Nicotine

Orange BookUNIISPLATC N07BA01

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerHC Jones, Inc.

CountryUS (United States)

ATC codeN07BA01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 3

ndc11
8325397827
27 LOZENGE in 1 BOTTLE, PLASTIC (83253-978-27)
ndc11
8325397872
1 BOTTLE, PLASTIC in 1 BOX (83253-978-72) / 27 LOZENGE in 1 BOTTLE, PLASTIC
ndc11
8325397881
3 BOTTLE, PLASTIC in 1 BOX (83253-978-81) / 27 LOZENGE in 1 BOTTLE, PLASTIC

Annotations

UNII (FDA Substance ID)

6M3C89ZY6R

NICOTINE

RxCUI 7407

Orange Book

A210711

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": "83253-978_5139e102-27df-4d31-ab96-0bdac80ec058",
  "productndc": "83253-978",
  "dosage_form": "LOZENGE",
  "orange_book": {
    "appl_no": "210711",
    "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",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA210711",
  "marketing_category": "ANDA",
  "nonproprietary_name": "nicotine polacrilex",
  "start_marketing_date": "20250331",
  "active_numerator_strength": "2"
}

Related drugs

Other records sharing ATC code N07BA01.

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