nicotine polacrilex, original

Generic: nicotine polacrilex

Labeler: chain drug consortium, llc
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name nicotine polacrilex, original
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 68016-287
Product ID 68016-287_b3555bc9-16a9-4ba6-a2cb-5c40ac2129c4
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA074707
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 68016287
Hyphenated Format 68016-287

Supplemental Identifiers

RxCUI
311975 314119
UPC
0840986029875 0840986029882
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, original (source: ndc)
Generic Name nicotine polacrilex (source: ndc)
Application Number ANDA074707 (source: ndc)
Routes
BUCCAL
source: ndc

Resolved Composition

Strengths
  • 4 mg/1
source: ndc
Packaging
  • 11 BLISTER PACK in 1 CARTON (68016-287-62) / 10 GUM, CHEWING in 1 BLISTER PACK
source: ndc

Packages (1)

68016-287-62 11 BLISTER PACK in 1 CARTON (68016-287-62) / 10 GUM, CHEWING in 1 BLISTER PACK

Ingredients (1)

nicotine (4 mg/1)

Linked Drug Pages (1)

Nicotine Polacrilex, Original ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["BUCCAL"], "spl_id": "b3555bc9-16a9-4ba6-a2cb-5c40ac2129c4", "openfda": {"nui": ["N0000175706", "M0014836"], "upc": ["0840986029875", "0840986029882"], "unii": ["6M3C89ZY6R"], "rxcui": ["311975", "314119"], "spl_set_id": ["cb67cd5e-9264-4530-a678-da299476f356"], "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": "11 BLISTER PACK in 1 CARTON (68016-287-62)  / 10 GUM, CHEWING in 1 BLISTER PACK", "package_ndc": "68016-287-62", "marketing_end_date": "20261231", "marketing_start_date": "20130601"}], "brand_name": "Nicotine Polacrilex, Original", "product_id": "68016-287_b3555bc9-16a9-4ba6-a2cb-5c40ac2129c4", "dosage_form": "GUM, CHEWING", "pharm_class": ["Cholinergic Nicotinic Agonist [EPC]", "Nicotine [CS]"], "product_ndc": "68016-287", "generic_name": "Nicotine Polacrilex", "labeler_name": "Chain Drug Consortium, LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Nicotine Polacrilex, Original", "active_ingredients": [{"name": "NICOTINE", "strength": "4 mg/1"}], "application_number": "ANDA074707", "marketing_category": "ANDA", "marketing_end_date": "20261231", "marketing_start_date": "20130601"}