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United States · US · US:43598-983_71e4d8bd-c716-3f2d-2ee7-b13406a53939

Habitrol Lozenge

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 · 2

  • ndc11
    4359898313
    5 BOTTLE in 1 CARTON (43598-983-13) / 27 LOZENGE in 1 BOTTLE
  • ndc11
    4359898327
    1 BOTTLE in 1 CARTON (43598-983-27) / 27 LOZENGE in 1 BOTTLE

Annotations

UNII (FDA Substance ID)
6M3C89ZY6R
NICOTINE
RxCUI 7407
Orange Book
A212983
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": "43598-983_71e4d8bd-c716-3f2d-2ee7-b13406a53939",
  "productndc": "43598-983",
  "dosage_form": "LOZENGE",
  "orange_book": {
    "appl_no": "212983",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "EQ 2MG BASE",
        "product_no": "001",
        "approval_date": "Feb 21, 2020"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "EQ 4MG BASE",
        "product_no": "002",
        "approval_date": "Feb 21, 2020"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "NICOTINE",
  "proprietary_name": "Habitrol Lozenge",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA212983",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Nicotine Polacrilex",
  "start_marketing_date": "20220401",
  "active_numerator_strength": "4"
}

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