good sense nicotine (0113-5023)

Drug Facts

Product Profile

Brand Name good sense nicotine

Generic Name nicotine polacrilex

Labeler l. perrigo company

Dosage Form LOZENGE

Routes

ORAL

Active Ingredients

nicotine 4 mg/1

Manufacturer

L. Perrigo Company

Identifiers & Regulatory

Product NDC 0113-5023

Product ID 0113-5023_5c89061b-1452-4962-9f25-212f2ae8e41e

Product Type HUMAN OTC DRUG

Marketing Category ANDA

Application Number ANDA077007

Listing Expiration 2026-12-31

Marketing Start 2024-04-18

Pharmacologic Class

Established (EPC)

cholinergic nicotinic agonist [epc]

Chemical Structure

nicotine [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 01135023

Hyphenated Format 0113-5023

Supplemental Identifiers

RxCUI

359818

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 good sense nicotine (source: ndc)

Generic Name nicotine polacrilex (source: ndc)

Application Number ANDA077007 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

4 mg/1

source: ndc

Packaging

2 CONTAINER in 1 CARTON (0113-5023-27) / 40 LOZENGE in 1 CONTAINER
40 LOZENGE in 1 CONTAINER (0113-5023-58)
1 CONTAINER in 1 CARTON (0113-5023-60) / 20 LOZENGE in 1 CONTAINER

source: ndc

Packages (3)

0113-5023-27 2 CONTAINER in 1 CARTON (0113-5023-27) / 40 LOZENGE in 1 CONTAINER 0113-5023-58 40 LOZENGE in 1 CONTAINER (0113-5023-58) 0113-5023-60 1 CONTAINER in 1 CARTON (0113-5023-60) / 20 LOZENGE in 1 CONTAINER

Ingredients (1)

nicotine (4 mg/1)

Linked Drug Pages (1)

Good Sense Nicotine ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

{"route": ["ORAL"], "spl_id": "5c89061b-1452-4962-9f25-212f2ae8e41e", "openfda": {"nui": ["N0000175706", "M0014836"], "unii": ["6M3C89ZY6R"], "rxcui": ["359818"], "spl_set_id": ["5c89061b-1452-4962-9f25-212f2ae8e41e"], "pharm_class_cs": ["Nicotine [CS]"], "pharm_class_epc": ["Cholinergic Nicotinic Agonist [EPC]"], "manufacturer_name": ["L. Perrigo Company"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "2 CONTAINER in 1 CARTON (0113-5023-27)  / 40 LOZENGE in 1 CONTAINER", "package_ndc": "0113-5023-27", "marketing_start_date": "20240418"}, {"sample": false, "description": "40 LOZENGE in 1 CONTAINER (0113-5023-58)", "package_ndc": "0113-5023-58", "marketing_start_date": "20240418"}, {"sample": false, "description": "1 CONTAINER in 1 CARTON (0113-5023-60)  / 20 LOZENGE in 1 CONTAINER", "package_ndc": "0113-5023-60", "marketing_start_date": "20240418"}], "brand_name": "Good Sense Nicotine", "product_id": "0113-5023_5c89061b-1452-4962-9f25-212f2ae8e41e", "dosage_form": "LOZENGE", "pharm_class": ["Cholinergic Nicotinic Agonist [EPC]", "Nicotine [CS]"], "product_ndc": "0113-5023", "generic_name": "nicotine polacrilex", "labeler_name": "L. Perrigo Company", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Good Sense Nicotine", "active_ingredients": [{"name": "NICOTINE", "strength": "4 mg/1"}], "application_number": "ANDA077007", "marketing_category": "ANDA", "marketing_start_date": "20240418", "listing_expiration_date": "20261231"}