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United States · US · US:68391-957_357123fc-0972-4683-ab52-f95d46c1b6c9

berkley and jensen nicotine

Orange BookUNIISPLATC N07BA01

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

Identification

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

Packs · 2

  • ndc11
    6839195701
    27 LOZENGE in 1 BOTTLE (68391-957-01)
  • ndc11
    6839195706
    7 BOTTLE in 1 PACKAGE (68391-957-06) / 27 LOZENGE in 1 BOTTLE

Annotations

UNII (FDA Substance ID)
6M3C89ZY6R
NICOTINE
RxCUI 7407
Orange Book
A203690
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": {
    "cda57e42-6106-46ee-82d1-479a692ee5bb": {
      "match": "brand_token",
      "title": "BERKLEY AND JENSEN IBUPROFEN (IBUPROFEN) TABLET, FILM COATED [BJWC]",
      "spl_version": "9",
      "published_date": "2026-05-25"
    }
  },
  "productid": "68391-957_357123fc-0972-4683-ab52-f95d46c1b6c9",
  "productndc": "68391-957",
  "dosage_form": "LOZENGE",
  "orange_book": {
    "appl_no": "203690",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "EQ 2MG BASE",
        "product_no": "001",
        "approval_date": "Oct 9, 2012"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "EQ 4MG BASE",
        "product_no": "002",
        "approval_date": "Oct 9, 2012"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "NICOTINE",
  "proprietary_name": "berkley and jensen nicotine",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA203690",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Nicotine Polacrilex",
  "start_marketing_date": "20171106",
  "active_numerator_strength": "4"
}

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