nicotine

Generic: nicotine polacrilex

Labeler: hc jones, inc.
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name nicotine
Generic Name nicotine polacrilex
Labeler hc jones, inc.
Dosage Form LOZENGE
Routes
ORAL
Active Ingredients

nicotine 2 mg/1

Manufacturer
HC Jones, Inc.

Identifiers & Regulatory

Product NDC 83253-978
Product ID 83253-978_b4f990b0-fb2a-472a-b570-de8d42e3c102
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA210711
Listing Expiration 2027-12-31
Marketing Start 2025-03-31

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 83253978
Hyphenated Format 83253-978

Supplemental Identifiers

RxCUI
359817
UPC
0850083379070
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 (source: ndc)
Generic Name nicotine polacrilex (source: ndc)
Application Number ANDA210711 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 2 mg/1
source: ndc
Packaging
  • 27 LOZENGE in 1 BOTTLE, PLASTIC (83253-978-27)
  • 1 BOTTLE, PLASTIC in 1 BOX (83253-978-72) / 27 LOZENGE in 1 BOTTLE, PLASTIC
  • 3 BOTTLE, PLASTIC in 1 BOX (83253-978-81) / 27 LOZENGE in 1 BOTTLE, PLASTIC
source: ndc

Packages (3)

83253-978-27 27 LOZENGE in 1 BOTTLE, PLASTIC (83253-978-27) 83253-978-72 1 BOTTLE, PLASTIC in 1 BOX (83253-978-72) / 27 LOZENGE in 1 BOTTLE, PLASTIC 83253-978-81 3 BOTTLE, PLASTIC in 1 BOX (83253-978-81) / 27 LOZENGE in 1 BOTTLE, PLASTIC

Ingredients (1)

nicotine (2 mg/1)

Linked Drug Pages (1)

Nicotine ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "b4f990b0-fb2a-472a-b570-de8d42e3c102", "openfda": {"nui": ["N0000175706", "M0014836"], "upc": ["0850083379070"], "unii": ["6M3C89ZY6R"], "rxcui": ["359817"], "spl_set_id": ["e07226e8-3be4-46e4-aa4f-c5d88db1ccfa"], "pharm_class_cs": ["Nicotine [CS]"], "pharm_class_epc": ["Cholinergic Nicotinic Agonist [EPC]"], "manufacturer_name": ["HC Jones, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "27 LOZENGE in 1 BOTTLE, PLASTIC (83253-978-27)", "package_ndc": "83253-978-27", "marketing_start_date": "20250331"}, {"sample": false, "description": "1 BOTTLE, PLASTIC in 1 BOX (83253-978-72)  / 27 LOZENGE in 1 BOTTLE, PLASTIC", "package_ndc": "83253-978-72", "marketing_start_date": "20250331"}, {"sample": false, "description": "3 BOTTLE, PLASTIC in 1 BOX (83253-978-81)  / 27 LOZENGE in 1 BOTTLE, PLASTIC", "package_ndc": "83253-978-81", "marketing_start_date": "20250331"}], "brand_name": "Nicotine", "product_id": "83253-978_b4f990b0-fb2a-472a-b570-de8d42e3c102", "dosage_form": "LOZENGE", "pharm_class": ["Cholinergic Nicotinic Agonist [EPC]", "Nicotine [CS]"], "product_ndc": "83253-978", "generic_name": "nicotine polacrilex", "labeler_name": "HC Jones, Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Nicotine", "active_ingredients": [{"name": "NICOTINE", "strength": "2 mg/1"}], "application_number": "ANDA210711", "marketing_category": "ANDA", "marketing_start_date": "20250331", "listing_expiration_date": "20271231"}