nicotine polacrilex coated ice mint

Generic: nicotine polacrilex

Labeler: amerisourcebergen (good neighbor pharmacy) 46122
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name nicotine polacrilex coated ice mint
Generic Name nicotine polacrilex
Labeler amerisourcebergen (good neighbor pharmacy) 46122
Dosage Form GUM, CHEWING
Routes
BUCCAL
Active Ingredients

nicotine 4 mg/1

Manufacturer
AmerisourceBergen (Good Neighbor Pharmacy) 46122

Identifiers & Regulatory

Product NDC 46122-449
Product ID 46122-449_6b85b10b-2d61-4ac9-93a7-c3e7ef0fdfba
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA204833
Listing Expiration 2026-12-31
Marketing Start 2018-01-09

Pharmacologic Class

Established (EPC)
cholinergic nicotinic agonist [epc]
Chemical Structure
nicotine [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 46122449
Hyphenated Format 46122-449

Supplemental Identifiers

RxCUI
311975 314119
UPC
0346122449588 0346122448581
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 ice mint (source: ndc)
Generic Name nicotine polacrilex (source: ndc)
Application Number ANDA204833 (source: ndc)
Routes
BUCCAL
source: ndc

Resolved Composition

Strengths
  • 4 mg/1
source: ndc
Packaging
  • 40 BLISTER PACK in 1 CARTON (46122-449-58) / 1 GUM, CHEWING in 1 BLISTER PACK
source: ndc

Packages (1)

46122-449-58 40 BLISTER PACK in 1 CARTON (46122-449-58) / 1 GUM, CHEWING in 1 BLISTER PACK

Ingredients (1)

nicotine (4 mg/1)

Linked Drug Pages (1)

Nicotine Polacrilex coated ice mint ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["BUCCAL"], "spl_id": "6b85b10b-2d61-4ac9-93a7-c3e7ef0fdfba", "openfda": {"nui": ["N0000175706", "M0014836"], "upc": ["0346122449588", "0346122448581"], "unii": ["6M3C89ZY6R"], "rxcui": ["311975", "314119"], "spl_set_id": ["c21147f5-da96-424c-9058-24eb751b64ea"], "pharm_class_cs": ["Nicotine [CS]"], "pharm_class_epc": ["Cholinergic Nicotinic Agonist [EPC]"], "manufacturer_name": ["AmerisourceBergen (Good Neighbor Pharmacy) 46122"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "40 BLISTER PACK in 1 CARTON (46122-449-58)  / 1 GUM, CHEWING in 1 BLISTER PACK", "package_ndc": "46122-449-58", "marketing_start_date": "20180109"}], "brand_name": "Nicotine Polacrilex coated ice mint", "product_id": "46122-449_6b85b10b-2d61-4ac9-93a7-c3e7ef0fdfba", "dosage_form": "GUM, CHEWING", "pharm_class": ["Cholinergic Nicotinic Agonist [EPC]", "Nicotine [CS]"], "product_ndc": "46122-449", "generic_name": "Nicotine Polacrilex", "labeler_name": "AmerisourceBergen (Good Neighbor Pharmacy) 46122", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Nicotine Polacrilex", "brand_name_suffix": "coated ice mint", "active_ingredients": [{"name": "NICOTINE", "strength": "4 mg/1"}], "application_number": "ANDA204833", "marketing_category": "ANDA", "marketing_start_date": "20180109", "listing_expiration_date": "20261231"}