US · US:63868-733_618550c1-391c-c6a7-c2b5-19d3bfc78419

Nicotine Polacrilex Lozenge Mint

Orange BookUNIISPLATC N07BA01

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

Identification

ManufacturerChain Drug Marketing Association INC
CountryUS (United States)
ATC codeN07BA01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    6386873324
    1 BOTTLE in 1 CARTON (63868-733-24) / 24 LOZENGE in 1 BOTTLE
  • ndc11
    6386873372
    3 BOTTLE in 1 CARTON (63868-733-72) / 24 LOZENGE in 1 BOTTLE

Annotations

UNII (FDA Substance ID)
6M3C89ZY6R
NICOTINE
RxCUI 7407
Orange Book
A212796
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": {
    "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": "63868-733_618550c1-391c-c6a7-c2b5-19d3bfc78419",
  "productndc": "63868-733",
  "dosage_form": "LOZENGE",
  "orange_book": {
    "appl_no": "212796",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "EQ 2MG BASE",
        "product_no": "001",
        "approval_date": "Jan 8, 2020"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "EQ 4MG BASE",
        "product_no": "002",
        "approval_date": "Jan 8, 2020"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "NICOTINE",
  "proprietary_name": "Nicotine Polacrilex Lozenge Mint",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA212796",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Nicotine Polacrilex Lozenge 2 mg",
  "start_marketing_date": "20210401",
  "active_numerator_strength": "2"
}

Related drugs

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