nicotine polacrilex coated mint (68016-281)

Drug Facts

Product Profile

Brand Name nicotine polacrilex coated mint

Generic Name nicotine polacrilex

Labeler chain drug consortium, llc

Dosage Form GUM, CHEWING

Routes

BUCCAL

Active Ingredients

nicotine 4 mg/1

Manufacturer

Chain Drug Consortium, LLC

Identifiers & Regulatory

Product NDC 68016-281

Product ID 68016-281_13b30eab-efff-49bd-b18d-24abb709b755

Product Type HUMAN OTC DRUG

Marketing Category ANDA

Application Number ANDA078697

Marketing Start 2013-06-01

Marketing End 2026-12-31

Pharmacologic Class

Established (EPC)

cholinergic nicotinic agonist [epc]

Chemical Structure

nicotine [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68016281

Hyphenated Format 68016-281

Supplemental Identifiers

RxCUI

311975 314119

UPC

0840986031090 0840986029868 0840986031106

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 ANDA078697 (source: ndc)

Routes

BUCCAL

source: ndc

Resolved Composition

Strengths

4 mg/1

source: ndc

Packaging

4 BLISTER PACK in 1 CARTON (68016-281-49) / 10 GUM, CHEWING in 1 BLISTER PACK

source: ndc

Packages (1)

68016-281-49 4 BLISTER PACK in 1 CARTON (68016-281-49) / 10 GUM, CHEWING in 1 BLISTER PACK

Ingredients (1)

nicotine (4 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": "13b30eab-efff-49bd-b18d-24abb709b755", "openfda": {"nui": ["N0000175706", "M0014836"], "upc": ["0840986031090", "0840986029868", "0840986031106"], "unii": ["6M3C89ZY6R"], "rxcui": ["311975", "314119"], "spl_set_id": ["b4ac0a22-3556-4591-aa7b-e09c6010adc8"], "pharm_class_cs": ["Nicotine [CS]"], "pharm_class_epc": ["Cholinergic Nicotinic Agonist [EPC]"], "manufacturer_name": ["Chain Drug Consortium, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "4 BLISTER PACK in 1 CARTON (68016-281-49)  / 10 GUM, CHEWING in 1 BLISTER PACK", "package_ndc": "68016-281-49", "marketing_end_date": "20261231", "marketing_start_date": "20130601"}], "brand_name": "Nicotine Polacrilex Coated Mint", "product_id": "68016-281_13b30eab-efff-49bd-b18d-24abb709b755", "dosage_form": "GUM, CHEWING", "pharm_class": ["Cholinergic Nicotinic Agonist [EPC]", "Nicotine [CS]"], "product_ndc": "68016-281", "generic_name": "Nicotine Polacrilex", "labeler_name": "Chain Drug Consortium, LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Nicotine Polacrilex", "brand_name_suffix": "Coated Mint", "active_ingredients": [{"name": "NICOTINE", "strength": "4 mg/1"}], "application_number": "ANDA078697", "marketing_category": "ANDA", "marketing_end_date": "20261231", "marketing_start_date": "20130601"}