nicotine polacrilex coated mint (70000-0347)

Drug Facts

Product Profile

Brand Name nicotine polacrilex coated mint

Generic Name nicotine polacrilex

Labeler cardinal health (leader) 70000

Dosage Form GUM, CHEWING

Routes

BUCCAL

Active Ingredients

nicotine 2 mg/1

Manufacturer

Cardinal Health (Leader) 70000

Identifiers & Regulatory

Product NDC 70000-0347

Product ID 70000-0347_9afbc4b9-65fe-4527-a42d-9e41a82cb71f

Product Type HUMAN OTC DRUG

Marketing Category ANDA

Application Number ANDA078699

Listing Expiration 2026-12-31

Marketing Start 2018-07-03

Pharmacologic Class

Established (EPC)

cholinergic nicotinic agonist [epc]

Chemical Structure

nicotine [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 700000347

Hyphenated Format 70000-0347

Supplemental Identifiers

RxCUI

311975 314119

UPC

0096295133752 0096295133790

UNII

6M3C89ZY6R

NUI

N0000175706 M0014836

Packaging Origin

Original Packager

true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name nicotine polacrilex coated mint (source: ndc)

Generic Name nicotine polacrilex (source: ndc)

Application Number ANDA078699 (source: ndc)

Routes

BUCCAL

source: ndc

Resolved Composition

Strengths

2 mg/1

source: ndc

Packaging

10 BLISTER PACK in 1 CARTON (70000-0347-1) / 1 GUM, CHEWING in 1 BLISTER PACK

source: ndc

Packages (1)

70000-0347-1 10 BLISTER PACK in 1 CARTON (70000-0347-1) / 1 GUM, CHEWING in 1 BLISTER PACK

Ingredients (1)

nicotine (2 mg/1)

Linked Drug Pages (1)

Nicotine Polacrilex Coated Mint ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

{"route": ["BUCCAL"], "spl_id": "9afbc4b9-65fe-4527-a42d-9e41a82cb71f", "openfda": {"nui": ["N0000175706", "M0014836"], "upc": ["0096295133752", "0096295133790"], "unii": ["6M3C89ZY6R"], "rxcui": ["311975", "314119"], "spl_set_id": ["2c420ee4-0ed0-4a3f-bc92-202d825d0ca3"], "pharm_class_cs": ["Nicotine [CS]"], "pharm_class_epc": ["Cholinergic Nicotinic Agonist [EPC]"], "manufacturer_name": ["Cardinal Health (Leader) 70000"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 BLISTER PACK in 1 CARTON (70000-0347-1)  / 1 GUM, CHEWING in 1 BLISTER PACK", "package_ndc": "70000-0347-1", "marketing_start_date": "20180703"}], "brand_name": "Nicotine Polacrilex Coated Mint", "product_id": "70000-0347_9afbc4b9-65fe-4527-a42d-9e41a82cb71f", "dosage_form": "GUM, CHEWING", "pharm_class": ["Cholinergic Nicotinic Agonist [EPC]", "Nicotine [CS]"], "product_ndc": "70000-0347", "generic_name": "Nicotine Polacrilex", "labeler_name": "Cardinal Health (Leader) 70000", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Nicotine Polacrilex", "brand_name_suffix": "Coated Mint", "active_ingredients": [{"name": "NICOTINE", "strength": "2 mg/1"}], "application_number": "ANDA078699", "marketing_category": "ANDA", "marketing_start_date": "20180703", "listing_expiration_date": "20261231"}