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United States · US · US:72888-187_4859954c-e904-be9f-e063-6294a90a1804

Nicotine Mini

Orange BookUNIISPLATC N07BA01

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

Identification

ManufacturerAdvagen Pharma Limited
CountryUS (United States)
ATC codeN07BA01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 4

  • ndc11
    7288818753
    1 BOTTLE in 1 CARTON (72888-187-53) / 27 LOZENGE in 1 BOTTLE
  • ndc11
    7288818754
    3 BOTTLE in 1 CARTON (72888-187-54) / 27 LOZENGE in 1 BOTTLE
  • ndc11
    7288818755
    4 BOTTLE in 1 CARTON (72888-187-55) / 27 LOZENGE in 1 BOTTLE
  • ndc11
    7288818756
    5 BOTTLE in 1 CARTON (72888-187-56) / 27 LOZENGE in 1 BOTTLE

Annotations

UNII (FDA Substance ID)
6M3C89ZY6R
NICOTINE
RxCUI 7407
Orange Book
A208875
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": "72888-187_4859954c-e904-be9f-e063-6294a90a1804",
  "productndc": "72888-187",
  "dosage_form": "LOZENGE",
  "orange_book": {
    "appl_no": "208875",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "EQ 2MG BASE",
        "product_no": "001",
        "approval_date": "Oct 31, 2019"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "EQ 4MG BASE",
        "product_no": "002",
        "approval_date": "Oct 31, 2019"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "NICOTINE",
  "proprietary_name": "Nicotine Mini",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA208875",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Nicotine Polacrilex",
  "start_marketing_date": "20230414",
  "active_numerator_strength": "4"
}

Related drugs

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