Habitrol Nicotine Polacrilex Gum 4 mg Coated Mint

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
7590730310
10 GUM, CHEWING in 1 BLISTER PACK (75907-303-10)
ndc11
7590730315
15 BLISTER PACK in 1 CARTON (75907-303-15) / 10 GUM, CHEWING in 1 BLISTER PACK
ndc11
7590730380
8 BLISTER PACK in 1 CARTON (75907-303-80) / 10 GUM, CHEWING in 1 BLISTER PACK

Annotations

UNII (FDA Substance ID)

6M3C89ZY6R

NICOTINE

RxCUI 7407

Orange Book

A078697

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": "75907-303_6dec3f9c-5e70-4992-aae4-822d470312a5",
  "productndc": "75907-303",
  "dosage_form": "GUM, CHEWING",
  "orange_book": {
    "appl_no": "078697",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "EQ 4MG BASE",
        "product_no": "001",
        "approval_date": "Dec 29, 2008"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "NICOTINE",
  "proprietary_name": "Habitrol Nicotine Polacrilex Gum 4 mg Coated Mint",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA078697",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Nicotine Polacrilex",
  "start_marketing_date": "20250612",
  "active_numerator_strength": "4"
}

Related drugs

Other records sharing ATC code N07BA01.

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