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 · 4

ndc11
5860290607
1 CONTAINER in 1 CARTON (58602-906-07) / 24 LOZENGE in 1 CONTAINER
ndc11
5860290651
3 CONTAINER in 1 CARTON (58602-906-51) / 24 LOZENGE in 1 CONTAINER
ndc11
5860290652
4 CONTAINER in 1 CARTON (58602-906-52) / 24 LOZENGE in 1 CONTAINER
ndc11
5860290665
6 CONTAINER in 1 CARTON (58602-906-65) / 24 LOZENGE in 1 CONTAINER

Annotations

UNII (FDA Substance ID)

6M3C89ZY6R

NICOTINE

RxCUI 7407

Orange Book

A213266

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": "58602-906_cbf094d4-2357-426d-8205-9b59c332854f",
  "productndc": "58602-906",
  "dosage_form": "LOZENGE",
  "orange_book": {
    "appl_no": "213266",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "EQ 2MG BASE",
        "product_no": "001",
        "approval_date": "Aug 3, 2021"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "EQ 4MG BASE",
        "product_no": "002",
        "approval_date": "Aug 3, 2021"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "NICOTINE",
  "proprietary_name": "NICOTINE",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA213266",
  "marketing_category": "ANDA",
  "nonproprietary_name": "NICOTINE POLACRILEX",
  "start_marketing_date": "20211029",
  "active_numerator_strength": "4"
}

Related drugs

Other records sharing ATC code N07BA01.

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