Rugby Nicotine Polacrilex Gum, Coated Mint Flavor

Orange BookUNIISPLATC N07BA01

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

Identification

ManufacturerRugby Laboratories

CountryUS (United States)

ATC codeN07BA01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 2

ndc11
0536311301
10 BLISTER PACK in 1 CARTON (0536-3113-01) / 10 GUM, CHEWING in 1 BLISTER PACK
ndc11
0536311337
4 BLISTER PACK in 1 CARTON (0536-3113-37) / 10 GUM, CHEWING in 1 BLISTER PACK

Annotations

UNII (FDA Substance ID)

6M3C89ZY6R

NICOTINE

RxCUI 7407

Orange Book

A078697

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": "BUCCAL",
  "spl_meta": {
    "50c46cf5-3e64-9e0f-e063-6294a90a2317": {
      "match": "brand_token",
      "title": "RUGBY ANTIFUNGAL (TOLNAFTATE AEROSOL, POWDER) AEROSOL, SPRAY [RUGBY LABORATORIES]",
      "spl_version": "2",
      "published_date": "2026-05-20"
    }
  },
  "productid": "0536-3113_665390ec-cda3-4603-883c-5593a4b40dd8",
  "productndc": "0536-3113",
  "dosage_form": "GUM, CHEWING",
  "orange_book": {
    "appl_no": "078697",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "EQ 4MG BASE",
        "product_no": "001",
        "approval_date": "Dec 29, 2008"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "NICOTINE",
  "proprietary_name": "Rugby Nicotine Polacrilex Gum, Coated Mint Flavor",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA078697",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Nicotine Polacrilex",
  "start_marketing_date": "20081229",
  "active_numerator_strength": "4"
}

Related drugs

Other records sharing ATC code N07BA01.

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