Maxi Nicotine

Orange BookUNIISPLATC N07BA01

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

Identification

ManufacturerRugby Laboratories, Inc.

CountryUS (United States)

ATC codeN07BA01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 2

ndc11
0536133809
3 BOTTLE, PLASTIC in 1 BOX (0536-1338-09) / 24 LOZENGE in 1 BOTTLE, PLASTIC
ndc11
0536133835
24 LOZENGE in 1 BOTTLE, PLASTIC (0536-1338-35)

Annotations

UNII (FDA Substance ID)

6M3C89ZY6R

NICOTINE

RxCUI 7407

Orange Book

A209206

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": {
    "7a25d940-6aca-47fe-9c77-babef21a4c80": {
      "match": "brand_token",
      "title": "MAXI NICOTINE (NICOTINE POLACRILEX) LOZENGE [WALGREENS]",
      "spl_version": "5",
      "published_date": "2026-01-21"
    }
  },
  "productid": "0536-1338_21f25fb4-08b3-4f4f-ad3f-3b8e0c6836f2",
  "productndc": "0536-1338",
  "dosage_form": "LOZENGE",
  "orange_book": {
    "appl_no": "209206",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "EQ 2MG BASE",
        "product_no": "001",
        "approval_date": "Jun 26, 2018"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "EQ 4MG BASE",
        "product_no": "002",
        "approval_date": "Jun 26, 2018"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "NICOTINE",
  "proprietary_name": "Maxi Nicotine",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA209206",
  "marketing_category": "ANDA",
  "nonproprietary_name": "nicotine polacrilex",
  "start_marketing_date": "20210917",
  "active_numerator_strength": "4"
}

Related drugs

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