nicotine

Generic: nicotine polacrilex

Labeler: padagis israel pharmaceuticals ltd
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name nicotine
Generic Name nicotine polacrilex
Labeler padagis israel pharmaceuticals ltd
Dosage Form GUM, CHEWING
Routes
ORAL
Active Ingredients

nicotine 4 mg/1

Manufacturer
Padagis Israel Pharmaceuticals Ltd

Identifiers & Regulatory

Product NDC 45802-651
Product ID 45802-651_4a219ea1-7256-45df-8c6c-b9b7704ed5cc
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA206393
Listing Expiration 2026-12-31
Marketing Start 2023-08-14

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 45802651
Hyphenated Format 45802-651

Supplemental Identifiers

RxCUI
311975
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 ANDA206393 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 4 mg/1
source: ndc
Packaging
  • 110 BLISTER PACK in 1 CARTON (45802-651-25) / 1 GUM, CHEWING in 1 BLISTER PACK
source: ndc

Packages (1)

45802-651-25 110 BLISTER PACK in 1 CARTON (45802-651-25) / 1 GUM, CHEWING in 1 BLISTER PACK

Ingredients (1)

nicotine (4 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": "4a219ea1-7256-45df-8c6c-b9b7704ed5cc", "openfda": {"nui": ["N0000175706", "M0014836"], "unii": ["6M3C89ZY6R"], "rxcui": ["311975"], "spl_set_id": ["26edb714-656d-49ca-b875-28972c490e5f"], "pharm_class_cs": ["Nicotine [CS]"], "pharm_class_epc": ["Cholinergic Nicotinic Agonist [EPC]"], "manufacturer_name": ["Padagis Israel Pharmaceuticals Ltd"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "110 BLISTER PACK in 1 CARTON (45802-651-25)  / 1 GUM, CHEWING in 1 BLISTER PACK", "package_ndc": "45802-651-25", "marketing_start_date": "20230814"}], "brand_name": "NICOTINE", "product_id": "45802-651_4a219ea1-7256-45df-8c6c-b9b7704ed5cc", "dosage_form": "GUM, CHEWING", "pharm_class": ["Cholinergic Nicotinic Agonist [EPC]", "Nicotine [CS]"], "product_ndc": "45802-651", "generic_name": "nicotine polacrilex", "labeler_name": "Padagis Israel Pharmaceuticals Ltd", "product_type": "HUMAN OTC DRUG", "brand_name_base": "NICOTINE", "active_ingredients": [{"name": "NICOTINE", "strength": "4 mg/1"}], "application_number": "ANDA206393", "marketing_category": "ANDA", "marketing_start_date": "20230814", "listing_expiration_date": "20261231"}