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United States · US · US:82966-002_cf7fbe21-9a76-4832-88a4-2ef371510784

NICOTINE

Orange BookUNIISPLATC N07BA01

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

Identification

ManufacturerBLIP PRODUCTS, INC.
CountryUS (United States)
ATC codeN07BA01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 3

  • ndc11
    8296600281
    4 CONTAINER in 1 CARTON (82966-002-81) / 27 LOZENGE in 1 CONTAINER
  • ndc11
    8296600283
    1 CONTAINER in 1 CARTON (82966-002-83) / 27 LOZENGE in 1 CONTAINER
  • ndc11
    8296600284
    3 CONTAINER in 1 CARTON (82966-002-84) / 27 LOZENGE in 1 CONTAINER

Annotations

UNII (FDA Substance ID)
6M3C89ZY6R
NICOTINE
RxCUI 7407
Orange Book
A215357
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": "82966-002_cf7fbe21-9a76-4832-88a4-2ef371510784",
  "productndc": "82966-002",
  "dosage_form": "LOZENGE",
  "orange_book": {
    "appl_no": "215357",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "EQ 2MG BASE",
        "product_no": "001",
        "approval_date": "May 13, 2022"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "EQ 4MG BASE",
        "product_no": "002",
        "approval_date": "May 13, 2022"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "NICOTINE",
  "proprietary_name": "NICOTINE",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA215357",
  "marketing_category": "ANDA",
  "nonproprietary_name": "NICOTINE POLACRILEX MINI",
  "start_marketing_date": "20230106",
  "active_numerator_strength": "4"
}

Related drugs

Other records sharing ATC code N07BA01.

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