NICOTINE

Orange BookUNIISPLATC N07BA01

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

Identification

ManufacturerAurohealth LLC

CountryUS (United States)

ATC codeN07BA01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 3

ndc11
5860272281
4 CONTAINER in 1 CARTON (58602-722-81) / 27 LOZENGE in 1 CONTAINER
ndc11
5860272284
3 CONTAINER in 1 CARTON (58602-722-84) / 27 LOZENGE in 1 CONTAINER
ndc11
5860272285
5 CONTAINER in 1 CARTON (58602-722-85) / 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": "58602-722_cfe6fb63-2897-4e76-8288-1389f363b3c4",
  "productndc": "58602-722",
  "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": "20221103",
  "active_numerator_strength": "2"
}

Related drugs

Other records sharing ATC code N07BA01.

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