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United States · US · US:75907-301_9b9c1567-01d0-461a-ad71-d661de6b212d

Habitrol Nicotine Polacrilex Gum 2 mg Coated Fruit

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 · 3

  • ndc11
    7590730110
    10 GUM, CHEWING in 1 BLISTER PACK (75907-301-10)
  • ndc11
    7590730115
    15 BLISTER PACK in 1 CARTON (75907-301-15) / 10 GUM, CHEWING in 1 BLISTER PACK
  • ndc11
    7590730180
    8 BLISTER PACK in 1 CARTON (75907-301-80) / 10 GUM, CHEWING in 1 BLISTER PACK

Annotations

UNII (FDA Substance ID)
6M3C89ZY6R
NICOTINE
RxCUI 7407
Orange Book
A079044
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": "75907-301_9b9c1567-01d0-461a-ad71-d661de6b212d",
  "productndc": "75907-301",
  "dosage_form": "GUM, CHEWING",
  "orange_book": {
    "appl_no": "079044",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "EQ 2MG 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 Gum 2 mg Coated Fruit",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA079044",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Nicotine Polacrilex",
  "start_marketing_date": "20250612",
  "active_numerator_strength": "2"
}

Related drugs

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