nicotine polacrilex

Generic: nicotine polacrilex

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

Drug Facts

Product Profile

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

nicotine 4 mg/1

Manufacturer
Padagis Israel Pharmaceuticals Ltd

Identifiers & Regulatory

Product NDC 45802-957
Product ID 45802-957_140e675c-04c5-4d3f-99e6-2bcc2d6395e5
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA203690
Listing Expiration 2026-12-31
Marketing Start 2016-07-08

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 45802957
Hyphenated Format 45802-957

Supplemental Identifiers

RxCUI
359818
UPC
0012345678905
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 (source: ndc)
Generic Name nicotine polacrilex (source: ndc)
Application Number ANDA203690 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 4 mg/1
source: ndc
Packaging
  • 3 CONTAINER in 1 CARTON (45802-957-02) / 27 LOZENGE in 1 CONTAINER (45802-957-01)
source: ndc

Packages (1)

45802-957-02 3 CONTAINER in 1 CARTON (45802-957-02) / 27 LOZENGE in 1 CONTAINER (45802-957-01)

Ingredients (1)

nicotine (4 mg/1)

Linked Drug Pages (1)

Nicotine Polacrilex ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "140e675c-04c5-4d3f-99e6-2bcc2d6395e5", "openfda": {"nui": ["N0000175706", "M0014836"], "upc": ["0012345678905"], "unii": ["6M3C89ZY6R"], "rxcui": ["359818"], "spl_set_id": ["f6cc8d50-2d8d-4ed4-930a-a2479b1ebffe"], "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": "3 CONTAINER in 1 CARTON (45802-957-02)  / 27 LOZENGE in 1 CONTAINER (45802-957-01)", "package_ndc": "45802-957-02", "marketing_start_date": "20160708"}], "brand_name": "Nicotine Polacrilex", "product_id": "45802-957_140e675c-04c5-4d3f-99e6-2bcc2d6395e5", "dosage_form": "LOZENGE", "pharm_class": ["Cholinergic Nicotinic Agonist [EPC]", "Nicotine [CS]"], "product_ndc": "45802-957", "generic_name": "Nicotine Polacrilex", "labeler_name": "Padagis Israel Pharmaceuticals Ltd", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Nicotine Polacrilex", "active_ingredients": [{"name": "NICOTINE", "strength": "4 mg/1"}], "application_number": "ANDA203690", "marketing_category": "ANDA", "marketing_start_date": "20160708", "listing_expiration_date": "20261231"}