Back to search
🇺🇸

United States · US · US:43598-987_f9d24ed4-6477-a9bf-c3e2-ac408911a310

Habitrol

Orange BookUNIISPLATC N07BA01

Last synced from FDA National Drug Code directory (United States) on

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 · 4

  • ndc11
    4359898713
    5 BOTTLE in 1 CARTON (43598-987-13) / 27 LOZENGE in 1 BOTTLE
  • ndc11
    4359898724
    1 BOTTLE in 1 CARTON (43598-987-24) / 24 LOZENGE in 1 BOTTLE
  • ndc11
    4359898727
    1 BOTTLE in 1 CARTON (43598-987-27) / 27 LOZENGE in 1 BOTTLE
  • ndc11
    4359898772
    3 BOTTLE in 1 CARTON (43598-987-72) / 24 LOZENGE in 1 BOTTLE

Annotations

UNII (FDA Substance ID)
6M3C89ZY6R
NICOTINE
RxCUI 7407
Orange Book
A212796
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": "43598-987_f9d24ed4-6477-a9bf-c3e2-ac408911a310",
  "productndc": "43598-987",
  "dosage_form": "LOZENGE",
  "orange_book": {
    "appl_no": "212796",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "EQ 2MG BASE",
        "product_no": "001",
        "approval_date": "Jan 8, 2020"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "EQ 4MG BASE",
        "product_no": "002",
        "approval_date": "Jan 8, 2020"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "NICOTINE",
  "proprietary_name": "Habitrol",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA212796",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Nicotine Polacrilex Lozenge 4 mg",
  "start_marketing_date": "20210521",
  "active_numerator_strength": "4"
}

Related drugs

Other records sharing ATC code N07BA01.

Access this data programmatically

Query Habitrol and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.