Habitrol Nicotine Polacrilex 4 mg Coated Cinnamon

Orange BookUNIISPLATC N07BA01

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

Identification

ManufacturerDr. Reddy's Laboratories Inc.

CountryUS (United States)

ATC codeN07BA01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 3

ndc11
5574100110
10 GUM, CHEWING in 1 BLISTER PACK (55741-001-10)
ndc11
5574100115
15 BLISTER PACK in 1 CARTON (55741-001-15) / 10 GUM, CHEWING in 1 BLISTER PACK
ndc11
5574100180
8 BLISTER PACK in 1 CARTON (55741-001-80) / 10 GUM, CHEWING in 1 BLISTER PACK

Annotations

UNII (FDA Substance ID)

6M3C89ZY6R

NICOTINE

RxCUI 7407

Orange Book

A079219

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": {
    "5d3b45d6-97c2-4400-ad09-95a4b21f5324": {
      "match": "brand_token",
      "title": "HABITROL NICOTINE POLACRILEX GUM 4 MG COATED FRUIT (NICOTINE POLACRILEX) GUM, CHEWING [DR. REDDY'S LABORATORIES INC.]",
      "spl_version": "10",
      "published_date": "2025-12-24"
    }
  },
  "productid": "55741-001_bbc0d741-c935-487d-94ad-8e8eb77a70bc",
  "productndc": "55741-001",
  "dosage_form": "GUM, CHEWING",
  "orange_book": {
    "appl_no": "079219",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "EQ 4MG BASE",
        "product_no": "001",
        "approval_date": "Jul 8, 2009"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "NICOTINE",
  "proprietary_name": "Habitrol Nicotine Polacrilex 4 mg Coated Cinnamon",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA079219",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Nicotine Polacrilex",
  "start_marketing_date": "20250728",
  "active_numerator_strength": "4"
}

Related drugs

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