Habitrol

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 · 2

ndc11
5574144770
7 PATCH in 1 CARTON (55741-447-70) / 24 h in 1 PATCH
ndc11
5574144774
14 PATCH in 1 CARTON (55741-447-74) / 24 h in 1 PATCH

Annotations

UNII (FDA Substance ID)

6M3C89ZY6R

NICOTINE

RxCUI 7407

Orange Book

N020076

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": "TRANSDERMAL",
  "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": "55741-447_7b8f92dc-a9f4-6c9c-d0ca-bd8f89cbd875",
  "productndc": "55741-447",
  "dosage_form": "PATCH, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "020076",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "7MG/24HR",
        "product_no": "004",
        "approval_date": "Nov 12, 1999"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "14MG/24HR",
        "product_no": "005",
        "approval_date": "Nov 12, 1999"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "21MG/24HR",
        "product_no": "006",
        "approval_date": "Nov 12, 1999"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "NICOTINE",
  "proprietary_name": "Habitrol",
  "active_ingred_unit": "mg/24h",
  "application_number": "NDA020076",
  "marketing_category": "NDA",
  "nonproprietary_name": "Nicotine Transdermal System Patch",
  "start_marketing_date": "20180713",
  "active_numerator_strength": "14"
}

Related drugs

Other records sharing ATC code N07BA01.

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